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Gold, that is all diagnostics were ever meant to be, Useful information.
I would like to make a case to shut down all hospitals and ALL diagnostic tests across the board in the USA! This is inclusive of all X Ray machines and CT scans + MRI's in there entirety! None of them are worth the risk ! In fact less people would die following a medical visit if we shut down the machines and closed these facilities. Further, shutting these resources off would cause less people to get cancer period.
I say we discontinue all diagnostic tests or preventative care because every one of them makes me anxious which is causing more harm than good not to mention the rampant infections found in all medical facilities!
This would include all cancer tests, Inoculations, all well visits, all physical examinations, any visits to check a mole, any dental cleanings or cavity check ups, flue shots, and even oil changes for your car.
In fact why go to the hospital to have a baby...and get rid of those stupid beeping machines because they cause anxiety every time they alarm !
No more physical exams should be mandatory for life insurance or as a prerequisite to join the armed forces! They cause anxiety and one could end up with an infection!
No surgeries should be allowed either because of the terrible infections rampant in hospitals.
We should just wait until either you are in dire pain or something falls off!!
Prostate-Cancer Test Not Worth Risk, Advisory Panel Says
By Alex Nussbaum - May 21, 2012 5:00 PM
The PSA prostate-cancer test used by half of U.S. men older than 40 carries more risks than benefits and shouldn’t be used to diagnose the disease, a U.S. panel said, reaffirming its earlier advice.
Scientific studies suggest the number of deaths avoided by screening are “very small” compared with risks from testing or treatment that can include infections, incontinence, erectile dysfunction and death, the U.S. Preventive Services Task Force said in a medical journal today. The 16-doctor panel kept its recommendation from last October after some doctors and patient groups said discouraging the tests would cost lives.
Enlarge image
Prostate-Cancer Test Carries More Risk Than Benefit Justin Sullivan/Getty Images
DNA samples on a gel while searching for variations in genetic samples that would point to someone's susceptibility to lung, prostate, breast and colo rectal cancer at the UCSF Comprehensive Cancer Center.
DNA samples on a gel while searching for variations in genetic samples that would point to someone's susceptibility to lung, prostate, breast and colo rectal cancer at the UCSF Comprehensive Cancer Center. Photographer: Justin Sullivan/Getty Images
.Prostate cancer was diagnosed in about 250,000 patients last year and caused 33,700 deaths, the task force said. It is the second-most common malignancy among American men. The report may affect whether insurers pay for tests measuring PSA, a protein associated at high levels with the disease.
“Many men are being subjected to the harms of treatment of prostate cancer that will never become symptomatic,” the panel wrote in the report released by the Annals of Internal Medicine. “There is convincing evidence that PSA-based screening for prostate cancer results in considerable overtreatment.”
The government-sponsored task force is an independent medical advisory group that drew criticism in 2009 for questioning the value of breast-cancer screening in women younger than 50.
In today’s recommendation, the panel urged against screening for all men, updating a 2008 report that found insufficient evidence to use it in those older than 75. The report cited the slow growth of most prostate tumors as well as false positive rates that may be as high as 80 percent.
Caution for Doctors
While doctors are still free to suggest PSA tests, they should be prepared to discuss the potential downsides, the report said. Community- or employer-offered mass screenings should be discontinued, the group said. The guidelines don’t apply to men already diagnosed with the disease.
The findings won the endorsement of the American Cancer Society in an accompanying editorial.
“Americans have been taught for decades to fear all cancer and that the best way to deal with cancer is to find it early and treat it aggressively,” said Otis Brawley, the Atlanta- based society’s chief medical officer. “As a result, many have blind faith in early detection” with “little appreciation of the harms that screening and medical interventions can cause.”
Doctors can also detect prostate tumors through digital rectal exams or ultrasound imaging, the report said. Symptoms of the disease include problems urinating, frequent or painful urination, painful ejaculation or a persistent ache in the back, hips or pelvis, according to the National Cancer Institute.
Protein Test
The PSA exam searches for high levels of prostate-specific antigens. In a 2010 survey, 53 percent of American men older than 40 reported taking the test in the prior two years, according to the U.S. Centers for Disease Control and Prevention.
The panel based its recommendations largely on a U.S. study of 77,000 men who were screened and a European review of 182,000. In the U.S., researchers found no evidence the test reduced deaths. The European trial found the exam lowered the mortality rate. The improvement was due solely to results from Sweden and the Netherlands, while patients in five other countries fared no better after testing, the task force said.
“A substantial percentage of men who have asymptomatic cancer detected by PSA screening have a tumor that either will not progress or will progress so slowly that it would have remained asymptomatic for the man’s lifetime,” the panel said.
One in 1,000
Screening and early treatment prevent no more than one death in a 1,000, they said. Surgery and radiation to combat tumors, meanwhile, cause at least 200 cases of incontinence and erectile dysfunction per 1,000 patients, while as many as five men in 1,000 die within a month of a prostate operation.
The report ignored problems with the U.S. and European data as well as benefits beyond simply avoiding death, said nine doctors who challenged the findings in a second editorial.
The recommendation “could result in delayed diagnosis of curable cancer in young men who may then present with advanced disease, illness and death,” said the physicians, led by William Catalona, a professor of urology at Northwestern University in Chicago. “Elimination of reimbursement for PSA testing would take us back to an era when prostate cancer was often discovered at advanced and incurable stages.”
Prostate cancer screening remains covered “at this time” under Medicare, the U.S. insurance plan for the elderly and disabled, Ellen Griffith, a spokeswoman for the program, said.
Medicare recommends that men discuss the risks and benefits with their doctors, she said in an e-mail before the release of the recommendations. The task force report doesn’t require any action on Medicare’s part, she said.
WellPoint Policy
WellPoint Inc. (WLP), the second-biggest insurer, considers prostate screening “medically necessary” for men from 50 to 75, said Kristin Binns, a spokeswoman, in an e-mail. The Indianapolis-based company will continue to review the medical evidence and “make appropriate decisions as research evolves,” she said.
Tyler Mason, a spokesman for UnitedHealth Group Inc. (UNH), the top private insurer in the U.S., didn’t immediately return messages seeking comment. UnitedHealth is based in Minnetonka, Minnesota.
The task force’s report should put an end to campaigns for mass screening popularized by celebrities and companies that benefit from “the lucrative business” of testing, said the Cancer Society’s Brawley, in his commentary.
“Many advocates for prostate cancer screening have ignored the messages of caution,” he said. For patients, “informed or shared decision making is simply not occurring.”
To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Thank You for your concern Gold/Leon.
I havn't lost anything to date though...
Why thanks Gold, I was under the impression that stage III trials were under way.
Sorry Hungryleon,
Honestly, there is not much to post about the stock or financial situation at this time. If you havn't noticed, it is about a penny or less...That is not worth analyzing. We just have to wait out the storm.
In reference to your constructive criticism, I forget that you are a scientist , science major. I will try to slow down and spellcheck my posts.
Perhaps you could do the same? The last I looked, the words you used in your recent post(s) are not in the dictionary or are incorrectly used...
Latests, stearing, lowsy & managment
Further, a possesive form of Biocurex would be Biocurex's
Your use of specially should probably be especially....
Thanks,
Half Full
Goldseeker,
I disagree with your statement. This has a lot to do with Recaf. Look at all of the items that have received a CLIA waiver.
This latest one has a low sensitivity / specificity and yet the FDA approves it. They pick and choose similar tests and approve one but hold up a similar test for something else on the same graounds that they approved the first.
Amazing
I keep picturing the two tests being administered at the same time.
The first tests for Aids and it performs well or badley and the patient dosn't implode or explode.
The second is a Recaf test that performs well or badley and it is if they catch on fire screeming bloody murder down the hallway of the doctors office.
The reality is they are both blood tests. Why approve the one with a poor sensitivity / sprcificity and then disaprove a test that is a better specificity / sensitivity?
It makes no sense to me at all.
The Food and Drug Administration (FDA) has approved several rapid HIV tests as waived tests under CLIA. Waived tests must use unprocessed specimens (whole blood or oral fluid), be easy to use, and have little risk of an incorrect result. So far, more than 1,400 test systems have been waived. A Certificate of Waiver is one of four types of certificates issued under CLIA, and is the type to request if you plan to conduct only waived rapid HIV tests.
http://www.cdc.gov/hiv/topics/testing/resources/factsheets/roltCLIA.htm
Recap
In-Home HIV Test Gets Unanimous Approval Recommendation
Major talking points at the advisory committee hearing were the test’s sensitivity and specificity. An assay’s sensitivity reflects its ability to prevent false negatives—an HIV antibody-negative result for someone who is infected with the virus. An assay’s specificity reflects its ability to prevent false positives—an HIV antibody-positive results for someone who is not infected with the virus.
The OraQuick In-Home HIV Test has strong specificity (99.98 percent). Whereas the OTC test will yield one false-positive result for every 3,750 true-negative results among people who aren’t infected with HIV, the professional oral swab Oraquick test yields one false-positive for every 462 true-negative results.
The OTC’s sensitivity, however, averaged only 92.98 percent, compared with the 99 percent sensitivity associated with the professional OraQuick oral swab-based assay. For every 13 “true-positive” results using the In-Home OraQuick test, there may be one false-negative test result—or approximately 3,800 false-negative test results per year—an analysis of the Phase III clinical trial data showed.
Of particular concern to the FDA presenters was the lower end of the estimated sensitivity range in the Phase III clinical trial—the “lower bound of the 95 percent confidence interval” in statistical parlance. Accordingly, the sensitivity may be as low as 86.64 percent, which is significantly lower than the 95 percent that has historically been required by the FDA’s Blood Products Advisory Committee.
Looking solely at the “lower bound” analysis, there could be one false negative for every six true-positive results using the OraQuick In-Home HIV Test—approximately 7,000 false-negative test results per year. By comparison, the “lower bound” sensitivity using the professional OraQuick oral-based HIV test would be expected to yield one false-negative for every 62 true-positive results.
What is CLIA waived?
Tests that meet certain provisions may be waived, which means that they are simple lab procedures cleared for home use by the Food and Drug Administration.
These tests must be accurate and easy, making it unlikely for mistakes to occur. Should someone perform these tests incorrectly, there should be no reasonable risk of harm.
What tests are CLIA waived?
Congress revised CLIA waiver provisions to automatically clear tests that the FDA clears for home use. These tests are:
1. Non-automated urinalysis that uses a dipstick or tablet for bilirubin, glucose, hemoglobin, leukocytes, nitrite, ketone, pH, protein, specific gravity and urobilinogen.
2. Fecal occult blood
3. Urine pregnancy tests that use visual color comparison
4. Ovulation tests that use visual color comparison
5. Non-automated tests for erythrocyte sedimentation rates
6. Non-automated tests for hemoglobin-copper sulfate
7. Blood glucose by glucose monitoring devices for home use
8. Spun microhematocrit
9. Hemoglobin by single analyte instruments
The most common CLIA waived tests are urine pregnancy tests, over-the-counter blood glucose tests, urine dipstick and tablet tests, and ovulation tests.
How does one apply for a CLIA Certificate of Waiver?
The CLIA Application for Certification Form, or CMS-116, is available at the Centers for Medicare & Medicaid Services (CMS) website. Complete this form and mail it to the local State Agency of where your lab is located.
Process time for CLIA certification takes approximately two months once the form has been received. Once Form CMS-116 is submitted to the State Agency and is processed, you will be issued a fee remittance coupon. The fee remittance coupon will indicate your CLIA ID, the amount to be paid for the certificate, as well as any other fees. Certificate fees vary, depending on the number and type of tests performed in your laboratory.
Contact your State Agency to see if there are any additional forms that are necessary for the registration process.
This Article is written by Lena Butler, contributor of Test Country Articles.
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Interesting that the HIV test falls under the CLIA Waiver !
http://www.orasure.com/products-infectious/products-infectious-oraquick.asp
And so do many other tests
http://www.americanscreeningcorp.com/Clia-Waived-Drug-Tests-C223.aspx
CLIA Waivers
The Law (Public Law 100-578)
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) law specified that laboratory requirements be based on the complexity of the test performed and established provisions for categorizing a test as waived. Tests may be waived from regulatory oversight if they meet certain requirements established by the statute. The section of the statute specifying the criteria for categorizing a test as waived was excerpted without elaboration in the regulations at 42 CFR 493.15(b) and 493.15(c) contained a list of these waived tests as described below.
The Regulations (42 CFR part 493)
On February 28, 1992, regulations were published to implement CLIA. In the regulations, waived tests were defined as simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.
The specified tests that are listed in the regulation are:
Dipstick or Tablet reagent urinalysis (non automated) for the following:
Bilirubin
Glucose
Hemoglobin
Ketone
Leukocytes
Nitrite
pH
Protein
Specific gravity
Urobilinogen
Fecal occult blood
Ovulation tests - visual color comparison tests for luteinizing hormone
Urine pregnancy tests - visual color comparison tests
Erythrocyte sedimentation rate-non-automated
Hemoglobin-copper sulfate - non-automated
Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use
Spun microhematocrit
(added 1/19/93) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout
In November 1997, the CLIA waiver provisions were revised by Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver. Professional use versions of home use tests are not automatically waived. However, such professional versions do qualify for expedited waiver review since only the differences between the home use and professional use versions need to be examined to determine whether the professional version qualifies for waiver.
To summarize, under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use.
In-Home HIV Test Gets Unanimous Approval Recommendation
by Tim Horn May, 15, 2012
Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.
The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?
The particulars of the second question were hotly discussed throughout the May 15 meeting in Gaithersburg, Maryland. Of concern to the FDA presenters and advisory committee panelists is the test’s reduced sensitivity—its effectiveness at screening for HIV antibodies in those infected with the virus—compared with the professional oral swab OraQuick assay.
However, even with reduced sensitivity, Elliott Cowan, PhD, of the FDA acknowledged, the in-home HIV test is anticipated to have a net public health benefit. "The OraQuick In-Home HIV Test is expected to be associated with a net increase in the number of HIV infections newly identified each year," he said, "with evidence of new infections averted with use of the test."
Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone operator. The retail price is between $30 and $40.
The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The retail price of the test is not yet known.
Major talking points at the advisory committee hearing were the test’s sensitivity and specificity. An assay’s sensitivity reflects its ability to prevent false negatives—an HIV antibody-negative result for someone who is infected with the virus. An assay’s specificity reflects its ability to prevent false positives—an HIV antibody-positive results for someone who is not infected with the virus.
The OraQuick In-Home HIV Test has strong specificity (99.98 percent). Whereas the OTC test will yield one false-positive result for every 3,750 true-negative results among people who aren’t infected with HIV, the professional oral swab Oraquick test yields one false-positive for every 462 true-negative results.
The OTC’s sensitivity, however, averaged only 92.98 percent, compared with the 99 percent sensitivity associated with the professional OraQuick oral swab-based assay. For every 13 “true-positive” results using the In-Home OraQuick test, there may be one false-negative test result—or approximately 3,800 false-negative test results per year—an analysis of the Phase III clinical trial data showed.
Of particular concern to the FDA presenters was the lower end of the estimated sensitivity range in the Phase III clinical trial—the “lower bound of the 95 percent confidence interval” in statistical parlance. Accordingly, the sensitivity may be as low as 86.64 percent, which is significantly lower than the 95 percent that has historically been required by the FDA’s Blood Products Advisory Committee.
Looking solely at the “lower bound” analysis, there could be one false negative for every six true-positive results using the OraQuick In-Home HIV Test—approximately 7,000 false-negative test results per year. By comparison, the “lower bound” sensitivity using the professional OraQuick oral-based HIV test would be expected to yield one false-negative for every 62 true-positive results.
“Understanding the public health implications of approving an over-the-counter test that performs at this level of sensitivity and specificity in the hands of lay users is challenging,” the FDA notes in their pre-advisory committee meeting briefing document. “There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status. However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected (false negatives).”
Public testimony at the hearing was overwhelmingly favorable. Roughly 20 agency representatives—including Phill Wilson of the Black AIDS Institute, Cornelius Baker of the Whitman-Walker Clinic in Washington, DC, Dawn Averitt-Bridge of The Well Project, Larry Bryant of Housing Works, C. Virginia Fields of the National Black Leadership Commission on AIDS and Ernest Hopkins of the San Francisco AIDS Foundation—testified that the Oraquick In-Home HIV Test would be a welcome addition to the HIV testing and awareness tool box, particularly for women and people of color living with, and at risk for, HIV who are not being effectively connected to existing testing programs.
“We are concerned by the data indicating that when administered by consumers the accuracy of the rapid HIV tests drops to 93 percent as compared to 99 percent when conducted by professionals,” testified Kimberly Crump, policy officer at the HIV Medicine Association. Yet, Crump noted, “we still believe the rapid test holds great promise as a self-directed tool for individuals to learn their HIV status. We also urge continued research and education in heavily impacted areas and with the low income and minority populations disproportionately affected by HIV infection to determine how the instructions and accompanying support materials can raise the assurance of the test results closer to the level obtained by professionals.”
The advisory committee panelists also noted, on several occasions, the need for strong, clear and concise information in the educational materials that will accompany the test to minimize human error, spell out the risks of false-negative test results and, importantly, to link those who do test positive to licensed health care providers for follow-up testing and care.
“There has been a lot of talk about the false-negative test results,” said Steven Pipe, MD, of the University of Michigan and a member of the panel. “But I still can’t get over the fact that 20 percent of people living with HIV haven’t been tested. If the in-home test helps to reduce this number, its benefits ultimately outweigh its risks.”
Search: hiv, oraquick, orasure, home, hiv test, oral, fda, blood products advisory committee, approval
Funding opportunity
Biomarker imaging
http://biqsfp.cancer.gov/objects/pdfs/2012-BIQSFP-Announcement.pdf
Biomarker detection of cancer requires more sensitivity
One of the central tenets of oncology is that cancers are most susceptible to treatment when diagnosed early, and the earlier the better. For example, 90 percent of women diagnosed with stage I ovarian cancer will survive five years or more, while fewer than 30 percent of those diagnosed with stage III disease will be alive in five years. This harsh reality has prompted a concerted effort to find molecules in blood – biomarkers – that would signal the presence of a tumor before it is detectable by imaging and long before it begins to spread throughout the body.
That search might be more difficult than initially thought given the predictions from a mathematical model developed by Sanjiv Gambhir of Stanford University and post-doctoral fellow Sharon Hori. In a paper published in the journal Science Translational Medicine, the two researchers present work suggesting that current clinical biomarkers for ovarian cancer are unlikely to be detectable until a tumor has been growing for at least a decade and contained almost 2 billion cells. Such a tumor would be 25 millimeters in diameter, about the size of an olive.
According to these calculations, it would take at least 10 years of growth to detect biomarkers shed at this rate using detection technology available today in clinical laboratories. They noted that to be detectable at an early enough time to be clinically useful, a biomarker would have to shed at levels 10,000 greater than CA125 or other known cancer biomarkers. By varying the parameters in the model, the investigators calculated that a 10-fold increase in biomarker shedding rate or a 10-fold decrease in assay detection limit could allow for the detection of a tumor only five millimeters in diameter that had been growing for nearly eight years. The researchers noted that while it is important that biomarker discovery efforts continue, there must be parallel efforts to improve the sensitivity of biomarker detection technologies.
Science Daily - A new blood test is twice as sensitive and can detect breast cancer recurrence a full year earlier than current blood tests.
"We have identified a group of nine biomarkers that signal recurrence of breast cancer," Raftery said. "Our markers detect twice as many recurrences as the CA marker does at the same specificity. They also detect cancer recurrence earlier, about 11-12 months sooner than existing tests. They accomplish this with blood samples, rather than biopsies, with less discomfort to patients."
To find these markers, Raftery's team at Purdue University and Matrix-Bio, Inc., a company he founded, analyzed many hundreds of "metabolites" in the blood of breast cancer survivors.
Most clinical blood biomarkers lack the necessary sensitivity and specificity to reliably detect cancer at an early stage, when it is best treatable. It is not yet clear how early a clinical blood assay can be used to detect cancer or how biomarker-based strategies can be improved to enable earlier detection of smaller tumors. To address these issues, we developed a mathematical model describing dynamic plasma biomarker kinetics in relation to the growth of a tumor, beginning with a single cancer cell. To exemplify a realistic scenario in which biomarker is shed by both cancerous and noncancerous cells, we primed the model on ovarian tumor growth and CA125 shedding data, for which tumor growth parameters and shedding rates are readily available in published literature. We found that a tumor could grow unnoticed for more than 10.1 years and reach a volume of about p/6(25.36 mm)3, corresponding to a spherical diameter of about 25.36 mm, before becoming detectable by current clinical blood assays. Model parameters were perturbed over log orders of magnitude to quantify ideal shedding rates and identify other blood-based strategies required for early submillimeter tumor detectability. The detection times we estimated are consistent with recently published tumor progression time lines based on clinical genomic sequencing data for several cancers. Here, we rigorously showed that shedding rates of current clinical blood biomarkers are likely 104-fold too low to enable detection of a developing tumor within the first decade of tumor growth. The model presented here can be extended to virtually any solid cancer and associated biomarkers.
If you liked this article, please give it a quick review on ycombinator or StumbleUpon. Thanks
POSTED BY BRIAN WANG AT 5/02/2012
LABELS: BIOMARKERS, CANCER, MEDICINE, SCIENCE
GOLD STATED,"Lets say a miracle occurs and it is approved tomorrow. Moro would need to license the technology. Lets say he gets that done in a year."
Gold, This action alone would increase the stock substantially !
Did you ever consider that Dr.Moro is also an investor?
BioCurex Provides Shareholder Update on Recent Events at the Company
Thursday 19 April 2012
BioCurex Inc. (OTCBB:BOCX) is providing this update to shareholders in light of recent significant events at the company since our last update in January. Overall, the Company continues to make progress on several fronts.
OncoPet Diagnostics
BioCurex has recently announced two distribution agreements with Butler Schein Animal Health and Animal Health International, two of the largest animal health companies, for the commercial launch of its RECAF blood test for cancer in dogs. The Company is managing this launch through its wholly-owned subsidiary, OncoPet Diagnostics. The first phase of the sales and marketing effort with these distributors involved preparing marketing materials and training their sales forces on our product. These efforts are now complete and both distributors have provided the Company with preliminary sales targets for the first year of marketing.
Although anticipated to be relatively small, the Company expects to report its first significant product revenue in its 10-year history in the second quarter of this year. The Company has the resources to meet the distribution requirements to supply kits and the laboratory staffing to run the tests and report results back to the vets.
In order to expand the vet market and reach profitability potentially sooner, the Company plans to initiate development of its RECAF test for cats. Based on preliminary findings, the Company believes that the nearly identical cancer test for dogs can be applied to cats. There are approximately as many cats as dogs in the pet marketplace which opens the possibility that introducing the test for cancer in cats can increase sales using the same distributors.
"OncoPet Diagnostics is providing testing services in a similar manner to traditional clinical laboratories," stated Dr Ricardo Moro, BioCurex CEO. "One notable distinction is that we produce all the necessary reagents to extract the sample, which our distributors sell to veterinary clinics. The veterinarian then sends the blood sample to our facilities, where the testing service is performed. This ensures the highest quality control standards, is more profitable than selling test kits and requires no regulatory approvals."
OncoPet Diagnostics has developed a sophisticated software system to manage the ordering, testing and reporting process. This system can be efficiently replicated, which allows for future expansion with minimal expense, as well as facilitate remote monitoring and quality control.
The processing capacity of OncoPet's current testing facilities is estimated to be approximately 500-1,000 RECAF tests per day. In British Columbia alone, with a population just exceeding 4 million, over 120,000 routine blood tests are carried out on pets every year.
"The fact that we are commercializing the OncoPet RECAF test directly does not preclude us from licensing our technology or joint venturing with other veterinarian diagnostic companies," noted Dr. Moro. "Each particular opportunity will be evaluated on a one-on-one basis."
Additionally Dr. Moro noted, "It is important to keep in mind that the OncoPet RECAF test for companion animals is not a substitution for our RECAF tests designed to detect cancer in human patients, but rather an addition aimed to accelerate revenue generation while the human tests move through the pre-marketing phases before commercialization. This represents a major step in our diligent work on all fronts to make BioCurex, Inc. a commercially successful enterprise."
Pre-IDE Meeting with FDA
The pre-IDE process is designed to help companies obtain early, informal input on aspects of a future IDE application and offers assistance in establishing the parameters for official IDE applications when unique diagnostic tests involving innovative technologies are being pursued.
In October 2011, the Company submitted scientific information and a request for a meeting regarding an Investigational Device Exemption (IDE) to the Food and Drug Administration for the use of RECAF in conjunction with PSA to decrease the number of unnecessary prostate biopsies. In addition, the RECAF technology could be used for monitoring recurrence of breast cancers for which there are no effective markers. The predicates for a 510K application would be CEA and CA.15.3 which are routinely used. CEA and CA15.3 are elevated in only 40-50% and 50-70%, respectively, of patients with distant metastases (with 5% false positives). At the same false positive rate, RECAF detects breast cancer in approximately 93% of breast cancers.
Due to limited resources, the Company decided to focus primarily on the vet side of the business and only continue with a few key human applications of the RECAF test until additional resources are available.
Financing
We are pursuing all avenues of capital including debt, equity, or any combination that makes sense for the Company and its shareholders. Capital is necessary to assure the Company can continue to work to increase revenue, advance its technology platform, pursue strategic partnerships and ultimately increase shareholder value. We would like to thank our shareholders for their continued support of BioCurex and we reiterate our commitment to continue working hard toward bringing this exceptional technology to cancer patients.
Management is planning a conference call with shareholders in May to further address our progress and give shareholders a chance to ask questions. Details regarding the call will follow.
About BioCurex, Inc.
BioCurex, Inc. is a biotechnology company that is developing products based on patented and proprietary technology in the area of cancer diagnostics. The technology identifies a universal cancer marker known as RECAF.
RECAF is a molecule that is present on cancer cells but not detected in significant levels on healthy cells or benign tumor cells. It is the receptor for alpha-fetoprotein and is classified as an oncofetal antigen due to its presence on both fetal and malignant tissues. This characteristic makes RECAF a more accurate indicator of cancer than most current tumor markers.
BioCurex is commercializing its technology through licensing arrangements with companies that develop and market diagnostic tests for the large automated clinical laboratory setting, through development and marketing of non-automated clinical laboratory tests, through development of rapid, point-of-care test formats, and through marketing of its OncoPet RECAF test for cancer in companion animals.
BioCurex has signed licensing agreements for its cancer detection blood tests with Abbott Laboratories (NYSE:ABT) and with Inverness Medical Innovations.
For further information on these agreements visit: http://sec.gov/Archives/edgar/data/1092562/000100487808000117/sb2amnd4s1april08.txt.
For more information about the Company, please visit www.BioCurex.com.
For more information about OncoPet Diagnostics Inc., please visit: www.OncoPetDiagnostics.com.
Forward-Looking Statements
The Company has not authorized the release of this information in any form that contravenes the Communication Act and will not be responsible for unsolicited massive distribution of this material by e-mail or facsimile by unauthorized parties. Statements in this press release, which are not historical facts, are "forward-looking statements" within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
CONTACT: Company Contact:
Antonia Haughton
BioCurex, Inc.
(604) 207 9150
http://www.biocurex.com
Investor Relations Contact:
DC Consulting
(407) 792-3333
investorinfo@dcconsultingllc.com
Interesting twist...Compassionate use
Expanded access
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(Redirected from Compassionate use)
Expanded access refers to the use of an investigational drug outside of a clinical trial by patients with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress. This type of access may be available, in accordance with United States Food and Drug Administration (FDA) regulations, when it is clear that patients may benefit from the treatment, the therapy can be given safely outside the clinical trial setting, no other alternative therapy is available, and the drug developer agrees to provide access to the drug. The FDA refers to such a program as an expanded access program (EAP).[1] EAPs can be leveraged in a wide range of therapeutic areas including HIV/AIDS and other infectious diseases, cancer, rare diseases, and cardiovascular diseases, to name a few.
There are several types of EAPs allowed in the United States. Treatment protocols and treatment INDs provide large numbers of patients access to investigational drugs. A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to an investigational drug on an emergency or compassionate use basis.[2] When the FDA receives a significant number of requests (~10 to 100) for individual patient expanded access to an investigational drug for the same use, they may ask the trial sponsor to consolidate these requests, creating an intermediate-size group.[3] “Compassionate use” is a more colloquial term that is not generally used by the FDA.
Look up investigational, drug, compassionate, expanded, or access in Wiktionary, the free dictionary.
Contents [hide]
1 FDA regulations
2 Outside the United States
3 References
4 External links
[edit]FDA regulations
Since 1987, the FDA has had rules in place that have enabled patients, under specific circumstances, to access drugs or biologics that are still in development for treatment purposes. These expanded access program rules were amended in 2009 by the FDA to ensure “broad and equitable access to investigational drugs for treatment.”[4]
The regulations include the following:[4]
Criteria that must be met in order to authorize the expanded access use
Requirements for expanded access submissions
Safeguards to protect patients and the clinical trial process
The regulations also include general criteria for granting expanded access:[3]
The patient must have a serious condition or disease for which there is no comparable alternative therapy available
The patient must be unable to participate in a clinical trial
The potential benefit must outweigh the potential risk of using the treatment
There should be no impact on the completion of the clinical trial or the drug’s approval
Despite the updated regulations, debate remains over key elements of expanded access:
Deciding at what point in the clinical trial process access should be given. Some stakeholders support expanded access programs after phase I testing in clinical trials, which establishes the drug’s safety. The FDA, however, believes that most drugs should not be eligible until some point during phase III when efficacy data have been obtained, unless compelling phase II data on safety and efficacy are available.[3][5]
Weighing risks to the patient against the potential benefits. The FDA requires that a physician and an institutional review board (IRB) determine that a treatment will not pose undue risk to the patient, relative to the condition he or she is suffering from.[6] However, the FDA maintains the right to overrule the physician and IRB.[3]
Determining who should get access. The FDA states that expanded access should only be considered for patients with a serious disease or condition, but the FDA’s rules do not provide a definition of “serious”; instead it provides examples of diseases and conditions that fall into this category.[3] In the case of a cancer drug, the sponsor of an expanded access program must define exactly which patients will get access. Most often, access is limited to those patients with the same type of cancer the drug is being tested for.[7]
A number of challenges can exist when patients seek access to investigational drugs:
Obtaining an IRB review. Finding time on an IRB’s schedule can be difficult, particularly for doctors who are not based at research centers where IRBs are readily available. The fee for the review may pose a problem as well. It may be unclear who is responsible for the cost of the IRB review, which can be as much as $2,000. Many IRBs conduct reviews pro bono but others that charge will often only wave their fees for research done in their hospital.[6][8]
Protecting physicians against liability risk. Currently, physicians may be concerned that they could face a liability risk for investigational drugs that they recommend to patients or help them gain access to, potentially discouraging them from doing so. The FDA does not have jurisdiction over this issue but there is a bill in Congress, the Compassionate Access Act of 2010 (H.R. 4732), that would address the situation.[6][8][9]
Paying for the drug. While the FDA allows drug companies to recover the costs of providing a treatment through an EAP, many companies may hesitate to do so because it requires disclosing the cost of their drug, which is often a closely guarded secret. In addition, many insurance companies won’t cover the costs of experimental treatment so access could be limited to patients with the means to pay for it.[6][8]
Assessing the potential impact of adverse events on drug development. Adverse events (AEs) that result from expanded access programs must be reported to the FDA in the same way AEs are reported in the case of a clinical trial. The FDA states that, to their knowledge, no drug candidate has been turned down for approval because of an adverse event that appeared in an expanded access program.[3][6]
[edit]Outside the United States
Outside the U.S., programs that enable access to drugs in the pre-approval and pre-launch phase are referred to by a variety of names including “named patient programs,” “named patient supply” and “temporary authorization for use.”[10] In the EU, named patient programs also allow patients to access drugs in the time period between centralized European Medicines Agency (EMEA) approval and launch in their home countries which can range from one year to eighteen months.[11]
[edit]References
^ US National Cancer Institute - Access to Investigational Drugs accessed April 22, 2007
^ FDA Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
^ a b c d e f Final FDA Rules on Expanded Access to Investigational Drugs for Treatment Use
^ a b FDA website
^ Expanded Access to Investigational Drugs Genetic Engineering & Biotechnology News, January 15, 2010.
^ a b c d e Access to Investigational Drugs Remains Challenge Despite New FDA Rules ‘’The Pink Sheet’’
^ Managing Access to Drugs Prior to Approval and Launch ‘’Life Science Leader’’
^ a b c FDA webinar accessed May 5, 2010
^ FDA Law Blog accessed May 5, 2010
^ Helene S (2010). "EU Compassionate Use Programmes (CUPs): Regulatory Framework and Points to Consider before CUP Implementation". Pharm Med 24 (4): 223–229.
^ [Ericson, M., Harrison, K., Laure, N. & De Crémiers, F., Compassionate Use Requirements in the Enlarged European Union. RAJ Pharma, May 2005: 83.
[edit]External links
Early/Expanded access for medial devices from the US FDA
Guidelines for Expanded Access Protocols from BC (Canada) Cancer Agency
Preapproval Opportunities. Applied Clinical Trials, June 2008.
Boundaries of Expanded Access. Pharmaceutical Executive, May 2008.
A Time for Compassion. Applied Clinical Trials, September 2007.
Cancer Patients Deserve Faster Access to Life-Saving Drugs. Wall Street Journal, May 2, 2009.
Fighting for a Last Chance at Life. New York Times, May 16, 2009.
Expanded Access to Investigational Drugs Genetic Engineering & Biotechnology News, January 15, 2010.
Meeting Global Demand for Investigational Drugs Life Science Leader, December 2009.
Warren Buffett has prostate cancer, sees no danger
Warren Buffett says he has Stage 1 prostate cancer
By Ben Berkowitz
Tue Apr 17, 2012 (Reuters) -
Berkshire Hathaway Inc Chief Executive Warren Buffett said he has stage 1 prostate cancer but his condition "is not remotely life-threatening or even debilitating in any meaningful way."
Buffett, the world's third-richest man, will begin a two-month treatment consisting of daily radiation treatments starting in mid-July, he said in a statement on Tuesday. This will limit his ability to travel during that time, Buffett added.
The news from the 81-year-old "Oracle of Omaha" is likely to intensify the already brewing debate about the succession plan at Berkshire Hathaway, a conglomerate that employs more than 270,000 people in more than 70 businesses around the world.
Doctors say he has a very good prognosis, given the disease's early stage, though some questioned whether he even needed treatment at all given his age.
Buffett told investors in late February that Berkshire had identified his successor, but in typically circumspect fashion, declined to say who it was - and ultimately admitted that even the chosen one does not know, himself.
The news comes one day after Republicans in the U.S. Senate blocked the "Buffett rule," a tax on millionaires whose idea was born of a now-famous editorial Buffett wrote in the New York Times last year, saying the rich had an obligation to pay more income tax.
That debate ensnared Buffett's secretary as well. After Buffett said she paid more taxes than he did, President Barack Obama invited Debbie Bosanek to attend this year's State of the Union address.
Berkshire shares fell 1.5 percent in after-hours trading following Buffett's announcement. The widely held Class B shares are up 5.9 percent year-to-date, half the gains of the broader S&P 500.
PANIC EXPECTED, NOT NEEDED
Stifel Nicolaus analyst Meyer Shields, in a note to clients, said he expected some weakness in the stock on Wednesday but added the news did not necessarily make the succession worries behind his "hold" rating any more imminent.
One Berkshire investor said it was reasonable to assume people would panic at the news of Buffett's illness, but that nothing had actually changed in the case for the stock.
"Despite the news, this is not a reason to sell (Berkshire). Fundamentals are still good at the company and the clear succession plan does give clarity about the future path of the firm," said Michael Yoshikami, chief executive of Destination Wealth Management in California.
Another Berkshire investor who has written books about Buffett's investment strategies said the news could have been much worse and was, ultimately, not a surprise.
"He's mortal, we knew that," said Jeff Matthews, author of the book "Secrets in Plain Sight." "I think it means zero for Berkshire investors. He's been getting the company ready for the day he dies."
There were skeptics, though, who said the news could at least put a cap on the stock, which has underperformed in recent years.
"The uncertainty will diminish the upside to this company," said Doug Kass of Seabreeze Partners in Palm Beach, Florida, which owns B shares.
GOOD PROGNOSIS
The situation may not be that uncertain, though - medical professionals said Buffett faces good odds, even at his age.
Any man diagnosed with stage 1 prostate cancer "has an excellent long-term prognosis," said Jonathan Wright, a urological oncologist at the University of Washington and the Seattle Cancer Care Alliance. "The cancer is in a very curable stage."
Buffett's radiation therapy is standard care. Since the beam is extremely focused, there should be minimal side effects, though mild fatigue and a temporary worsening of urinary and bowel function are not uncommon, according to Mark Litwin, a researcher at UCLA's Jonsson Comprehensive Cancer Center and chairman of the Department of Urology.
"Those dissipate quickly," said Litwin. "A patient is usually able to work while receiving radiation treatment."
One in six American men will get prostate cancer, but only one in 36 will die of it, according to the American Cancer Society. Some doctors even questioned why Buffett was receiving treatment, given his age and since 'active surveillance' is often an option.
"A good number of men with low risk cancer of the prostate can be observed without needing to be treated," said Louis Potters, chairman of radiation medicine at North Shore-LIJ in New York.
Buffett would also not be the first person to keep running a major company while being treated for cancer. AIG CEO Bob Benmosche was diagnosed with an undisclosed cancer 18 months ago and continues to run the bailed-out insurer.
ANNUAL MEETING SCALED BACK
Buffett's condition will now be center stage at Berkshire's annual meeting on May 5. The festival-like event draws more than 40,000 shareholders to the company's headquarters in Omaha, Nebraska.
This year's meeting was expected to focus to some degree on succession, as well as the investment case for Berkshire. For the first time ever, Buffett is expected to take questions from sell-side analysts at the meeting.
Even before the news of Buffett's illness, Berkshire was already scaling back this year's festivities, however.
Among other changes, the company canceled the Sunday press conference Buffett and Vice Chairman Charlie Munger used to hold with international press.
But he is not slowing down much. Fortune writer Carol Loomis, a long-time friend of Buffett's who helps edit his annual letter, reported on Tuesday that Buffett was out on the town one day after his diagnosis, having dinner with the (unrelated) entertainer Jimmy Buffett.
The only major change in his schedule? He skipped his regular Monday night online bridge game, Loomis said.
(Reporting By Ben Berkowitz in Boston; Additional reporting by Phil Wahba, Jen Saba, Sharon Begley, Rodrigo Campos and Jonathan Stempel in New York, Rick Rothacker in Charlotte, Anna Yukhananov in Washington and Alistair Barr in San Francisco; Editing by Gary Hill)
Related Quotes and News
Ultrasound Destroys Prostate Cancer With Few Side Effects
Tuesday, April 17, 2012 6:55 AM
High-intensity focused ultrasound may offer prostate cancer patients a treatment option with fewer side effects by targeting tumors better, according to a study published in the medical journal The Lancet Oncology.
The technology enables doctors to preserve the prostate by aiming only at the cancerous area in contrast to standard treatment, such as irradiation or surgical removal of the gland, which may cause impotence and leakage of urine or feces, researchers in London said in the study published Monday. The technique, also called HIFU, may provide men with an alternative similar to the lumpectomy, in which doctors remove tumors rather than the whole organ in breast-cancer patients, they said.
“The signal from this study is quite strong,” Hashim Ahmed, a urologist at the University College London who was the report’s lead author, said in a phone interview. “When you look at the current standard of care, there’s a 1-in-3, or 1-in-2 chance of having the perfect outcome. In this study, after 12 months, it’s a 9-in-10 chance.”
None of the 41 men in the trial reported urine incontinence and only one in 10 suffered from poor erections 12 months after the treatment, the researchers said. About 95 percent of the men were cancer-free after a year, meaning most had a “perfect outcome” in terms of disease progression and side effects, the authors said.
Larger Trial
The study was carried out in London and funded by the U.K. Medical Research Council, the Pelican Cancer Foundation, and St. Peter’s Trust for Kidney, Bladder & Prostate Research. Ahmed said he’s recruiting patients for a larger trial in the U.K. and is looking for funding.
HIFU is a narrow, focused beam of high-energy sound waves directed at a cancerous area the size of a grain of rice. Doctors using magnetic resonance imaging and mapping biopsies to identify targets and aim the sound waves at affected tissue, causing it to vibrate and heat to about 80 degrees Celsius (176 degrees Fahrenheit) to kill cells, according to the study.
The procedure was performed in the hospital under general anesthesia and most patients were home within 24 hours, the researchers said.
The men in the study were all medium- to high-risk patients whose cancer was likely to spread within a few years and who would have faced surgery or radiotherapy and side effects, Ahmed said. Men who had already received chemotherapy, hormone treatment, or radiation therapy were excluded from the trial.
Smaller Tumors
The technology is “very good for smaller tumors, and it preserves nerves and blood vessels, which is important for sexual function,” said Malcolm Mason, a spokesman on prostate cancer for Cancer Research UK and head of oncology and palliative medicine at Cardiff University.
HIFU may offer better quality of life for low-risk patients who, while not needing surgery or radiation, may be anxious about their condition, Mason said. In these cases, standard treatment isn’t given unless there’s a change in test results such as levels of prostate-specific antigen, or PSA. Low-risk patients may not see their cancer spread for many years.
“Certainly within the prostate field it’s a very encouraging step,” Mason said. “It doesn’t mean that HIFU is better and that men should demand HIFU over any other treatment.”
Cause of Death
Prostate cancer is the sixth most-common cause of cancer death in men worldwide, according to Cancer Research UK. Other treatments being used include cryotherapy, where prostate cancer cells are frozen and destroyed, as well as hormone therapy and chemotherapy.
HIFU may be cheaper than the standard treatment, Ahmed said. The cost of the MRI and mapping was an estimated $2,400 and the HIFU procedure totaled $1,600, he said. That compares with about $7,200 to remove the prostate, he said. Fewer side effects would also cost the health system less, Ahmed said.
The technology may also be applied to other cell-based cancers such as breast, thyroid, pancreas, and liver, Ahmed said.
Copyright Bloomberg News
Read more: Ultrasound Destroys Prostate Cancer With Few Side Effects
Gold, you assume that have some sort of problem....you are incorrect in your assumption.
No. Why go through the hassle when I can just read you multiple Repostings?
Gold that makes zero sense. With your logic, a company could state anything one day and change it back the next day. Ever heard of public records Gold?
I find it interesting that Ricardo Moro held his shares even through the higher priced time period. It is obvious that he believes in Biocurex. He could have made millions some time back.
I anticipate a turnaround that will bring Biocurex stock back up.
He knows the technology will come through. It does take time though.
Canine Hereditary Cancer Consortium
To study canine cancer, scientists, clinicians, and veterinarians from TGen, the Van Andel Research Institute (VARI) and the National Cancer Institute initiated the Canine Hereditary Cancer Consortium (CHCC), a program designed to study naturally occurring cancers in dogs to better understand why both pets and people get sick. The CHCC will take advantage of new genetic resources and technologies to develop genetic screens, diagnostic tests, and treatments for hereditary canine cancers as well as gain insight into the biology of human disease.
We will analyze collected DNA and RNA samples from dogs for genetic patterns that are associated with cancer. These patterns may form the basis of genetic tests that may lead to detecting a gene that contributes an increased risk for developing cancer over a dog's lifetime. Also, these studies may provide important clues about cancer in people.
http://tgen.org/research/index.cfm?pageid=1382
Now that would be awesome to find multiple companies to get together to submit a 20 panel test. Share the costs 20 ways and run one test for approval.
This is the full version
BMC Cancer. 2011; 11: 499.
Published online 2011 November 30. doi: 10.1186/1471-2407-11-499
PMCID: PMC3285105
Copyright ©2011 Cree; licensee BioMed Central Ltd.
Improved blood tests for cancer screening: general or specific?
Ian A Cree1
1Translational Oncology Research Centre, Queen Alexandra Hospital, Southwick Hill, Portsmouth, PO6 3LY, UK
Corresponding author.
Ian A Cree: ian.cree@porthosp.nhs.uk
Received April 28, 2011; Accepted November 30, 2011.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Abstract
Diagnosis of cancer at an early stage leads to improved survival. However, most current blood tests detect single biomarkers that are of limited suitability for screening, and existing screening programmes look only for cancers of one particular type. A new approach is needed. Recent developments suggest the possibility of blood-based screening for multiple tumour types. It may be feasible to develop a high-sensitivity general screen for cancer using multiple proteins and nucleic acids present in the blood of cancer patients, based on the biological characteristics of cancer. Positive samples in the general screen would be submitted automatically for secondary screening using tests to help define the likelihood of cancer and provide some indication of its type. Only those at high risk would be referred for further clinical assessment to permit early treatment and mitigate potential overdiagnosis. While the assays required for each step exist, they have not been used in this way. Recent experience of screening for breast, cervical and ovarian cancers suggest that there is likely to be widespread acceptance of such a strategy.
Other Sections?
Introduction
Several successful screening programmes are already well established, but these are currently applicable only to common cancers such as the faecal occult blood test [1] for colorectal cancer, mammography for breast cancer [2] and, of course, cervical cytology for cervical cancer and dysplasia, which is becoming ever more sophisticated [3,4]. Despite many attempts, blood tests have a less distinguished record. For instance, prostate-specific antigen screening is widely used despite its well-publicised problems [5]. It remains controversial and generates large numbers of papers every year (2, 032 were indexed in PubMed through 2010 using the search terms 'screening', 'prostate specific antigen' and 'cancer'). Many other tumour markers have been described, usually in relatively small studies, and few make it through to clinical use. Cancer antigen 125 (CA 125) was first described as a marker of ovarian cancer in 1981 [6] and is still being evaluated as a potential screening test [7,8].
Despite its history, blood-based screening for cancer remains attractive, as it could provide inexpensive testing that would arguably be more acceptable to patients and easily incorporated into an annual checkup, which might include cholesterol and other assays of general health. This idea was judged too risky to be funded when put forward in 2005, but six years later, the recent review along similar lines by Hanash et al. [9] has shown how fast the necessary underlying science is advancing. There is no doubt that cancers have characteristics that could be detected by performing blood-based screening tests (Figure ?(Figure1).1). In 2000, Hanahan and Weinberg [10] published their seminal paper describing the Hallmarks of Cancer, and many authors since then have described changes in blood related to these characteristics. Hanahan and Weinberg pointed out that cancer cell growth is the result of self-sufficiency in growth signals and insensitivity to antigrowth signals. Such signals are often mediated by growth factors, which may rise above normal levels in peripheral blood [11]. Growth has consequences: Even in the early stages there may be detectable metabolic changes [12,13], though these often lack specificity [14]. Cancer cells also upregulate mechanisms that allow them to evade apoptosis, and some of these also cause the release of cytokines into blood [15,16]. Many tumours also have increased cell turnover: They grow because they divide faster than they die, but there is still increased cell death by apoptosis or necrosis. This overloads the local clearance mechanisms for dead cells in tissues and leads to the appearance of partly caspase-digested proteins and DNA fragments in peripheral blood [17-19]. The amount of DNA present is increased and may contain mutations or altered methylation [20-23]. More recently, the presence of RNA, particularly in the form of miRNA [24,25] and exosomes [25-27] derived from cancer cells in blood, has opened up new avenues of research. Tumours require the ability to make new blood vessels, and many therefore produce proangiogenic factors, which can be found in blood [28,29]. They also increase the number of endothelial cell precursors in blood [29]. Immunological abnormalities are common in many cancer patients, with the appearance of autoantibodies to p53 and other intracellular antigens [30]. Finally, malignant cells invade and metastasise. While few metastatic cells survive and grow, their presence can be detected in blood by using sensitive assays [31].
Figure 1
Tumour biomarkers in blood reflect the major processes resulting in tumour formation by cancer cells and the host reaction.
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Discussion
The question, therefore, is, Is it possible to use a general screen that might select a set of individuals from the general population who could then be screened further, initially by using the same blood sample, to confirm whether they have cancer and give some guidance as to type? While the objective of general population screening is to identify individuals with a high risk of cancer, the aims of secondary and finally diagnostic screening would be, respectively, to (1) confirm positivity and (2) determine the type of cancer to assist in the choice of further investigations to perform in a selected at-risk group. The advantage of the two-stage method proposed is that those tests showing greatest specificity often have limited sensitivity. Circulating free DNA is a good example of a test with considerable sensitivity [32,33], but measurement of this alone in patients with inflammatory or other conditions could lead to an unacceptably high false-positive rate and might give little indication of the site of the tumour [34,35]. Equally true is that studies of gene mutations or autoantibodies may have greater specificity but lower sensitivity [21,30].
Preventive maintenance is routine for any complex mechanical device and is increasingly acceptable to healthy people. In most European countries, general medical checkups are encouraged to ensure blood pressure control, and blood tests are used to guide the use of lipid-lowering drugs [36]. Highly successful screening methods are used for specific cancers, as discussed above. However, other common cancers for which no effective screening methods exist include cancers of the lung, stomach, oesophagus, pancreas, liver, head and neck, and kidney. Further, about 25% of cancer deaths occur as a result of cancers outside the 'top 10' common cancer types (Cancer Research UK: Cancer Mortality: UK Statistics. Available at http://info.cancerresearchuk.org/cancerstats/mortality/). Although the economic implications require careful study, it is possible that such screening tests could be cost-neutral to health care providers, since it is likely to be very much more expensive to treat a small number of patients for advanced cancer than to screen and treat a larger number of individuals with early cancer or precancerous conditions. The benefit to patients would be that a frequent, simple, low-risk and relatively painless investigation could prevent serious or life-threatening disease.
If the development of this strategy is successful, we will see a general change from self-referral for cancer symptoms, when treatment is often difficult, costly and unsuccessful, to regular screening using a simple blood test, permitting the treatment of small, localised tumours. New, less invasive radiological and treatment strategies are required, but these are already being introduced, such as laparoscopic surgery for colorectal carcinoma [37] and endomucosal resection of oesophageal cancers [38]. Some of the patients undergoing screening are likely to have anxieties related to the outcomes of their yearly tests, but these are arguably balanced by the knowledge that many cancers caught early are in most cases unlikely to be fatal. The excellent take-up of existing screening procedures (some quite unpleasant for patients) suggests that this is not a major issue, though it is certainly a research need and the introduction of screening procedures requires careful evaluation [39].
The major risk to patients is overdiagnosis, which has been highlighted by other screening programmes [40]. For quantitative blood tests, mitigation of this risk may be feasible by setting test thresholds appropriately so that only those at high risk are referred for further investigation, but this does require careful monitoring and quality assurance is essential.
Many of the problems alluded to are common to most translational research. Test development is the first stage (Table ?(Table1).1). It is unlikely that any one analyte will provide the answer, but several of them tested together or sequentially in the same sample could provide the degree of accuracy needed. This would be particularly attractive if the same or similar technologies were used for detection. The recent use of human epididymis protein 4 and CA 125 detection for ovarian cancer (now approved by the US Food and Drug Administration for monitoring disease) is a case in point where the use of multiple analytes measured by ELISA was found to provide better information than previous screening tests [41]. At present, there are numerous published studies in these areas that could be described as developmental (stage 1) or early clinical testing (stage 2), but few of these (even those with strongly positive results) go on to validation studies (stage 3), which require larger series of well-documented patients. Most stage 2 studies have too few patients to draw firm conclusions. This has recently been noted with regard to pharmacogenomic studies [42] and is by no means the preserve of cancer, where the research community at least has access to valuable information derived from large clinical trials that can be used for cancer screening. Implementation studies that examine the impact and cost-effectiveness of blood screens for cancer are very rare, mainly because they are large, complex, time-consuming and expensive to run.
Table 1
Stages of translation from diagnostic to clinic for diagnostic devicesa
Last, at each stage, the dissemination of results is essential. A quick search of PubMed using the terms 'early', 'detection', 'cancer' and 'validation' produced 481 articles, 100 of which were classified as reviews and only 178 of which were available as free full-text articles. BMC Cancer is, of course, a free full-text journal, and our experience is that publication in this format aids in the dissemination of results beyond the well-funded libraries at major universities and hospitals.
Conclusion
General screens for cancer may be feasible but are unlikely to grow out of existing specialist screening programmes, which concentrate on particular cancer types. Multiplex approaches are likely to be most effective and, with appropriate translational support, could be practicable. There are a number of risks, mainly of overdiagnosis, which need careful management. Implementation depends on dissemination of research, and open access journals have their role to play if this is to be become a reality.
Abbreviations
CA 125: cancer antigen 125; ELISA: enzyme-linked immunosorbent assay; miRNA: microRNA.
Competing interests
IAC is a section editor of BMC Cancer and is a director of NALIA Systems Ltd, a university spinout company developing an antibody array technology for clinical use.
Pre-publication history
The pre-publication history for this paper can be accessed here:
http://www.biomedcentral.com/1471-2407/11/499/prepub
Acknowledgements
I am grateful to many colleagues for discussion of this subject, particularly Dr Pradeep Bhandari and Prof Doug Altman.
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References
Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med. 2008;149:441–450. W81. [PubMed]
Vinnicombe S, Pinto Pereira SM, McCormack VA, Shiel S, Perry N, Dos Santos Silva IM. Full-field digital versus screen-film mammography: comparison within the UK breast screening program and systematic review of published data. Radiology. 2009;251:347–358. doi: 10.1148/radiol.2512081235. [PubMed] [Cross Ref]
Kitchener HC, Blanks R, Cubie H, Desai M, Dunn G, Legood R, Gray A, Sadique Z, Moss S. MAVARIC Trial Study Group. MAVARIC: a comparison of automation-assisted and manual cervical screening: a randomised controlled trial. Health Technol Assess. 2011;15:iii–iv. ix-xi, 1-170. [PubMed]
Dillner J, Rebolj M, Birembaut P, Petry KU, Szarewski A, Munk C, de Sanjose S, Naucler P, Lloveras B, Kjaer S, Cuzick J, van Ballegooijen M, Clavel C, Iftner T. Joint European Cohort Study. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008;337:a1754. doi: 10.1136/bmj.a1754. [PMC free article] [PubMed] [Cross Ref]
Zeliadt SB, Hoffman RM, Etzioni R, Gore JL, Kessler LG, Lin DW. Influence of publication of US and European prostate cancer screening trials on PSA testing practices. J Natl Cancer Inst. pp. 520–523.
Bast RC Jr, Feeney M, Lazarus H, Nadler LM, Colvin RB, Knapp RC. Reactivity of a monoclonal antibody with human ovarian carcinoma. J Clin Invest. 1981;68:1331–1337. doi: 10.1172/JCI110380. [PMC free article] [PubMed] [Cross Ref]
Menon U, Gentry-Maharaj A, Hallett R, Ryan A, Burnell M, Sharma A, Lewis S, Davies S, Philpott S, Lopes A, Godfrey K, Oram D, Herod J, Williamson K, Seif MW, Scott I, Mould T, Woolas R, Murdoch J, Dobbs S, Amso NN, Leeson S, Cruickshank D, McGuire A, Campbell S, Fallowfield L, Singh N, Dawnay A, Skates SJ, Parmar M, Jacobs I. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) Lancet Oncol. 2009;10:327–340. doi: 10.1016/S1470-2045(09)70026-9. [PubMed] [Cross Ref]
Tiss A, Timms JF, Smith C, Devetyarov D, Gentry-Maharaj A, Camuzeaux S, Burford B, Nouretdinov I, Ford J, Luo Z, Jacobs I, Menon U, Gammerman A, Cramer R. Highly accurate detection of ovarian cancer using CA125 but limited improvement with serum matrix-assisted laser desorption/ionization time-of-flight mass spectrometry profiling. Int J Gynecol Cancer. 2011;20:1518–1524.
Hanash SM, Baik CS, Kallioniemi O. Emerging molecular biomarkers: blood-based strategies to detect and monitor cancer. Nat Rev Clin Oncol. 2011;8:142–150. doi: 10.1038/nrclinonc.2010.220. [PubMed] [Cross Ref]
Hanahan D, Weinberg RA. The Hallmarks of Cancer. Cell. 2000;100:57–70. doi: 10.1016/S0092-8674(00)81683-9. [PubMed] [Cross Ref]
Bast RC Jr, Badgwell D, Lu Z, Marquez R, Rosen D, Liu J, Baggerly KA, Atkinson EN, Skates S, Zhang Z, Lokshin A, Menon U, Jacobs I, Lu K. New tumor markers: CA125 and beyond. Int J Gynecol Cancer. 2005;15(Suppl 3):274–281. [PubMed]
Asiago VM, Alvarado LZ, Shanaiah N, Gowda GA, Owusu-Sarfo K, Ballas RA, Raftery D. Early detection of recurrent breast cancer using metabolite profiling. Cancer Res. 2010;70:8309–8318. doi: 10.1158/0008-5472.CAN-10-1319. [PMC free article] [PubMed] [Cross Ref]
Tiziani S, Lopes V, Günther UL. Early stage diagnosis of oral cancer using 1H NMR-based metabolomics. Neoplasia. 2009;11:269–276. [PMC free article] [PubMed]
Nordström A, Lewensohn R. Metabolomics: moving to the clinic. J Neuroimmune Pharmacol. 2010;5:4–17. doi: 10.1007/s11481-009-9156-4. [PubMed] [Cross Ref]
Johansson M, McKay JD, Rinaldi S, Wiklund F, Adami HO, Grönberg H, Kaaks R, Stattin P. Genetic and plasma variation of insulin-like growth factor binding proteins in relation to prostate cancer incidence and survival. Prostate. 2009;69:1281–1291. doi: 10.1002/pros.20972. [PubMed] [Cross Ref]
Carbone A, Rodeck U, Mauri FA, Sozzi M, Gaspari F, Smirne C, Prati A, Addeo A, Novarino A, Robecchi A, Bertetto O, Emanuelli G, Bellone G. Human pancreatic carcinoma cells secrete bioactive interleukin-18 after treatment with 5-fluorouracil: implications for anti-tumor immune response. Cancer Biol Ther. 2005;4:231–241. doi: 10.4161/cbt.4.2.1476. [PubMed] [Cross Ref]
Ueno T, Toi M, Linder S. Detection of epithelial cell death in the body by cytokeratin 18 measurement. Biomed Pharmacother. 2005;59(Suppl 2):S359–S362. [PubMed]
Inaba N, Negishi Y, Fukasawa I, Okajima Y, Ota Y, Tanaka K, Matsui H, Iwasaki H, Sudo H, Tanaka N, Pakk C, Suzuki N, Sekiya S. Cytokeratin fragment 21-1 in gynecologic malignancy: comparison with cancer antigen 125 and squamous cell carcinoma-related antigen. Tumor Biol. 1995;16:345–352. doi: 10.1159/000217951. [Cross Ref]
Wang J, Yi Y, Li B, Wang Z, Sun H, Zhang P, Huang W. CYFRA21-1 can predict the sensitivity to chemoradiotherapy of non-small-cell lung carcinoma. Biomarkers. 2010;15:594–601. doi: 10.3109/1354750X.2010.504308. [PubMed] [Cross Ref]
Chen Z, Feng J, Buzin CH, Liu Q, Weiss L, Kernstine K, Somlo G, Sommer SS. Analysis of cancer mutation signatures in blood by a novel ultra-sensitive assay: monitoring of therapy or recurrence in non-metastatic breast cancer. PLoS One. 2009;4:e7220. doi: 10.1371/journal.pone.0007220. [PMC free article] [PubMed] [Cross Ref]
Board RE, Wardley AM, Dixon JM, Armstrong AC, Howell S, Renshaw L, Donald E, Greystoke A, Ranson M, Hughes A, Dive C. Detection of PIK3CA mutations in circulating free DNA in patients with breast cancer. Breast Cancer Res Treat. 2011;120:461–467.
Dobrzycka B, Terlikowski SJ, Mazurek A, Kowalczuk O, Niklinska W, Chyczewski L, Kulikowski M. Circulating free DNA, p53 antibody and mutations of KRAS gene in endometrial cancer. Int J Cancer. 2010;127:612–621. doi: 10.1002/ijc.25077. [PubMed] [Cross Ref]
Liggett T, Melnikov A, Yi QL, Replogle C, Brand R, Kaul K, Talamonti M, Abrams RA, Levenson V. Differential methylation of cell-free circulating DNA among patients with pancreatic cancer versus chronic pancreatitis. Cancer. 2010;116:1674–1680. doi: 10.1002/cncr.24893. [PubMed] [Cross Ref]
Ho AS, Huang X, Cao H, Christman-Skieller C, Bennewith K, Le QT, Koong AC. Circulating miR-210 as a novel hypoxia marker in pancreatic cancer. Transl Oncol. 2003;3:109–113.
Iguchi H, Kosaka N, Ochiya T. Secretory microRNAs as a versatile communication tool. Commun Integr Biol. 2010;3:478–481. doi: 10.4161/cib.3.5.12693. [PMC free article] [PubMed] [Cross Ref]
Zomer A, Vendrig T, Hopmans ES, van Eijndhoven M, Middeldorp JM, Pegtel DM. Exosomes: fit to deliver small RNA. Commun Integr Biol. 2010;3:447–450. doi: 10.4161/cib.3.5.12339. [PMC free article] [PubMed] [Cross Ref]
Orozco AF, Lewis DE. Flow cytometric analysis of circulating microparticles in plasma. Cytometry A. 2010;77:502–514. [PMC free article] [PubMed]
Wu FTH, Stefanini MO, Mac Gabhann F, Kontos CD, Annex BH, Popel AS. A systems biology perspective on sVEGFR1: its biological function, pathogenic role and therapeutic use. J Cell Mol Med. 2010;14:528–552. [PMC free article] [PubMed]
Chouaib S, Kieda C, Benlalam H, Noman MZ, Mami-Chouaib F, Rüegg C. Endothelial cells as key determinants of the tumor microenvironment: interaction with tumor cells, extracellular matrix and immune killer cells. Crit Rev Immunol. 2010;30:529–545. [PubMed]
Taylor DD, Gercel-Taylor C, Parker LP. Patient-derived tumor-reactive antibodies as diagnostic markers for ovarian cancer. Gynecol Oncol. 2009;115:112–120. doi: 10.1016/j.ygyno.2009.06.031. [PMC free article] [PubMed] [Cross Ref]
Nakagawa T, Martinez SR, Goto Y, Koyanagi K, Kitago M, Shingai T, Elashoff DA, Ye X, Singer FR, Giuliano AE, Hoon DSB. Detection of circulating tumor cells in early-stage breast cancer metastasis to axillary lymph nodes. Clin Cancer Res. 2007;13:4105–4110. doi: 10.1158/1078-0432.CCR-07-0419. [PubMed] [Cross Ref]
Diehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating mutant DNA to assess tumor dynamics. Nat Med. 2008;14:985–990. doi: 10.1038/nm.1789. [PMC free article] [PubMed] [Cross Ref]
Sunami E, Vu AT, Nguyen SL, Giuliano AE, Hoon DSB. Quantification of LINE1 in circulating DNA as a molecular biomarker of breast cancer. Ann N Y Acad Sci. 2008;1137:171–174. doi: 10.1196/annals.1448.011. [PubMed] [Cross Ref]
Moreira VG, Prieto B, Rodríguez JS, Alvarez FV. Usefulness of cell-free plasma DNA, procalcitonin and C-reactive protein as markers of infection in febrile patients. Ann Clin Biochem. 2010;47:253–258. doi: 10.1258/acb.2010.009173. [PubMed] [Cross Ref]
Zhong XY, von Mühlenen I, Li Y, Kang A, Gupta AK, Tyndall A, Holzgreve W, Hahn S, Hasler P. Increased concentrations of antibody-bound circulatory cell-free DNA in rheumatoid arthritis. Clin Chem. 2007;53:1609–1614. doi: 10.1373/clinchem.2006.084509. [PubMed] [Cross Ref]
Glasziou PP, Irwig L, Heritier S, Simes RJ, Tonkin A. LIPID Study Investigators. Monitoring cholesterol levels: measurement error or true change? Ann Intern Med. 2008;148:656–661. [PubMed]
Künzli BM, Friess H, Shrikhande SV. Is laparoscopic colorectal cancer surgery equal to open surgery? An evidence based perspective. World J Gastrointest Surg. 2010;2:101–108. doi: 10.4240/wjgs.v2.i4.101. [PMC free article] [PubMed] [Cross Ref]
Green S, Tawil A, Barr H, Bennett C, Bhandari P, Decaestecker J, Ragunath K, Singh R, Jankowski J. Surgery versus radical endotherapies for early cancer and high grade dysplasia in Barrett's oesophagus. Cochrane Database Syst Rev. 2009;2:CD007334. [PubMed]
Hoff G, Dominitz JA. Contrasting US and European approaches to colorectal cancer screening: which is best? Gut. 2010;59:407–414. doi: 10.1136/gut.2009.192948. [PubMed] [Cross Ref]
Gøtzsche PC, Nielsen M. Screening for breast cancer with mammography. Cochrane Database Syst Rev. 2011;1:CD001877. [PubMed]
Moore RG, McMeekin DS, Brown AK, DiSilvestro P, Miller MC, Allard WJ, Gajewski W, Kurman R, Bast RC Jr, Skates SJ. A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009;112:40–46. doi: 10.1016/j.ygyno.2008.08.031. [PubMed] [Cross Ref]
Pirmohamed M. Acceptance of biomarker-based tests for application in clinical practice: criteria and obstacles. Clin Pharmacol Ther. 2010;88:862–866. doi: 10.1038/clpt.2010.245. [PubMed] [Cross Ref]
Articles from BMC Cancer are provided here courtesy of
BioMed Central
PubMed articles by these authors
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3285105/
Improved blood tests for cancer screening: general or specific?
BMC Cancer. 2011 Nov 30;11:499.
Diagnosis of cancer at an early stage leads to improved survival. However, most current blood tests detect single biomarkers that are of limited suitability for screening, and existing screening programmes look only for cancers of one particular type. A new approach is needed. Recent developments suggest the possibility of blood-based screening for multiple tumour types. It may be feasible to develop a high-sensitivity general screen for cancer using multiple proteins and nucleic acids present in the blood of cancer patients, based on the biological characteristics of cancer. Positive samples in the general screen would be submitted automatically for secondary screening using tests to help define the likelihood of cancer and provide some indication of its type. Only those at high risk would be referred for further clinical assessment to permit early treatment and mitigate potential overdiagnosis. While the assays required for each step exist, they have not been used in this way. Recent experience of screening for breast, cervical and ovarian cancers suggest that there is likely to be widespread acceptance of such a strategy.
PMID: 22128772 [PubMed - in process] PMCID: PMC3285105 Free PMC Article
http://www.ncbi.nlm.nih.gov/pubmed/22128772
Well Gold at least you responded.
You say 3?
First off, I count 15 categories that CEA picks up on other than Colon cancer. These categories can be broken down into many more subsets when you get right down to it!
Gold stated, "The greater number of cancer types testing positive for a marker make that marker less useful."
WOW I will remember this post Gold and remind you of it from time to time !!!
It is interesting you chose (CEA) such a massive selling Universal CANCER Marker to attempt to voice your opinion.
You also stated,"If CEA only tested positive for colon cancer, don't you think it would have a lot more value than it does today?"
My answer is NO !
Gold that purely depends on what type of cancer one has...
If it were the case that CEA only tested positive for colon cancer then a whole lot of colon / rectum cancer patients would say it had some value except for the issues such as the smoking, infections, inflammatory bowel disease, pancreatitis, cirrhosis of the liver, and some benign tumors that it picks up on that are not necessarily cancer related. However the millions of people suffering from pancreas, stomach, breast, lung, and certain types of thyroid and ovarian cancer would not agree with you! They rely on this CEA test as well
It is very alarming to me that you would refere to those other cancer sufferers and their healthcare professionals as blithering idiots for cancers such as pancreas, stomach, breast, lung, and certain types of thyroid and ovarian cancer were CEA is used alone or in conjunction with other tests to monitor the status of treatment.
In fact they have used and are currently using CEA to monitor my mothers' ovarian cancer.
Your response Gold is very telling in the respect that new Colon cancers in 2012 are estimated to be 227,000 when the others you would like CEA not to be useful for measure much greater than the colon cancer stats. The others are estimated to net 349,000 new cases this year. These are the so called BLITHERING IDIOTS I assume you are refering to?
The most frequent cancer which causes an increased CEA is cancer of the colon and rectum. Others include cancers of the pancreas, stomach, breast, lung, and certain types of thyroid and ovarian cancer. Benign conditions which can elevate CEA include smoking, infections, inflammatory bowel disease, pancreatitis, cirrhosis of the liver, and some benign tumors in the same organs in which an elevated CEA indicates cancer.
Elevated levels of CEA are also found with other types of cancer including pancreatic, gastric, lung, ovary, and breast. CEA is produced during fetal development and if generally not present in most healthy adults.
The CEA blood test is used to detect these types of cancer and levels are often used to monitor the progress of individuals diagnosed with these types of cancer. There are also cases in which CEA is found, but cancer is not present. Benign conditions such as chronic lung disease, cirrhosis, inflammatory bowel disease, and pancreatitis may cause elevated levels of CEA.
http://www.bloodtest.org/pages/blood-test-info-test-list-by-category-cancer-screening-tests-cea-blood-test
http://www.cancer.gov/cancertopics/types/commoncancers
Gold, I gave you the opportunity but you chose not to respond again.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=73932818
So Gold....this is the Billion dollar question to you.
The healthcare diagnostics market is buoyant, reaching $42 billion in 2009 and predicted to grow to
$69 billion in 2014.
The largest market segment is immunodiagnostics at $12.8 billion, which is the main sector which OCB operates within.
The biomarker market is forecast to grow to around $21.2 billion by 2012, from just over $5.4 billion in 2005.
In 2007, the cancer biomarker market accounted for 55% of biomarker revenues, at over $3 billion.
OCB is well positioned to exploit the growing market in companion biomarker diagnostics through its proprietary platforms, know-how and rapid route to market.
Every piece of news from Biocurex as well as the papers published say that Recaf outperforms the other leading biomarkers that are used Worldwide!
So Gold Recaf is reported to perform better than all of the other highly used universal cancer markers.
Especially as a companion test it outperforms the other markers. We now have independent papers verifying that Recaf outperforms currently used universal markers.
The PSA, CEA, CA 15-3, CA-125 are all universal markers and are huge cash cows selling in the BILLIONS with an undeniable market....and yet Recaf outperforms them....and yet you state that Recaf is not useful?
Please explain?
Gold it is interesting that Radients' poor test in your words, has a revenue of over $300,000 per year. That is 46 times the revenue of BioCurex.
That tells me that with some added effort, Biocurex should be able to take $300,000 dollars more in market share.
Thanks Gold.
Ok Gold, We will leave your poor investments alone for now.
I do wish that you would begin to think outside of short term thoughs. Your reference is only focussing on one product stream for the company.
Regarding Radiant, that was you that promoted them. I warned you that they had a very poor product and that they should have been providing a blood clot test in lieu of a so called cancer screening / follow up tests.
Instead of listening to me you kept attempting to compare Biocurex to Radient. Can't help you there Gold....
Dr. Burger is still with the company. Did anyone tell you differently? If so please post the information on this board for everyone to see.
Gold, You definition of death spiral matches that of the US Government financing. There is no way the Government could ever pay off a 150 trillion dollar deficit and yet people continue to purchase treasuries and you continue to invest in the US government every day.
Regarding Biocurex on the other hand...Biocurex has issued stock in exchange for green dollars. This function of raising money is not unlike many other companies. When Biocurex sells its main product they have a better than average chance of wiping out any and all monies the company has spent to date.
Ultimately Biocurex like any other company has to sell its product or other valuable items to show a profit.
They have not yet reached this tipping point, but they will.
In the mean time, you enjoy beating them over the head for their method of financing and yet you as an American citizen have performed far worse in your investments than they have or ever could...
My post was in response to a Goldseeker post showing that his so called factual words were nothing more than his opinion.
Your current request was not discussed in his post.
Genome Sequencing Isn’t Predictive of Most Diseases, Study Says
By Ryan Flinn - Apr 2, 2012 4:45 PM ET
Sequencing the genomes of patients to reveal what ailments might mar their futures isn’t the best predictor for the most common diseases, according to a study involving thousands of identical twins.
Researchers found that most people would get negative results from having their genome sequenced for all but one of 24 identified conditions that includes heart disease, diabetes and Alzheimer’s. While the process can help spot many rare genetic disorders, it doesn’t appear to be a good predictor of who will suffer from the majority of illnesses, the authors wrote.
The key to preventing illnesses remains early prevention strategies, wrote Bert Vogelstein, a study author and professor at the Johns Hopkins Kimmel Cancer Center in Baltimore. Eric Topol, director of Scripps Translational Science Institute in La Jolla, California, said the results show sequencing is still at a very early stage.
“Before we abandon the importance of the DNA sequence, let’s get more data from large populations,” Topol, who wasn’t involved with the research, said in a telephone interview. “This is a moving target, this is a dynamic field.” .
Once millions of people have had their genomes sequenced, scientists may have a better idea about the likelihood of developing any number of disparate diseases, Topol said.
The study was published today in the journal Science Translational Medicine. It didn’t sequence individuals. Instead, researchers collected data from thousands of identical twins in five countries and used a computer model to determine the effectiveness of whole genome sequencing.
No Different Risk
The data suggested that the twins face no substantially different risk of getting the common diseases than the general public. They did find a difference with one disease: Alzheimer’s. In that case, only 12 percent of those with negative readings in their gene sequencing would be likely to develop the condition, according to the study.
Translating an entire human genome required more than a decade of research and billions of dollars by the government’s Human Genome Project, which completed the first sequence in 2003.
Now, Oxford Nanopore Technologies Ltd. plans to sell a genome sequencer the size of a USB memory stick for $900 by the end of this year and companies including Life Technologies Corp. (LIFE) and Illumina Inc. (ILMN) promise genomes sequenced in a day.
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Gold, You never like to answer the tough questions do you...
So Gold....this is the Billion dollar question to you.
The healthcare diagnostics market is buoyant, reaching $42 billion in 2009 and predicted to grow to
$69 billion in 2014.
The largest market segment is immunodiagnostics at $12.8 billion, which is the main sector which OCB operates within.
The biomarker market is forecast to grow to around $21.2 billion by 2012, from just over $5.4 billion in 2005.
In 2007, the cancer biomarker market accounted for 55% of biomarker revenues, at over $3 billion.
OCB is well positioned to exploit the growing market in companion biomarker diagnostics through its proprietary platforms, know-how and rapid route to market.
Every piece of news from Biocurex as well as the papers published say that Recaf outperforms the other leading biomarkers that are used Worldwide!
So Gold Recaf is reported to perform better than all of the other highly used universal cancer markers.
Especially as a companion test it outperforms the other markers. We now have independent papers verifying that Recaf outperforms currently used universal markers.
The PSA, CEA, CA 15-3, CA-125 are all universal markers and are huge cash cows selling in the BILLIONS with an undeniable market....and yet Recaf outperforms them....and yet you state that Recaf is not useful?
Please explain?
The cancer biomarker market represents one of the largest segments of biomarkers in terms of revenue. In 2007, the estimated cancer biomarker market accounted for around 55% of biomarker revenues at over US$3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics.
This market is relatively mature due to researchers’ comprehensive understanding of the underlying genetic and proteomic components of the disease. It has been the focus for the majority of the early biomarker research which was aimed at the discovery and identification of biomarkers that guided the development of targeted therapies (companion diagnostics) and has been stimulated by advances in technology platforms for the analysis of biological samples (blood, serum and tissue).
Collaborative working is essential
During the last two years, the leading pharma companies such as Abbott, AstraZeneca, Eisai, Merck & Co, sanofi-aventis, Solvay, Pfizer, Roche and Wyeth have been forming strategic alliances with a variety of companies, including Caprion Proteomics, Celera, Epigenomics, EpiStem, Monogram BioSciences (formerly ViroLogic) and Vermillion which are all actively involved in biomarker discovery and validation.
Many of these agreements have been established in the last 12 months and pursue the identification of multiple oncology biomarkers that complement pharma product pipelines. For example, in March 2008 Abbott established a collaboration with Genentech, Roche and OSI to develop an EGFR FISH based test for NSCLC testing. Similarly, specialty pharma companies such as Amgen, Myriad and OSI Pharmaceuticals have formed collaborations to utilise biomarkers in drug discovery and development programmes.
Increasingly, the industry is establishing relationships with leading academic institutes to clinically validate biomarkers prior to their use in clinical drug development programmes. For example, in the US, the Eastern Virginia Medical School, the Johns Hopkins University, The University of Kentucky, the Mayo Clinic, and the MD Anderson Cancer Center and, in Europe, the Institut Curie in France and the University of Oxford in the UK are all assessing new cancer biomarkers and technology platforms for biomarker discovery and validation.
So Gold Recaf is reported to perform better than all of the other highly used universal cancer markers.
Especially as a companion test it outperforms the other markers.
So in your OPINION then why is it not useful?
Yep. Remember when you were convinced no other Universal Markers existed? I would say we are in pretty good company being listed as a Universal Cancer Marker...Wouldn't you?
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67676686&txt2find=universal
Gold, Here is a list of some other Universal cancer markers that have done very well in the market.
It just may be that Recaf should be compared to these as equal or better wouldn't you say?
CA 15-3 can be elevated in malignancies other than breast cancer, including lung, pancreatic, ovarian, liver, and colorectal cancers.
The most frequent cancer which causes an increased CEA is cancer of the colon and rectum. Others include cancers of the pancreas, stomach, breast, lung, and certain types of thyroid and ovarian cancer. Benign conditions which can elevate CEA include smoking, infections, inflammatory bowel disease, pancreatitis, cirrhosis of the liver, and some benign tumors in the same organs in which an elevated CEA indicates cancer.
CA-125...70% of people with cirrhosis, 60% of people with pancreatic cancer, and 20%-25% of people with other malignancies have elevated levels of CA-125.
Conditions that could lead to an elevated PSA level in men who don't have prostate cancer include:
Benign prostate enlargement (benign prostatic hyperplasia)
A prostate infection (prostatitis)
Other less common conditions
Gold posted, it is getting pretty drastic at Biocurex.
Gold you have continually and purposefully painted only two potential paths for Biocurex and have incorrectly forecasted its demise for many years.
One of your paths leads to despair and utter hopelessness. The other to total extinction.
Thankfully you are not running the company.
Breaking the post down to the so called opinion vs. so the so called facts.
You say Biocurex would have been long gone if Moro had not found Burger.
This is obviously your opinion as well as false.
Biocurex has sustained themselves for many years absent Dr. Burger.
Obviously Dr. burger contributed to Biocurex and apparently liked what he saw as did the others that invested in the company.
"burger single handedly got more money for them"
Again this your opinion as well as false.
There were many investors that provided additional funds to Biocurex.
"now it is back to square 1 with no significant revenue or money
Again your opinion and again incorrect.
Square 1 was established many years ago back in the day that Biocurex had no papers published and no marketable products. We are very far removed from your purported so called square 1 Gold.
This time there is no white knight to rescue and all there is left is Toxic financing.
Again your opinion and again incorrect.
You assume that Dr. Burger is / was the last white knight on this planet? Wow now that is pretty bold opinion!
Was he the last knight on earth and have they stopped making knights? I think not Gold.
There is no backing away from the toxic......
Wow another strong opinion but again incorrect
Your statement is without logic here Gold...it is only your opinion that again has been incorrect so many times in the past regarding this matter but I feel compelled to correct you again for the sake of the rest of the board.
According to you the world is flat and once one sails past your asserted boundary they fall off the world into dead space. Sorry Gold but the world is not flat as you would make it out to be.
Your intended scary words such as toxic and death spiral and out of this and out of that continue to be incorrect.
In December Smithline yotta yotta end of the world....
Gold this again is unsubstantiated and is also contrary to what you have been recently stating.
It is difficult to remember where you stand in your opinions. Is It that Smitty is going to own the shop or is it that Pacific Biosciences will run with one or both of the websites that Dr. Moro secretly set up in his Frankenstein laboratory. Remember your opinion stating that successful or non-successfully in your opinion Dr. Moro will take the Recaf potion for himself and screw everyone else and own the world while the shareholders are shunned and yotta yotta....
I did not find any factual parts in your post..