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Voluntary Exploratory Data Submissions (VXDS)
Voluntary Exploratory Data Submissions (VXDSs) are a novel way to share information with the FDA. The VXDS program is a non-regulatory, flexible mechanism for scientific exchange between FDA and external scientists (e.g., industry scientists, academic researchers). While the VXDS program originated and is operated out of Center for Drug Evaluation and Research (CDER), scientists from other FDA Centers are included in Interdisciplinary Scientific Exchange Groups (ISEGs). Unique ISEGs may be formed for each VXDS to allow for exchange with appropriate content experts.
FDA and submitters of VXDSs alike would benefit from an enhanced understanding of relevant scientific issues of potential relevance to public health or therapeutic product development. The scope of VXDS meetings includes (but is not limited to) scientific discussions of:
Complex diseases biology
Determinants of drug response
Biomarkers
(Pharmaco)genetics/genomics
Drug discovery and development
Innovations in trial designs and methodology
Emerging technology
Informatics
A greater understanding of the state of the art, issues, and challenges in the above areas may ultimately enhance therapeutic product development and/or advance regulatory science and policy.
Submitters of VXDSs benefit in the following ways:
Opportunity for flexible, scientific, non-regulatory meetings with FDA experts
Opportunity to gain insight into current FDA thinking about exploratory data that may assist in reaching important strategic decisions
For drug developers, potential time-savings by familiarizing FDA early with novel exploratory data prior to regulatory submission (e.g., NDA or BLA)
Opportunity to bring to FDA important issues that may inform future standards, policies, and guidances
For more information, contact Issam.Zineh@fda.hhs.gov
Gold, I am not sure of your purpose in posting this but, we could have sure used this in my family as a screening test some time ago.
The most recent (today) news is that the "SLOW GROWING" Ovarian Cancer that was found in stage (III / IV) has grown from 2 cm to 6 cm in only a few months. We have had two each $10,000 dollar CAT scans that show the size and location of the confirmed cancer.
The Doc called it slow growing and still continues to call it slow growing. The term Slow Growing means squat in real life!!
Now one looks at revisiting Chemo or quality of life or both or niether. Operating a second time is not possible as part of the liver was already removed last time.
Further, an early diagnosis would have allowed the doc to remove the Ovaries and be done....This particular instance in stage III / IV has allowed the cancer to overtake the Colon and Liver and other areas.
I look forward to Recaf being used as a companion diagnostic as this same story is repeated thousands of times per year. If we could have only found it earlier....
Combination of CA125 and RECAF biomarkers for early
detection of ovarian cancer
Ovarian cancer can be cured in up to 90% of cases if
diagnosed early. CA125, the most studied ovarian cancer
biomarker, exhibits poor sensitivity for detecting early disease
stages and low specificity to malignancy. RECAF, the alphafetoprotein
receptor, is a wide-spectrum oncofetal antigen with
clinical potential for cancer diagnosis, screening, and monitoring.
This study evaluated the performance of RECAF as a
diagnostic tool and the sensitivity of a combination of RECAF
and CA125 to detect early stages of ovarian cancer at a cutoff
resulting in 100% specificity among healthy women
Gold, I remember when you said you were no longer going to post on this board.
You then changed your mind. Does a company the size of Abbott also have the ability to change their mind?
I would then also assume that Abbott has the right to look at a new improved test and the fact that they can present a new and improved test to cover the black eye that the PSA test has received recently.
In a previous announcement, BioCurex compared the performance of RECAF and free-PSA to discriminate prostate cancer from benign prostate hyperplasia (BPH), a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies. (BioCurex's RECAFTM Blood Test for Cancer Can Prevent Two Thirds of Unnecessary Prostate Biopsies Sep 8th, 2011).
The INTENDED USE in the submission reads: "The serum-RECAFTM CLIA test is an in-vitro device for the quantitative measurement of RECAF (receptor for Alpha-fetoprotein) in human serum. The RECAF test is intended to be used in men aged 50 years or older with total PSA values between 4-10 ng/ml and non-suspicious DRE. The RECAF value can be used as an aid in discriminating between prostate cancer and benign disease. Prostatic biopsy is required for the diagnosis of cancer".
Dr. Ricardo Moro, CEO of BioCurex, stated, "This pre-IDE submission is the first step toward seeking FDA approval of our RECAFTM test. This process is aimed at avoiding errors and detours on behalf of the applicants and therefore, should help to speed the regulatory process."
According to the FDA, the pre-IDE process can be thought of as a "pre-submission" process. It may involve sending analytical or clinical protocols to FDA for review and comment before proceeding with studies. The process may also involve a meeting with FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. In fact, most in vitro diagnostic devices (IVDs) are exempt from the medical device IDE regulations as long as conditions in 21 CFR 812.2(c)(3) are met.
http://www.canaryfoundation.org/publications/pre-IDE%20integrated%20v03%20030421.pdf ; http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm123682.htm#4b and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#pre_ide)
So Gold,
If it were you, which predicate would you use for say, Breast, Prostate, Colon, and Ovarian cancers?
gold stated,"The fact is that a predicate device is needed for a 510k application that is approved for a similar test as RECAF"
Currently, there are only nine protein cancer biomarkers that have been approved by the FDA for clinical use (see Table 1).6 These protein markers include a-fetoprotein (AFP) for staging of non-seminomatous testicular cancer and monitoring of hepatocellular carcinoma; cancer antigen-125 (CA-125); and human epididymis protein 4 (HE4) for monitoring of ovarian cancer; thyroglobulin (Tg) for monitoring of thyroid cancer; prostate specific antigen (PSA) for screening and monitoring of prostate cancer, carcinogenic embryonic antigen (CEA) for monitoring of pancreatic cancer; and CA15-3/CA27-29 and HER2/neu for monitoring of breast cancer.6
And who sells a boat load of PSA tests that this combination would be used with?
Gold stated,"Question: Do you know what an IDE even is? "
I wanted to ask you that same question...
Gold stated,"Moro is actully looking to exempt RECAF from FDA regulations when used in conjunction with PSA. "
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67788785
FDA-approved protein biomarkers for cancer
Currently, there are only nine protein cancer biomarkers that have been approved by the FDA for clinical use (see Table 1).6 These protein markers include a-fetoprotein (AFP) for staging of non-seminomatous testicular cancer and monitoring of hepatocellular carcinoma; cancer antigen-125 (CA-125); and human epididymis protein 4 (HE4) for monitoring of ovarian cancer; thyroglobulin (Tg) for monitoring of thyroid cancer; prostate specific antigen (PSA) for screening and monitoring of prostate cancer, carcinogenic embryonic antigen (CEA) for monitoring of pancreatic cancer; and CA15-3/CA27-29 and HER2/neu for monitoring of breast cancer.6
AFP:This single-chain glycoprotein is produced by the liver and is a major serum protein in the fetus. Following birth, the concentrations of AFP decrease rapidly until only trace amounts are detectable by the second year of life.10 Several studies have shown a direct correlation between elevated AFP levels (>5 U/mL) in non-seminomatous germ-cell tumors (NSGCTs) and disease stage,11 making this protein a useful biomarker in cancer staging. AFP concentrations are also increased in patients with hepatocellular carcinoma (HCC), as persistently elevated levels are indicative of residual disease, while rising levels are suggestive of disease progression or recurrence.12 The sensitivity and specificity of AFP as a biomarker is relatively low; for HCC, sensitivity is 50%, while specificity is 70%.13 In addition to NSGCTs and HCC, however, elevated AFP-serum levels are also associated with pregnancy, primary hepatocellular carcinoma, endodermal sinus tumors, and diseases such as ataxia telangiectasia, acute viral hepatitis, and cirrhosis.
CA-125:A member of the glycoprotein family, this protein has been clinically approved for following the response to treatment, predicting prognosis after treatment, and for detecting the recurrence of ovarian cancer. While this protein has been approved as a biomarker for ovarian cancer, it is important to note that increased serum concentrations (>21 U/mL)14 have also been observed in relatively benign conditions, such as endometriosis as well as other malignant cancers — especially those originating in the endometrium, fallopian tubes, lungs, and breast. Thus, utilization of this protein does not demonstrate the clinical sensitivity and specificity required for ovarian-cancer screening.
HE4:As the most recently FDA-approved biomarker, HE4 is recommended for the use of monitoring patients for recurrence of epithelial ovarian cancer. Disease recurrence or progression is often indicated by HE4 levels ³150.1 pM.15 Similar to CA-125, however, elevated levels of HE4 are not solely associated with ovarian cancer, making it non-specific and not suitable for use in diagnosis of or screening for ovarian cancer.
Tg: Tg is a protein produced and used solely by the thyroid gland, and levels in the blood can be measured and used as a tumor marker for monitoring certain types of thyroid cancer. Tg tests are commonly ordered prior to surgical removal of the thyroid gland for cancer to determine whether or not the tumor is producing Tg. Following tumor resection, Tg should be undetectable or very low; measurable levels in the blood may indicate cancerous tissue remaining in the body (incomplete resection) and the need for additional treatment. Tg lab tests can be ordered at regular intervals to monitor for cancer recurrence as rising levels over time following surgery may be indicative of cancer recurrence. In addition to serving as a marker for thyroid cancer, Tg levels are also elevated in persons with Graves’ disease16 and thyroiditis.17
PSA:Serum PSA is typically present at relatively low levels in men, and increased levels of this protein can be indicative of prostate cancer. While the majority of PSA in the blood is bound to serum proteins, a small portion referred to as free PSA is not. Comparison of free PSA to PSA levels is used to assess the risk of cancer, as the ratio of free PSA to PSA in prostate cancer is decreased. Elevated levels of PSA can also be attributed to prostate infection, irritation, benign prostatic hypertrophy, or recent ejaculation. Thus, tests for PSA show neither the specificity nor the sensitivity required for prostate-cancer screening. Nonetheless, despite this controversy, PSA screening continues to be recommended for men over the age of 50 years.
CEA: CEA is a glycoprotein involved in cell adhesion that is normally produced during fetal development. Production of the protein ceases prior to birth and is, therefore, not typically present in the blood of healthy adults. Elevated levels of CEA (>2.5 ng/mL)18 are most commonly used as a biomarker for monitoring of colon cancer following tumor resection and for monitoring the response of metastatic colorectal cancer to systemic therapy. While FDA approved for these applications, elevated CEA levels are also associated with these carcinomas — colorectal, gastric, pancreatic, lung, and breast — making it an unreliable biomarker for cancer diagnosis or early cancer detection.19
CA19-9:This glycoprotein is used to monitor pancreatic-cancer patients’ responses to therapy. While low levels of CA19-9 are detectable in the blood of healthy individuals (=37 U/mL),20 significantly elevated levels (>37 U/mL)20 have been observed in patients with pancreatic cancer. Thus, in cases where the cancer is producing elevated levels of CA19-9, routine tests may be ordered as fluctuations in levels can be used to monitor treatment and help detect recurrence. Because elevated levels of CA19-9 have also been correlated with bile duct, gastric, and colon cancers, as well as with non-malignant conditions such as pancreatitis and cystic fibrosis, this tumor marker does not exhibit the specificity to be used for diagnosis or in population screening.
CA15-3/CA27-29:Approved as a biomarker for breast cancer, a high CA15-3 level (>32 U/mL)21 typically indicates advanced breast cancer and a larger tumor burden. CA15-3 is used in combination with diagnostic imaging, patient history, and physical examination during active cancer therapy to monitor metastatis. Due to its lack of sensitivity and specificity, this marker has only been FDA approved for monitoring a patient’s response to breast-cancer treatment and recurrence.
HER2/neu:HER2/neu is encoded by an oncogene, is over expressed in 15% to 20% of invasive breast cancers, and is associated with increased tumor aggressiveness and reduced survival rates.22 Trastuzumab (Herceptin) is a humanized monoclonal antibody that targets HER2/neu and is used in combination with cytotoxic chemotherapy to treat patients with tumors that show over expression of this gene.23 Thus, HER2/neu serves as a predictive biomarker to assess tumor susceptibility to trastuzumab and other HER2/neu-targeted therapies such as lapatinib.24
Additional candidate cancer biomarkers
Although there are only nine FDA-approved blood biomarkers for cancer, the list of potential candidates continues to grow. Vascular endothelial growth factor A (VEGF-A) is a protein having greater than 500 citations in the scientific literature as a potential biomarker,1 and increased serum levels have been associated with melanoma, pituitary, breast, and colorectal carcinomas.1 Calcitonin, a second protein with greater than 500 citations, is a peptide hormone produced by the thyroid that acts to oppose effects of parathyroid hormone (PTH), thereby lowering blood calcium and phosphate levels.1 Levels of calcitonin are often used to aid in the diagnosis of thyroid cancer, to determine cancer- treatment effectiveness, and to monitor patients for recurrence of thyroid tumors.25 Similar to other candidate biomarkers, however, calcitonin lacks the specificity required to be used for diagnosis as elevated levels are also observed in Hashimoto’s thyroiditis.25 Other candidate biomarkers that have >500 citations include gastrin (a hormone associated with gastric and colorectal cancer)26; chromogranin A (CgA), secretory protein associated with neuroendocrine tumors and decreased survival in small cell-lung cancer27; von Willebrand Factor (VWF), coagulation factor showing elevated levels in colorectal cancer patients28; and tumor necrosis factor-a (TNF-a), a pro-inflammatory protein observed in 36.5% of pancreatic-cancer patients.29
Additional blood-based proteins that are well cited in the literature as potential cancer biomarkers include haptoglobin-1 (increased in leukemia patients and associated with poor prognosis in small cell lung cancer); a-2-macroglobulin (a2M), a plasma proteinase inhibitor showing decreased expression in prostate cancer metastases30; and angiopoietin-1 and -2 (Ang-1, Ang-2), increased levels have been observed in breast cancer.31
Requirements for clinically applicable biomarkers
To be approved as a clinically useful biomarker, several conditions should be considered. First, to be effective for early diagnosis, the potential biomarker must be a molecule that is released into circulation at a detectable concentration by a small asymptomatic tumor.32 Thus far, such molecules have eluded researchers as the majority of biomarkers currently used are only sufficient to detect late-stage tumors, and, therefore, are useful only for disease staging and monitoring. Next, in order to distinguish normal from diseased samples, the biomarker should be highly specific for the tissue of origin, as expression in additional tissues means a high level of expression in normal healthy individuals. In addition, there must be sufficient biomarker released from the diseased tissue to be detectable over other highly expressed background proteins, which likely requires larger tumors.33 An additional caveat to biomarker utility is the need to identify molecules that are not affected in non-cancerous tissue.33 To date, however, no single molecule has been identified that is expressed only by cancer tissue, with the possible exception of those that have variations in post-translational modifications, such as pancreatic ribonuclease in pancreatic adenocarcinoma and kallikrein 6 observed in ovarian cancer.33
Gold stated,"there are no other cancer marker tests that are FDA cleared to monitor any other cancers so if Moro was looking to monitor other cancers, it would be a PMA for each type. "
Are you serious?
There are many biomarkers approved to monitor cancer !
ABBOTT PARK, Ill., June 3 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) has cleared a new diagnostic test to monitor ovarian cancer, a disease that will strike an estimated one out of every 71 women in the United States in their lifetimes. Abbott's new ARCHITECT HE4 (human epididymis protein 4) assay, the first automated test of its kind available in the United States, uses a simple blood test to aid in monitoring for the recurrence or progression of this disease.
http://www.prnewswire.com/news-releases/abbott-receives-fda-clearance-for-new-ovarian-cancer-test-95501934.html
CA 15-3 and CA27.29 are used in combination with other testing to aid physicians in following the course of cancer in patients. They have been approved for monitoring the response to therapy and to monitor for recurrence of disease in patients diagnosed with breast cancer
What about the PSA test? Do you think that PSA is not used to monitor cancer?
Dog stated, "Is"nt the 60 day FDA timeline Dec 7th?"
Wouldn't it be fitting to prove the Naysayers incorrect on the anniversary of Perl Harbor...Dec 7th
Dog, I am very interested in their response!
I anticipate a GREEN light. A yes nod from the FDA should open a lot of eyes!
Abbott Laboratories and Inverness License Agreements
• RECAF has been validated by data and licenses to Abbott Laboratories and Inverness Medical Innovations.
• Abbott sells 15 million PSA tests per year. With a minimum royalty of $2 per test if RECAF was sold in
combination with PSA tests, the royalty revenue to BioCurex would be significant with no associated costs to
BioCurex.
• If Abbott sold RECAF tests for breast, ovarian and cervical cancers, the royalty revenue to BioCurex could
significantly increase.
• Inverness has about 5,000 instruments installed worldwide that could accommodate the RECAF test. With a
minimum royalty of $2 per test, the royalty revenue to BioCurex could be significant when sold for cancer screening.
Milestones and Goals
• Finish contracted development of point-of-care rapid tests.
• Run clinical trials for FDA submission and CLIA waiver and submit
application for FDA marketing clearance.
• Sign partner agreement for third semi-exclusive licensee for automated testing format.
• Sign agreement for development and complete manufacturing for Abbott formatted automated tests.
• Complete veterinarian partnership and market products.
• Submit additional patent protecting new key findings surrounding the
technology.
• Develop second generation tests using these new key developments and out- license new technologies.
• Become revenue generating and cash flow positive from:
- veterinarian applications, non-automated lab testing.
- royalty stream, licensing deals, out-licensing of new patented technologies.
Tentacle, like most small biotech companies, Biocurex has been a news driven company. Good news drives the price up, infrequent or misunderstood news let's it drift back down. At some point however the news curve and the earnings curve meet...IMO this is where we are at.
Studies with favorable results are good but the market is starving for positive sales results or at least the hint of sustainable upcoming positive earnings.
There are many irons in the fire.
A positive result from the FDA would surely move the stock.
The recent Webster announcement was met with a snore, But...I do believe it was a bigger achievement than the market understood. Looks like it is going to be a wait and see. If sales numbers come in favorable, we will see a significant uptick.
Obviously a third license would also move the stock.
Also, it will be interesting to see the upcoming published data that was recently discussed.
The science works! The demand for a better test exists! We now need to get this test in the right hands. A company who is politically as well as sales savvy to turn it into sales.
Why is it so hard to find a test to predict cancer?
Lizzie Buchen
Two studies appeared online that offered 19 pages of gloomy reading for anyone interested in cancer. They focused on biological molecules, or biomarkers, the presence of which in the blood might be used to detect the earliest glimmers of ovarian cancer — a disease not normally discovered until it has destroyed the ovaries and rotted other parts of the body. The researchers, coordinated by the Early Detection Research Network (EDRN) of the US National Cancer Institute (NCI), had assembled 35 protein biomarkers, including 5 panels of proteins, that had looked the most promising in early studies. They had carried out rigorous testing — screening blood samples from more than 1,000 women — to ask whether these seemingly breakthrough biomarkers were better at identifying women with early ovarian cancer than the one flawed biomarker that had been in use for almost 30 years, CA-125. None of them was1,2. "CA-125 remains the 'best of a bad lot'," read an accompanying perspective article3. "The new candidates have fallen short of expectations."
Tied in last place for its poor performance among the biomarker panels was one identified by Gil Mor, a cancer biologist at Yale University in New Haven, Connecticut. Mor's six-protein panel detected ovarian cancer in only 34% of the women who were diagnosed with the disease within a year. (CA-125, by contrast, detected 63%.) Mor's panel already had a tortured history. A primary research paper behind it had been criticized by other scientists for allegedly using inappropriate statistical calculations and for optimistically concluding that the test would help women before rigorous follow-up studies proved that it could. Yet for four months in 2008, the test was sold to patients by Laboratory Corporation of America (LabCorp) in Burlington, North Carolina, the company that licensed the panel from Yale. LabCorp had marketed the test under the name OvaSure until the US Food and Drug Administration (FDA) intervened and the company pulled it from the market. The panel offered "invaluable object lessons" for bringing a test prematurely to the clinic, wrote the authors of the perspective article.
“As we're moving up to multiple markers, all our bad habits are coming back to bite us in a big way.”
Similar lessons can be found in the stories behind many cancer biomarkers that have sputtered and failed on their way to the clinic. Those tests that are in clinical use — including prostate-specific antigen (PSA) for prostate cancer, mammogram-detected masses for breast cancer and CA-125 — fail to detect all cancers and sometimes 'detect' ones that aren't there. Genomics, proteomics and other such technologies promised to help by finding combinations of markers that are more powerful and cancer-specific than individual ones, but that promise has not been realized. Researchers using such technologies have published studies on thousands of panels, suggesting that they can detect early-stage disease, guide patient treatment and monitor recurrence. But only a tiny number of such tests have reached the clinic — and none for the early detection of cancer, the biggest clinical challenge of all. "Much biomarker research has been done very badly for decades," believes Lisa McShane, a biostatistician at the NCI in Rockville, Maryland. "Even when it was single markers. Now, as we're moving up to multiple markers, all our bad habits are coming back to bite us in a big way."
These habits have been thrown into the spotlight by the EDRN's study, one of the largest and most systematic validation studies of biomarkers so far. It came just months after a high-profile decision at Duke University in Durham, North Carolina, to suspend clinical trials of a genomics-based biomarker panel designed to direct chemotherapy in patients with breast cancer. A number of scientists had raised concerns about the Duke group's data and analysis, and the trial was stopped after allegations came to light that the lead researcher, geneticist Anil Potti, had made false claims on his CV. Last September, the Institute of Medicine (IOM), part of the US National Academies, assembled a committee to discuss lessons for developing tests based on 'omics' technologies and bringing them to the clinic. "Why don't we have assays out there, with this enormous promise?" Dan Hayes, a breast-cancer researcher at the University of Michigan in Ann Arbor asked researchers at the first IOM committee meeting in December 2010."It's either because these things just don't work, or because we've used sloppy science to test them."
It is too early to say whether either of these is true: the field is still young, and faces many challenges. It has drawn in many cancer biologists who are excited by the potential to translate their work to the clinic — but they sometimes lack the expertise or resources needed to pursue translational or clinical work. "A lot of novices came in. They get in without realizing that the problem may be more complex than it appears," says Eleftherios Diamandis, a clinical biochemist at the University of Toronto in Canada. And although most experts agree that potential biomarkers for early cancer detection should be validated on samples taken before diagnosis — the stage at which the test would be used in the clinic — that is a step that few groups attempt and no biomarker for ovarian cancer has passed, as the EDRN study made clear. "Sometimes the glamour of the technology or the sheer volume of omics data seem to make investigators forget basic scientific principles," said McShane at the IOM meeting. Mor agrees that the field has faced problems, and that it is important for markers to go through a careful process of design and validation, as he tried to do.
"There's been an enormous amount of hype and promise," sums up David Ransohoff, a cancer epidemiologist at the University of North Carolina in Chapel Hill. "But after 10 or 15 years of intense work in these fields, there's simply not a lot to show for it. It's important for the whole field to step back and look at what is wrong."
Making a difference
Mor began his career in Israel, where he trained as a clinician at the Hebrew University of Jerusalem. But an experience in the final years of his oncology residency compelled him to change course. A young woman arrived at the hospital with ovarian cancer, a disease that kills some 140,000 women worldwide each year. The oncology team removed the woman's ovaries and put her through several rounds of chemotherapy, which seemed to be successful. But 18 months later, she was back, her body riddled with tumours, and she soon died. "Chemotherapy didn't do anything for her," Mor recalls. "She was 29. She was a beautiful girl. An impressive girl. A medical student. And I never understood what happened to her."
Mor decided to leave medicine, which had been unable to save her, for research, which one day might. He earned a PhD studying ovarian cancer at the Weizmann Institute of Science in Rehovot, Israel, before moving to Yale in 1997. He went on to start a programme called Discovery to Cure, aiming to speed cancer research to the clinic. The group began to build a bank of blood and tissue samples, including some from a Yale clinic for women with a high risk of ovarian cancer owing to a family history of the disease."There was a lot of excitement around that time for finding proteins specific to cancer," says Mor.
In 2003, David Ward, then a geneticist at Yale, contacted Mor. Ward had co-founded Molecular Staging, a company in New Haven that had developed a 'high-throughput' technique for quantifying multiple proteins in the blood using arrays of antibodies4. He asked whether he could use Mor's samples to search for markers of early ovarian cancer.
Mor had never been involved with biomarker research — "I do biology of cancer, not biomarker development," he says — but he signed up, intrigued by the clinical potential of the technology. Ward had scoured the literature for proteins that had been associated with ovarian-cancer growth and malignancy, and had come up with 169 candidates. Using the protein-quantification technique, Ward's company screened blood samples in Mor's tissue bank that came from two groups: women with newly diagnosed ovarian cancer who had been enrolled in Yale's high-risk clinic, and women who had come to the hospital for routine gynaecological exams. Using additional cancer-patient samples, they whittled the list down to four proteins: leptin, prolactin, osteopontin and insulin-like growth factor II.
Gil Mor is testing whether a panel of six proteins can detect ovarian cancer in women at high risk.
S. OgdenMor worked to develop an algorithm that could automatically classify women as having cancer or not, depending on levels of these four proteins. When the team ran a new set of blood samples through the algorithm, they got astounding results. The test showed a sensitivity of 95% (meaning it correctly detected 95% of the ovarian-cancer cases) and a specificity of 95% (it erroneously classified only 5% of healthy people as having cancer). "I was delighted," says Mor. On equivalent samples, CA-125 tests typically have a sensitivity of 70–80% and a specificity of around 95%. In May 2005, the findings were published in the Proceedings of the National Academy of Sciences (PNAS), with Ward as a contributing author5.
Before publication, Mor helped the Yale Office of Cooperative Research to prepare a patent application. "A lot of companies expressed interest in licensing the panel," says John Puziss, director of technology licensing at Yale. LabCorp licensed the test in 2006, as did Millipore, a biomanufacturing company based in Billerica, Massachusetts. (Mor says that the royalties he and his co-inventors received "were not a significant amount".)
The test's promising results had also caught the attention of researchers in the EDRN, who were just putting together their validation study. Up to that point, most biomarkers for detecting early ovarian cancer had only been shown to distinguish patients with diagnosed cancer from healthy controls, but they are intended to detect the disease in women whose cancer is just budding, before symptoms develop. What the field needed was a 'prospective' study, run on blood samples from apparently healthy women, to see whether the biomarkers could pinpoint those who would later be diagnosed with ovarian cancer. Such samples, from large numbers of women who are tracked over months or years, are extremely difficult to come by.
Problem detection
The EDRN found what was needed in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, sponsored and run by the NCI. Between 1992 and 2001, the trial had been collecting blood at regular intervals from 155,000 women and men, and screening them for cancer. By June 2006, 118 of the women had developed ovarian or closely related cancers, and the EDRN researchers were now in a position to use them to evaluate the most promising biomarkers for early detection. Ziding Feng, a biostatistician at the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle, Washington, and coordinator of the EDRN, visited Mor to discuss whether his panel of four proteins could be included in the study.
“It's important for the whole field to step back and look at what is wrong.”
Mor was already in the process of refining the panel: he had more patient samples, and wanted to add more markers, including CA-125 and the protein macrophage migration inhibitory factor, to make the test more sensitive to cancer. LabCorp had been running his new samples on assay kits manufactured by Millipore. (Ward, meanwhile, had moved to the Nevada Cancer Institute in Las Vegas, and was not involved in data collection or analysis.)
When Mor showed Feng how he was analysing his recent data, Feng was troubled. Mor asked him to go through the new results himself, and Feng agreed to collaborate. "I do not do statistics," says Mor. "That is not my field." The researchers also added the six-protein panel to the EDRN's validation study.
Feng and Gary Longton, another statistician at the FHCRC, developed their own classification algorithms, and found that Mor's test had a sensitivity of 95% and specificity of 99%. They also calculated the positive predictive value (PPV) of the test — the proportion of patients who the test would diagnose with the disease and do in fact have it. A high PPV means that few people will be misdiagnosed, which is crucial when screening healthy people.
Feng and Longton calculated the PPV at 6.5%, too low for the test to be of much use for screening. But separately, Mor was working with a different figure, of 99.3%. The huge disparity between the two values stemmed from the way that they calculated the figure and factored in the prevalence of ovarian cancer — an important variable in calculating the PPV. Following convention, Feng and Longton calculated the PPV using the accepted prevalence in post-menopausal women, 1 in 2,500 (0.04%). But Mor's figure was calculated solely from the study population, in which the prevalence was 46%. "We calculated the PPV based on the population in the study, because we always intended the test for the high-risk population," says Mor. "If you want to bring the test to the clinic, it has to be calculated based on the population you're going to study," he says, noting that other research studies work out the PPV for the study population in this way.
It's a common mistake, believes McShane, who — like other statisticians — disagrees with Mor's logic. "I see that a lot, but it is nowhere near the correct thing to do," she says. Even in high-risk populations — women who are screened every year because of their family history or because they have tested positive for mutations in tumour-suppressor genes BRCA1 or BRCA2 — the prevalence is around 0.5%, far below the 46% in Mor's study population. Similar battles over the correct use of statistics litter the cancer-biomarker field, said researchers at the IOM meeting last year. "It's the type of thing where non-statisticians think statisticians are being uptight about something that's not going to matter anyway," says McShane.
Mor prepared a paper reporting the latest work. But when Feng and Longton saw the page proofs, they noticed that the PPV value was reported as 99.3%. They asked Mor to change it to the 6.5% that they had calculated, and to correct a few other typographical errors in the tables. "He agreed, so we signed off," recalls Feng. But there was a miscommunication: Mor thought that Feng had agreed to the use of the high PPV, and that everyone approved of the final manuscript.
The paper was published online in Clinical Cancer Research6 in February 2008, and to Feng's shock it reported the high PPV. "You can imagine how upset I was when I saw it in the paper," says Feng.
Feng called Mor. "I told him, those are errors, we told you those are not correct." Feng also contacted the journal, the editor of which asked Mor to submit a correction to fix the PPV and the other typos. Mor agreed, adding the lower PPV as a footnote to the table and in a written correction.
A few weeks later, Feng received an e-mail with unwelcome news from a colleague: LabCorp was preparing to market the panel, and was "hopeful that this test will be available to women by the end of the year".
"I was shocked," says Feng. "I had no idea this was coming." He thought that the markers should be validated further before they went to the clinic. In March 2008, Feng and Mor saw each other at a meeting in Washington DC. "I told him, face to face, you cannot do this," says Feng. "You have to wait until after the PLCO validation. What you have done is early discovery. If validation does not support your earlier claim, you're making a significant error." Mor does not recall this encounter, but says that Feng's "role was to analyse the data, not to make judgements of a company decision".
Now, Mor says that if he were preparing the paper again, he would include both the low and high values for the PPV. And he vacillates about whether LabCorp's decision to offer the test to women before it had undergone more validation studies was the right thing to do. He says he thought that clinical use of the test might be a good way to do further validation. "It's very difficult to do that on large numbers of patients," he says. "It's extremely expensive. The only way to do the study is if LabCorp started distributing the test and enrolling patients." Mor notes that many tests, such as mammography, have been offered to patients as an aid to diagnosis even while data on the test are being collected. "Was it the right time? I don't know," he says.
Critical backlash
On 23 June 2008, LabCorp announced the availability of the OvaSure test, for between US$220 and $240. The press release said that it was being offered to women with a high risk of the disease, and quoted Mor as saying he was "pleased that this test is available to help physicians detect and treat ovarian cancer in its earliest stages".
Excited chatter about the test spread through patient forums and support groups, but it was soon countered by cautionary tales. Jean McKibben, an ovarian-cancer survivor, rushed to take OvaSure on the first day it was available, and her results showed a 0.00 chance of cancer. A week later, scans showed that her cancer was back. She was crushed. "I wanted this to work so badly," she wrote on a discussion board.
One week after LabCorp's announcement, the Society of Gynecologic Oncologists in Chicago, Illinois, released a statement expressing concern about OvaSure, saying that "additional research is needed to validate the test's effectiveness". The paper in Clinical Cancer Research was also circulating at the Canary Foundation, a non-profit organization based in Palo Alto, California, that funds research on early cancer detection. Scientists there found other reasons for concern. One member, Nicole Urban, head of the Gynecologic Cancer Research Program at the FHCRC, had found that levels of prolactin, one of the proteins in the panel, are highly sensitive to stress — something very likely to affect women entering the clinic with symptoms of ovarian cancer7. After controlling for that, she says, "prolactin gave no signal at all for malignancy. It was useless." Others pointed out that the high specificity and sensitivity figures reported in the paper's conclusions, and trumpeted in Yale and OvaSure press releases, were not present in any of the tables or figures. And they bristled at the positive tone of the discussion, which stated that the test "will enhance the potential of treating ovarian cancer in its early stages and therefore, increases the successful treatment of the disease".
"There were a lot of uncertainties, and evidence of biases," says Martin McIntosh, who researches markers for early-stage ovarian cancer at the FHCRC, and is a member of the Canary group, "But the narrative only highlighted the best-performing analysis. It didn't mention caveats." Members of the Canary group wrote a letter to Clinical Cancer Research, describing some of their complaints. Meanwhile, Feng agreed to co-author a second letter, criticizing the paper even though he was a co-author.
The fuss was already reaching the FDA, which on 7 August 2008 sent a letter to LabCorp saying that the test "has not received adequate clinical validation, and may harm the public health". A second letter, sent by the FDA on 29 September 2008, alleged that LabCorp did not have the necessary marketing clearance or approval for the test from the FDA. LabCorp replied to the FDA on 20 October, disagreeing with the agency's assertions, but agreed to pull OvaSure from the market. It did so on 24 October 2008, just one day after Clinical Cancer Research published the critical letters from the Canary Foundation and Feng, as well as a third from the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia8,9,10. (Millipore continues to market the biomarker panel for use in research, not by patients.)
Mor was surprised by all three letters. In his published response11, he disputed some of the criticisms and wrote that any concerns about commercialization should be taken up with LabCorp. Stephen Anderson, vice-president of investor relations at LabCorp, says that OvaSure was not marketed as a test for detecting cancer recurrence, which was how some patients used it. He says that LabCorp "continues to believe OvaSure offers a valuable tool for ovarian-cancer detection in conjunction with other diagnostic techniques", and that the assay is still in development. The company would not provide further comment.
Doubts and lessons
Since then, Mor has worked hard to validate his panel. He and Ward have completed a study on a much larger set of samples including many from women diagnosed in the earliest stages of ovarian cancer12, and in which LabCorp again ran the assays. The test still performed well at distinguishing the patients from the healthy controls. Mor says he is puzzled by the PLCO trial results, and he hopes that further analysis of the trial data will help to explain why his biomarkers performed so poorly. He continues to express confidence in his panel, saying that the test could be most useful in high-risk populations, and when used regularly — every two to three months — to monitor rising and falling levels of the biomarkers. But the whole experience has made him reluctant to pursue biomarker work much further. "I'm focusing on understanding cancer stem cells," he says.
Others say that's just as well. The panel's poor performance in the PLCO study makes critics question its usefulness in any group, even a high-risk one. McIntosh says that the PLCO study's damning conclusions should serve as a wake-up call. "The entire field has to cope with this," he says — including him, given that the most promising biomarkers discovered by his institution also failed to improve on CA-125 in the trial. "It's hugely disappointing."
The IOM committee, which is expected to release its results sometime in 2012, may help to find a way forward. At a meeting later this month, the members plan to draw lessons from the biomarker failures, as well as from the few success stories (see 'The gene collection that could'). One of the most urgent lessons is the need to help researchers validate their biomarkers on appropriate samples before they reach the clinic. Feng says that the EDRN has been collecting its own high-quality tissue reference sets for ovarian, breast, lung, colon, liver and prostate cancers, from people who aren't yet showing symptoms and those in all stages of the disease. Investigators can apply to test their biomarkers on blinded tissue samples.
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Until this type of testing becomes commonplace, there is no way of excluding the possibility that, as Hayes suggested at the IOM meeting, "these things just don't work" — particularly when it comes to picking up cancer early on.
"People keep talking about early-detection biomarkers as if they are a fact, and we only need to find them," says McIntosh,"when in reality their existence is a hypothesis that needs to be tested."
http://www.nature.com/news/2011/110323/full/471428a.html
2011-11-09 09:51 ET - News Release
RICHMOND, British Columbia, Nov. 9, 2011 (GLOBE NEWSWIRE) -- BioCurex Inc. (OTCBB:BOCX) announced today that its wholly owned subsidiary, OncoPet™ Diagnostics, Inc., has signed a distribution agreement with Webster Veterinary Supply for the distribution of the OncoPet Sample Collection Kit for canine cancer diagnosis. Webster Veterinary, is a division of Patterson Companies, Inc.
As previously announced in a press release dated September 26, 2011, OncoPet™ changed the model for the OncoPet Sample Collection Kit with the development of a kit that safely stabilizes samples for a period of two weeks at room temperature, reducing shipping costs of the samples by up to 90 percent.
Per the non-exclusive distribution agreement, Webster Veterinary will be allowed to purchase the test kits from OncoPet and distribute the OncoPet Sample Collections Kit to veterinarians, veterinary practices, veterinary hospitals and others within the United States and territories of the U.S. including Puerto Rico, Guam as well as others.
"This marks our first agreement for the distribution of the OncoPet Sample Collection Kit in the United States," stated Dr. Paul D. Slowey, President of BioCurex. "This agreement marks a significant milestone and more importantly, a third party validation of our canine RECAF™ technology as a commercially viable product. To that end, annual sales from this distribution agreement alone can potentially get the company to breakeven. We look forward to working with Webster Veterinary and to further expand our distribution network for OncoPet in the U.S. and around the world."
There are approximately 74.8 million owned dogs in the United States. On average, dog owners spent $219 on veterinary visits (vaccine, wellness visits, etc.) annually. Cancer is the cause of nearly half the deaths of older dogs (10 years and up), according to the American Veterinary Medical Association (AVMA), and according to the National Canine Cancer Foundation, canine cancer effects one out of every three dogs.
About Webster Veterinary
Webster Veterinary, a leading distributor of consumable veterinary supplies, equipment and software, diagnostic products, vaccines and pharmaceuticals to veterinary clinics, is part of the progressive, global Patterson Companies (Nasdaq:PDCO) family of businesses.
Bill Aims to Extend $1B Small Biotech Credit
May 27, 2011
By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – A new bill in the US House of Representatives aims to revive and extend a temporary program that provided $1 billion for grants and tax credits to small biotech and pharmaceutical firms working on therapies and biomedical innovations.
The one-year Qualifying Therapeutic Discovery Project that was created as part of the Patient Protection and Affordable Care Act under the new bill would provide $1 billion per year between 2011 and 2017.
Introduced by Representatives Susan Davis (D – Ca.) and Allyson Schwartz (D – Pa.), the Qualifying Therapeutic Discovery Project Tax Credit Extension Act of 2011 (H.R. 1988) would enable small businesses with less than 250 employees to choose a grant over receiving a tax credit, so that firms that are not yet profitable can benefit from the program.
The credit or grant will cover up to 50 percent of the cost of biomedical research up to $5 million per firm, and they will be available for investments made in 2009 and 2010 and through 2015.
It is aimed at supporting efforts to develop technologies to prevent, detect, or treat chronic or acute diseases and conditions that will significantly advance the goal of curing cancer within 30 years and help to reduce the long-term growth of healthcare costs in the US.
These credits and grants will fund a range of research efforts beyond therapeutic development, including personalized medical innovations using genetic testing and pharmacogenomics applications.
"Smart, targeted tax credits and grants like this effort are exactly the types of investments we must make to ensure America leads in a global economy driven by innovation and forward-thinking ideas," Schwartz said in a statement Thursday.
Biotechnology Industry Organization President Jim Greenwood said that the first year of the program funded nearly 3,000 companies and added that this bill will "support continued American innovation and accelerate the development of life-saving cures for numerous prominent diseases, such as cancers, mental illnesses, heart disease, and Parkinson's disease.
"The bill provides much-needed support for biotechnology companies working on breakthrough therapies that could ultimately lower overall healthcare costs and cure these debilitating diseases within the next 30 years," Greenwood added.
The bill was introduced in the House this week and no further actions have yet been taken.
Among the firms that received grants and credits under the program last year were High Throughput Genomics, DNA Medicine, Health Discovery, Provista Life Sciences, Quanterix, the DNA Medicine Institute, On-Q-Ity, Empire Genomics, as well as a number of other 'omics companies.
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How can anyone trust our government data on Cancer?
Incidence data for 2005 through 2007 were affected by data sharing restrictions within the Veterans Health Administration (VHA). VHA hospitals have traditionally been a critical source of data for cancer cases diagnosed among veterans served by those institutions. The new requirements restrict the submission of cancer cases to central cancer registries, however, resulting in incomplete reporting of VA hospital cases in some registries. VA cases account for at least 3 percent and possibly as much as 8 percent of all cancer cases diagnosed among men. Therefore, incidence rates for men may be underestimated.
Gold, Please tell me which stock is going to double tomorrow and which one for Wednesday, Thursday and Friday. They are unknown today but will be very popular tomorrow.
Biocurex is just like that. When it comes out that it is approved or approvable and that it is a companion test for PSA and or the CEA or CA-125 or for the mammogram etc. That is when it will be talked about.
Apparently nobody knew about Medivation a week ago even though it was in clinical trials. Who knew it would increase ones life span by an amazing 4.8 months? Then it went from low interest to very High interest overnight.
Medivation rose $23.22 to $39.75 at 4:00 p.m. New York time, in the biggest percentage increase since April 2004. The trial of the medicine, called MDV3100, was in the final stage of clinical development generally needed for U.S. marketing approval. An interim analysis showed that patients on the medicine lived 4.8 months longer than those on a placebo, according to a statement today from Medivation, based in San Francisco, and its partner, Tokyo-based Astellas Pharma Inc.
“There was a lot of anxiety about the event, so most of the investors who typically own companies like this weren’t involved,” said Geoff Porges, an analyst at Sanford C Bernstein in New York, in a telephone interview. “So now there’s a buying spree as people realize this is a real company.”
Gold, You continue to compare Radient Pharma to Recaf. This was previously addressed in October 2010.
Even you posted some time back that Radiant's test is subpar to Recaf.
"Gold stated,"This is like a breath of fresh air. I was very depressed that a test supposedly equivalent to RECAF was selling so poorly. Now we understand why. It's actually less than worthless.
Gold, there are not many people or companies interested in a blood clotting diagnostic test such as your Radiant Pharma when it comes to cancer issues...
Maybe they would be better suited in selling tests to monitor blood clots or for potential infections for patients who recently had surgery than they would for attempting to find blood clots in individuals who may have cancer...
As previously posted, You continue to compare RPC with Recaf as a cancer diagnostic test. I would choose Recaf over RPC any day...
It is no wonder the doctors are hesitant in using RPC for cancer tests. Maybe you should be comparing RPC with the Digital Rectal Exam. They are closer in comparison.
Gold stated," Radient Pharmaceuticals has been doing a similar process of signing distributors for their Onko Sure test for over a year now for specific countries or regions. Unfortunately, the contracts do not have requirements for minimum yearly sales and thus far, RPC has gotten few sales at all from their distributors."
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=55484172&txt2find=radiant
Holy Moley Gold...there is something worse than the removal of the prostate resulting from the biopsy process... Keep in mind that Biocurex Recaf test can prevent 66% of unnecessary prostate biopsies.
See link below.
http://www.prostate-cancer.com/prostate-cancer-glossary/Surgical-Castration.html
If 4.8 Months is considered a success in the eyes of the FDA, Recaf should be considered the ultimate of success ! See link below.
http://www.bloomberg.com/news/2011-11-03/medivation-shares-more-than-double-on-prostate-cancer-drug-trial-data.html
Gold, Assuming your numbers are correct???
The administrative costs are also for R&D What do you think all of the workers have been doing that require administrative pay . You have called Biocurex in the past...Until recently the calls were going right into the lab.
Therefore your statement was and is incorrect.
Gold stated, "He has used tons of them and spent more money hyping the stock than he has on R&D."
Gold I disagree with your statement regarding Biocurex spending more money "hyping" the stock than on Research and development.
Can you please show me the numbers you are looking at so we can all make a determination?
Hungry,
For clarification, your posts seem to conflict with one another...Which is it?
I'm a scientist and business student
Or
I'm a science and business student
I just want to gather information to decide whether to invest in this stock.
Or
My involvement in this forum was the result of a school assignment to research the effect of PRs and investors' forum in the value of penny stocks.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=67645175&txt2find=scientist
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=68517566
Dr. Moro stated, "I am extremely pleased by the response our presentations have elicited from the conference. Two large companies ($0.5 and $2.5B a year) expressed interest in our tests with the largest one approaching us shortly after presenting our data.
TOP IN-VITRO DIAGNOSTICS MANUFACTURERS (2005)
1. Roche Diagnostics $6.3 billion
2. Abbott Laboratories $3.8 billion
3. Bayer Diagnostics $2.5 billion
3. Becton, Dickinson and Co. $2.5 billion
5. Beckman Coulter $1.9 billion
6. Dade Behring $1.7 billion
7. Ortho-Clinical Diagnostics $1.4 billion
8. bioMérieux $1.2 billion
9. Sysmex $716 million
10. Bio-Rad $618 million
11. Arkray $470 million
12. Diagnostic Products $399 million
13. Olympus America $384 million
14. Cytyc $362 million
15. Gen-Probe $306 million
Gold stated,"Moro has NOT reported submitting ANYTHING to the FDA."
Gold, This is why I use the colors....
BioCurex Submits Pre-Investigational Device Exemption (IDE) to the FDA for RECAF(TM)
BioCurex Submits Pre-Investigational Device Exemption (IDE) to the FDA for RECAF(TM)
RICHMOND, British Columbia, Oct. 7, 2011 (GLOBE NEWSWIRE) -- BioCurex, Inc. (OTCBB:BOCX) announced today that the Company has 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 a previous announcement, BioCurex compared the performance of RECAF and free-PSA to discriminate prostate cancer from benign prostate hyperplasia (BPH), a common benign condition that requires no surgical treatment. The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies. (BioCurex's RECAF(TM) Blood Test for Cancer Can Prevent Two Thirds of Unnecessary Prostate Biopsies Sep 8th, 2011).
The INTENDED USE in the submission reads: "The serum-RECAF(TM) CLIA test is an in-vitro device for the quantitative measurement of RECAF (receptor for Alpha-fetoprotein) in human serum. The RECAF test is intended to be used in men aged 50 years or older with total PSA values between 4-10 ng/ml and non-suspicious DRE. The RECAF value can be used as an aid in discriminating between prostate cancer and benign disease. Prostatic biopsy is required for the diagnosis of cancer".
Dr. Ricardo Moro, CEO of BioCurex, stated, "This pre-IDE submission is the first step toward seeking FDA approval of our RECAF(TM) test. This process is aimed at avoiding errors and detours on behalf of the applicants and therefore, should help to speed the regulatory process."
According to the FDA, the pre-IDE process can be
of as a "pre-submission" process. It may involve sending analytical or clinical protocols to FDA for review and comment before proceeding with studies. The process may also involve a meeting with FDA to discuss protocols and/or possible regulatory pathways. Pre-IDE submissions and meetings are strictly voluntary, and any comments or recommendations made in the review of protocols or during these meetings are not binding on the Agency or the Sponsor. A submission made under the pre-IDE process is not an official IDE application as described in 21 CFR Part 812. In fact, most in vitro diagnostic devices (IVDs) are exempt from the medical device IDE regulations as long as conditions in 21 CFR 812.2(c)(3) are met.
http://www.canaryfoundation.org/publications/pre-IDE%20integ rated%20v03%20030421.pdf
http://www.fda.gov/medicaldevices/deviceregulationandguidanc e/ivdregulatoryassistance/ucm123682.htm#4b and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMark etYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#pre_ide)
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.
International Filing Date: 21.10.2010 ...
So what? That was 1 year ago? The human test was being converted only in April of 2011 (only 6 months ago)..Do you understand how things work in the real world?
Note the date of this Gold..Date: April 14, 2011 09:30 ET
Currently, the Company is concentrating its efforts on converting the human cancer blood RECAF test to the peptide version. The BioCurex team believes that this will be very advantageous with the Company's strategy concerning current licensees, additional licensing partners, and filing FDA applications with this test as explained in previous releases.
http://webfarm.bloomberg.com/apps/news?pid=20670001&sid=acelQ5Z4M26s
Now in only 6 months time, Dr. Moro presented the human application at the ISOBM, he has submitted it to the FDA,and is discussing it with current licensees as well as potential licensees. This is all new to the public. It appears that they are liking it, but it is all new....
Gold, may be you should consider that technologies do not go from Mary had a little lamb directly to a full blown conference call to discuss an in home theatre in six months time.
Come on Gold. Please name any current marker on the market that doesn't deal with the personal tracking....
PSA, CEA, CA125, Even your DRE the list goes on and on Gold
They all have an overlap and false postives. EVEN the Biopsy can have this...
The only sure things in life are DEATH and Taxes !!!
Short of these...You will never get a 100% perfect test Gold....So why do you watch the Billions of dollars in sales from all of the current cancer tests and yet you condemn any one test that is not perfect? Including the ones currently in use? including the one you depend upon...
That path of logic blows my mind!!!
Gold, staed, "why has Moro not given any data as to how much better it is?"
Dr. Moro did release the peptide results to those who need to know them.The second presentation showed the actual results obtained on patients using the peptide based test.
And what did they say about the results you ask?
Dr. Moro stated, "I am extremely pleased by the response our presentations have elicited from the conference. Two large companies ($0.5 and $2.5B a year) expressed interest in our tests with the largest one approaching us shortly after presenting our data. In addition, we discussed several collaborative opportunities including one to expand the results for prostate cancer screening and another to monitor patients previously treated for cancer. The latter is of particular interest because there is mounting evidence that survival is improved if patients in remission are monitored with cancer markers and treated when the marker starts increasing and before the metastases become clinically evident. The problem is that current cancer markers are abnormally high only in a small minority of the most common cancers such as lung and breast. On the other hand, RECAF works very well for those malignancies and therefore the interest in using it for this purpose".
RICHMOND, British Columbia, Aug 25, 2011 (GlobeNewswire via COMTEX) -- BioCurex Inc. /quotes/zigman/279657 BOCX +3.85% -- today announced that the Review Board for the 39th Annual Meeting of the International Society for Oncology and Biomarkers (ISOBM), has accepted two presentations on recent advances using BioCurex's novel Pepto-RECAF(TM) peptide technology. These presentations, taking place in Florence, Italy, will describe the discovery process for the peptide as well as the rationale for utilizing a synthetic peptide as a superior alternative to an antibody in commercial versions of the RECAF(TM) blood test for cancer.
A synthetic peptide is made by a chemical process controlled by an automated instrument in which the required amino acid sequence is programmed. Using a small molecule, a peptide based approach results in a "cleaner" product, with fewer opportunities for non-specific binding that can lower the accuracy of the test. This significantly increases precision to assays (tests) incorporating the new peptide. BioCurex has been able to effectively demonstrate the advantage of this approach by substituting Pepto-RECAF(TM) instead of a regular antibody in the OncoPet (canine) cancer test, where it has shown a highly significant reduction of artifacts such as false positives among dogs with benign diseases.
The Pepto-RECAF(TM) technology is not only superior to antibody-based technologies in this particular case, but importantly, it also adds almost 20 additional years to BioCurex's technology patent protection, which is an important consideration for potential strategic partners and putative licensees. Based on the extended patent protection, the cost reduction and the overall improvement in performance provided by this new technology, the Company hopes to attract the interest of large diagnostic companies present at this congress.
The title of the communications are:
AFP PEPTIDES THAT BIND TO THE AFP RECEPTOR (RECAF)
and
RECAF SERUM TEST USING AN AFP DERIVED PEPTIDE INSTEAD OF ANTIBODY.
The ISOBM is an international society dedicated to cancer and biomarkers ( http://isobm.org ).
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 /quotes/zigman/216393/quotes/nls/abt ABT +0.17% and with Alere /quotes/zigman/604816/quotes/nls/alr ALR +0.23% , formerly Inverness Medical Innovations.
Gold, When was the Peptide for Recaf completed?
What is the improved cancer / normal ratio of the Peptide Recaf?
What was the ratio Abbott was intereste3d in?
How many years have you had the DRE performed?
Gold stated, "For THREE years, Moro has not been able to get anyone interested in combining PSA with RECAF?"
Gold stated, why has Moro not given any data as to how much better it is?
From your response Gold,you just admitted that YOU HAVE NO IDEA HOW MUCH BETTER THE PEPTIDE WORKS and yet you continue to say that it is subpar....That is not very scientific answer Gold..
Gold, the CIA assay did not use the peptide. The question to you was, What is the cancer / normal ratio Abbott expects?
It is obvious that you do not know what the ratio was that they were interested in nor do you know if the peptide has equalled or surpassed it and yet you assume that the peptide Recaf is subpar. That is not a good answer Gold.
You continue to call Dr. Moro a liar and yet you don't even know what you are talking about.
You know that Abbott did not use the peptide when Mr. Frost was around and yet you continue to say the peptide is not good but you can not tell the board of the status of the peptide's cancer normal ratio
YOU STATED, "Burger was going to meet with Abbott in Jan 2010 to get them "back on track" and again said he was going to meet with them in Jan 2011 to present the peptide."
You don't know if Mr. Burger did or did not meet with Abbott or Alere nor do you know what was discussed so you state "but we never heard anything about any discussions"...
So you automatically call the meeting a negative? hmmmm?
So then you stated at the end of your post," One thing for certain," which ultimately shows the board that none of your other claims are certain...
Gold, So you tell me...You continue to spew these generic terms and demands that Abbott does or does not ...
How much better does the peptide work than the Style Abbott reviewed?
What is the cancer / normal ratio Abbott expects?
Do you know if Mr. Burger did or did not meet with Abbott?
What was discussed in the meeting?
What did Abbott Say?
You don't like Ihubs choice of highlighted colors?
Gold, you are losing your grip ! The big picture is coming to fruition.
We now have an improved stable product.
Using a small molecule, a peptide based approach results in a "cleaner" product, with fewer opportunities for non-specific binding that can lower the accuracy of the test. This significantly increases precision to assays (tests) incorporating the new peptide.
Another important issue was the patent and its performance.
it also adds almost 20 additional years to BioCurex's technology patent protection, which is an important consideration for potential strategic partners and putative licensees. Based on the extended patent protection, the cost reduction and the overall improvement in performance provided by this new technology, the Company hopes to attract the interest of large diagnostic companies present at this congress.
Publications based on the advancements are being published and is nailing the current short falls of mammograms.
"Increased AFP-Receptor (RECAF(TM)) Values in the Serum of Patients With Early Stages of Breast Cancer" has been accepted for publication in a peer reviewed medical journal.
judged by the reviewers as 'compelling' and 'impressive'. It is indicative that we are on the right track and that we have something of significant medical value."
The new advanced RECAF is nailing the prostate Free PSA shortfalls.
The RECAF test outperformed the established free-PSA test by approximately 600% in its ability to prevent unnecessary prostate biopsies.
The new advanced RECAF is now in front of the FDA
BioCurex Submits Pre-Investigational Device Exemption (IDE) to the FDA for RECAF(TM)
The advanced RECAF is now more stable as a peptide as well as less expensive and easier to produce with a better shelf life.
Large companies are taking notice ! I look for them to sign as well as for ABBOTT & Alere to advance the new peptide as it is stable, easily manufactured and patentable.
Two large companies ($0.5 and $2.5B a year) expressed interest in our tests with the largest one approaching us shortly after presenting our data. In addition, we discussed several collaborative opportunities including one to expand the results for prostate cancer screening and another to monitor patients previously treated for cancer. The latter is of particular interest because there is mounting evidence that survival is improved if patients in remission are monitored with cancer markers and treated when the marker starts increasing and before the metastases become clinically evident. The problem is that current cancer markers are abnormally high only in a small minority of the most common cancers such as lung and breast. On the other hand, RECAF works very well for those malignancies and therefore the interest in using it for this purpose".
Hmmm Just in time to sign a third License then !!
Looking for some very great news very shortly...
"On the other hand, if there is any substance to his recent message and an agreement is penned with another, credible party, the stock could still soar"
Dr. Moro stated, "I am extremely pleased by the response our presentations have elicited from the conference. Two large companies ($0.5 and $2.5B a year) expressed interest in our tests with the largest one approaching us shortly after presenting our data. In addition, we discussed several collaborative opportunities including one to expand the results for prostate cancer screening and another to monitor patients previously treated for cancer. The latter is of particular interest because there is mounting evidence that survival is improved if patients in remission are monitored with cancer markers and treated when the marker starts increasing and before the metastases become clinically evident. The problem is that current cancer markers are abnormally high only in a small minority of the most common cancers such as lung and breast. On the other hand, RECAF works very well for those malignancies and therefore the interest in using it for this purpose".
The entire story is in the link below
http://www.globenewswire.com/newsroom/news.html?d=236216
Tentacle, It is interesting that we tend to say someone has liver cancer or prostate cancer or etc. etc.
I don't think it is that simple though..
Scientists at the University of Michigan have identified at least 24 different kinds of prostate cancer of varying virulence whose DNA signatures can be read like a bar code.
I do believe each type of cancer has multiple subsets....
Hungryleon, you should be impressed by me and what I stand for! You should also be even more impressed by Dr. Moro and his team. They may save your life or someone dear to you soon.
My Grandmother died of lung cancer.
My Mother has ovarian cancer
My mother in law had breast cancer
My Father in law had prostate cancer as well as bladder cancer
My brother in law had prostate cancer
My sister in law had skin cancer
I have lost countless friends from colon, breast, lung, bladder, breast, ovarian, stomach, throat, brain cancers
I would surely welcome and protect anyone as a friend who could provide a better early detection for cancer.
The shares in this company may very well pay off handsomely and soon . However, all of the money in the world will not bring back my friends. My hope is that Dr. Moro will assist me in helping my living family, wife, children and friends with a good early detection for cancers so that they become survivors of cancer in lieu of statistics of cancer. He may also bring to the forefront a cure for cancer that does not require a knife.
I would think that you as a proclaimed "scientist" would also appreciate someone of Dr. moro's abilities....
I also realize that we are posting on a board with aliases. You may be a scientist or may be not, and as far as you know, You might watch me often on television?
Good day
Steve Jobs had a slow growing cancer. The outcome? lets see what the oncologist added below.
Steve Jobs regretted cancer surgery delay, biographer says
October 20, 2011, 7:25 p.m.
Steve Jobs, who died of pancreatic neuroendocrine cancer earlier this month, did not allow doctors to perform what could have been potentially life-saving surgery for nine months, according to the former Apple chief executive's biographer Walter Isaacson.
Isaacson told "60 Minutes" that Jobs was "regretful" about the decision to pursue alternative therapies instead of immediately going under the knife, according to a preview clip.
"He tries to treat it with diet, he goes to spritualists, he goes to various ways of doing it macribiotically -- and he doesn't get an operation," Isaacson recalled.
Looking for what are termed alternative, complimentary therapies is not unusual, said Dr. Jack Jacoub, a medical oncologist at Orange Coast Memorial Medical Center in Fountain Valley.
"It's quite common, I have to tell you -- and very distressing," said Jacoub, who added that many of his patients try out a wide range of such therapies. "To actually shun conventional medicine and do these untested, unfounded forms of treatment is really doing a disservice to the patient."
As for why the man behind the iPhone avoided surgery, "He said, 'I didn't want my body to be opened.... I didn't want to be violated in that way,' " Isaacson said in the interview, set to air Sunday at 7 p.m Eastern and Pacific.
Such reluctance is understandable, Jacoub said.
"Going under the knife is very scary," he said. "It's a natural human response."
That said, the oncologist added, "Most people, when you say they have cancer, they say, 'Can we cut it out?' And that's the right question."
As for whether the nine-month delay would have made the difference between recovery and death on this rare, typically slow-moving form of pancreatic cancer, Jacoub said it was somewhat unlikely -- unless the tumor in the pancreas had already been near the verge of becoming inoperable when the option of surgery first came up.
"I personally would find it a bit difficult to say a nine-month delay made the difference, but yes, it's possible," Jacoub said.
Regardless, putting off this kind of surgery is generally not a good idea, he added, because "if you delay the time to definitive therapy, your outcomes are worse. Six months, 12 months, 18 months -- that gives time for the cancer cells to spread outside the primary site."
http://www.latimes.com/health/boostershots/la-heb-steve-jobs-apple-pancreatic-cancer-surgery-20111020,0,1704501.story?track=rss
Well Gold...I continue to look for what doctors have to say about treating cancer or waiting. I keep getting the same response...
Herman Cain’s Cancer Miracle — How He Did It
Friday, October 21, 2011 11:48 AM
By Charlotte Libov
Herman Cain credits a miracle from God for saving him from advanced colon cancer.
But a top colon cancer expert tells Newsmax Health that the Republican presidential candidate also benefited by acting quickly once his cancer was diagnosed in 2006 and by being smart about his choice of treatment centers.
David Maron, M.D., a colorectal surgeon at the Cleveland Clinic Florida, has treated many patients with stage 4 colon cancer such as Cain’s. "Herman Cain obviously didn't waste any time getting treated, and that certainly helped him survive," Dr. Maron said.
Cain, 66, a former pizza executive, describes himself as a Baptist preacher, and attributes his recovery to God. And, indeed, Cain recently passed the five-year survival point for colon cancer patients, and says he is now cancer-free.
Editor’s Note: Special: Herman Cain Unmasked. Read This Now.
According to his own account, Cain went to his doctor because he was experiencing lower abdominal discomfort. The tests came back with perhaps the worst possible news: that he not only had cancer but that it had spread to his liver. This type of cancer is considered stage 4, or advanced, and it seemed at the time that the businessman did not have much time left.
Cain says he was given only a 30 percent chance of survival.
But almost immediately after his diagnosis, he traveled for treatment to the University of Texas MD Anderson Cancer Center in Houston, one of the top cancer treatment centers in the country. “Fast treatment by the right doctors can be vital” to survival, said Dr. Maron.
Recent reports state that Apple computer boss Steve Jobs delayed his surgery for pancreatic cancer for nine months after his diagnosis, leaving some to wonder whether faster action could have saved his life.
At MD Anderson, Cain underwent a single operation in which the cancerous parts of his colon and liver were removed. He also had two rounds of chemotherapy.
According to Dr. Maron, stage 4 colon cancer patients whose cancer is inoperable have an exceedingly poor prognosis. Fortunately, for Cain, his cancer was located in areas where it could be removed. “In patients (like Cain) where the cancer has metastasized (spread) to a local, isolated area, the survival rate is much better,” Dr. Maron noted.
Cain also benefited from improved surgical techniques, said Dr. Maron. He underwent an operation to remove the cancer from both the colon and the liver at the same time instead of having separate operations to remove the cancer from each organ.
These days, colon cancer patients are also helped from better treatments, including more effective chemotherapy drugs, to shrink tumors prior to surgery and to keep them from coming back.
Doctors also have other weapons that have been developed in recent years, including cryotherapy, which freezes cancer cells, or radiofrequency ablation, which uses heat to kill malignant cells that have spread to the liver.
Such progress promises to transform advanced colon cancer “from a terminal disease into a chronic, manageable one,” Dr. Maron said.
Still, the best way to treat colon cancer is to undergo screening so the disease can be caught before symptoms appear, giving patients a better than 90 percent chance of survival. Doctors recommend that everybody get a colonoscopy or other colon screening at age 50, or earlier if there is a family history of colon cancer. There are expected to be more than 100,000 new cases of colon cancer diagnosed in the United States this year, with about 49,000 Americans dying from the disease. Colon cancer is the third leading cause of cancer death in the United States.
The fact that Cain has been cancer-free since 2006 bodes well for his future, said Dr. Maron: “Typically, we follow these patients for five years and once they pass that mark, their risk of cancer recurring is exceedingly low.”
Myth: prostate cancer is slow growing and does not need treatment.
FACT. Prostate cancer is the second leading cause of male cancer deaths after lung cancer and therefore needs to be reckoned with. Prostate cancer has a very varied biological behavior from slow growing to very aggressive so each man needs to be individualized. Each man can only be counselled effectively based upon a well performed needle biopsy of his prostate to determine the tumor volumes, the Gleason scores and the regions of the prostate involved.
A myth is an imagined but UNREAL event
http://www.hifurx.com/prostate-cancer/prostate-cancer-myths/