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Biomarkers in Medicine
June 2010
The dire need to develop a clinically validated screening method for the detection of early-stage ovarian cancer
Ny Sonia Dutta?, Feng-qiang Wang? and David A Fishman
For almost half a century, the WHO has urged the medical community to create screening methods with the primary purpose of detecting disease at an early, treatable stage [1]. This is of particular importance in epithelial ovarian cancer (EOC) given that there are no clinically validated biomarkers or screening protocols available..........
Full text:
http://www.futuremedicine.com/doi/full/10.2217/bmm.10.54
Some excerpts:
"Given ovarian cancer’s relatively low general population incidence rate (1.8%) [2], a valid screening test must have both a high sensitivity and a high specificity to decrease the number of false-positive test results and the subsequent invasive surgical procedures undoubtedly associated with this result. The ideal screening test for the postmenopausal population (with a prevalence of one in 2500) would require a specificity of 99.6% to yield an approximate positive predictive value of 10%, where a surgeon performs ten operations for each case of ovarian cancer detected. The positive predictive value of most screening tests is determined by specificity and disease incidence – given ovarian cancer’s low frequency, achieving an acceptable positive predictive value requires an extremely high specificity, especially in average-risk populations."
"Multiple initiatives have been undertaken to discover strategies that detect and diagnose early-stage EOC, including the search for novel serum biomarkers and the development of new technologies, such as contrast-enhanced ultrasonography, with a number of them demonstrating hopeful results. The ideal screening test for ovarian cancer would be a simple measurement of biomolecules in bodily fluids, such as blood, serum or urine, whose absolute concentrations could differentiate cancer from noncancer and be organ specific. In the last decade, insights into the EOC microenvironment, as well as technological advances, such as microarrays and proteomics, have triggered the discovery of hundreds of potential clinically valuable biomarkers:
? Lysophosphatidic acid (LPA)... (description follows)
? Human epididymal protein (HE)...(description follows)
? Osteopontin (OPN)... (description follows)
? Kallikreins (KLKs)... (description follows)
? Claudins )... (description follows)
In addition to the biomolecules mentioned previously, patient-derived tumor-reactive antibodies are also considered to be new diagnostic markers.....
Of particular note, traditional genetic pedigree analysis of ovarian cancer patients may provide information to help identify high-risk populations;....
Despite these advances, at present, no clinically validated screening protocol for the detection of early-stage EOC exists. The discovery of novel biomarkers relies on obtaining a better understanding of the initiation and progression of EOC. Clinical validation and implementation of biomarkers will also benefit from advancements in new molecular and imaging technologies as patient care is optimized. Fortunately, hundreds of biomarkers have been identified; however, their clinical utility remains to be determined. In addition, the enhanced imaging capabilities of the ovary by ultrasound are providing practitioners with the ability to more accurately and precisely identify changes specific to the newly transformed ovary. The combination of these two modalities, biomarker panels and biologically based imaging may be the future. Therefore, we must forge ahead to develop a validated early-detection protocol that will not only decrease the number of advanced-stage diagnoses and deaths attributed to ovarian cancer but, most importantly, positively impact the future of women’s healthcare.
Blood relations: New study explores early detection of ovarian cancer
June 16, 2010 by Richard Harth
Despite many research advances, ovarian cancer remains lethal in a majority of cases, due to late diagnosis of the disease. In a new study, Dr. Joshua LaBaer of the Biodesign Institute at Arizona State University, along with Arturo Ramirez and Paul Lampe, researchers at the Fred Hutchinson Cancer Research Center in Seattle, used a novel method for identifying biomarkers—proteins in blood that can identify ovarian cancer before symptoms appear.
The work, which appeared recently in the journal Molecular and Cellular Proteomics, holds the potential for significant improvements in patient survival rate. The research is part of the Early Detection Research Network program of the National Cancer Institute.
As LaBaer notes, ovarian cancer is an attractive target for biomarker study. "This is a disease for which an early diagnostic test would make an enormous difference in the health of women." Highly treatable in its early stage, ovarian cancer is typically not identified until it has progressed to stage 3 or beyond. Often, it is detected accidentally, in the course of some other test or procedure, for example, during an oophorectomy. "By the time it's caught," LaBaer says, "it has usually speckled the abdomen with advanced tumors."
At present, only one reliable biomarker for ovarian cancer exists. Known as CA 125, this protein is produced on the surface of cells and released into the bloodstream. Elevated levels of CA 125 are indicative of ovarian cancer, but testing for CA 125 alone is not adequate. Such tests can produce both false positive and false negative results. Further, the level of CA 125 tends to go up in proportion to tumor growth, sometimes providing strong evidence only after the disease has reached its later, terminal stages.
LaBaer stresses that reliable early detection will require the discovery and combined application of multiple biomarkers. One innovative way to hunt for them involves the use of antibodies. These proteins—produced by the B cells of the body's immune system—are able to selectively bind with disease-associated antigens. Various techniques permit researchers to probe blood serum, pulling out the antigens that bind to the antibodies and observing them with the aid of fluorescence or other methods.
Traditional means of producing antibodies for research are labor-intensive and cumbersome, requiring injection of antigens into animals, which then act as production sites for the antibodies of interest. A new method however allows antibodies to be engineered synthetically. In this scenario, the portion of the antibody responsible for binding with an antigen, known as the variable region, is built from amino acids. These single chain variable fragments or scFvs can be inserted into bacteria, which act as vectors for the antibody fragments, much as a mouse or other animal would carry a traditional antibody.
scFvs encoded in bacteria have been assembled into vast libraries, capable of probing the full complexity of proteins found in blood. When an scFv detects something unusual in the blood that may suggest an abnormality, it binds to it, just as in a normal immune response. Ramirez used a library of scFvs to find which antibody fragments selectively attached to proteins in blood carrying ovarian cancer, eliminating the antibodies that bound with proteins in normal blood. The method yielded 19 distinct scFvs that appeared to display specific affinity for proteins exclusively found in ovarian cancerous blood serum.
Identification of the protein antigens bound to these scFvs however, proved far trickier. After several years of frustrating attempts to recognize these protein culprits, Ramirez teamed up with LaBaer, applying a new method that would allow them to screen the cancer-associated scFvs against thousands of proteins of known sequence.
The technique—known as NAPPA (for nucleic acid programmable protein array), provides a convenient means to display thousands of different proteins. Further, proteins used in NAPPA are synthesized freshly for each experiment and do not require the lengthy processes of purification necessary with conventional protein arrays.
When the team screened the 19 selected ScFvs, they found that about two thirds stuck to a target in the NAPPA array, allowing for positive identification. Intriguingly, these distinct ScFvs bound with the same protein, evidentially attaching to different regions. As LaBaer notes, this fact offers tantalizing hints that the technique may indeed have sniffed out a consistent biomarker for ovarian cancer, rather than anomalous proteins lacking true predictive power.
The study also examined proximal tumor fluid for ovarian cancer, detecting in high concentrations the key protein antigens identified with the microarray. According to LaBaer, this finding provides further support for the idea that these proteins are indeed associated with ovarian cancer, and do not represent mere anomalies.
Ramirez and Lampe plan follow-up work to further validate the proteins discovered and assess their clinical value as early detectors of ovarian cancer. They also have protein candidates for other cancers and hope to screen these as potential biomarkers, using LaBaer's NAPPA technology.
Provided by Arizona State University
------------------
We don't know anything yet about the "100 biomarkers" that OvaDx uses. Do doctors and the scientific community need to know what the 100 biomarkers are in order to assess the test?
From the presenting companies at the SCIA investor conference, you left out Provectus Pharmaceuticals (PVCT) one of the 6 companies that presented along with ARYC.
Dr. Craig Dees's the CEO made a compelling technical presentation of the two drugs PVCT is developing:
PV-10, which utilizes a dye called Rose Bengal to selectively target and kill cancer cells. Currently, the drug is preparing to begin Phase III trials for metastatic Melanoma, after showing promise in its Phase II trial results. The drug is also effective against liver and breast cancer and possibly others. The drug is being made available to severe patients through the FDA’s Compassionate Use Program. Since the drug has been used as a staining dye to find scratches in the eye for years, regulators view it as being relatively low-risk. They also presented at ASCO. They have worked on this drug for 8 years and spent only $78 million, compared to Dendreon that spent $1.5 billion and took 12 years to develop its drug.
PH-10 to treat severe psoriasis (clinical trials currently under way) and atopic dermatitis (clinical trials currently under way)
Provectus SCIA presentation:
http://www.sciaconference.com/PublicCo/June2010/PVCT/Index.html
Based on this info I took a small position in PVCT to test the waters.
Not too many messages in Ihub message board for PVCT. But there is a lot of buzz at the "Silicon Investor" Message board which Ihub took over recently and has the same "look and feel" as Ihub. ARYC is not in Silicon Investor yet, don't know why.
http://siliconinvestor.advfn.com/subject.aspx?subjectid=56560
Thanks Delsurfer.
Bart, the relevant tweets came from Arrayit, the parent company.
The garbage ones come from the subsidiary - ArrayitDX, John Howell CEO
Delsurfer, from where on twitter did you get the advance info.
At least the tweets you got were real news not like John Howell's ArrayitDX's constant tweets. These are some from today and yesterday. Is this what he hired ELITE for (LOL)?
ArrayitDX Market futures look forward to a DESCENDING open
ArrayitDX The Days (and Nights) Are Getting longer.interesting SA piece
ArrayitDX RT @hnshah: Nine reasons to drink green tea daily
ArrayitDX RT @chicagosinfo: Starbucks to offer free Wi-Fi access
And on and on. How much free time does he have during the work day to be putting out this garbage?
Bart here is a link from Ihub. Scroll down to the news section, or click on the NEWS tab:
http://ih.advfn.com/p.php?pid=squote&symbol=ARYC
I wonder what's going on with the stock price. It opened at 0.64 and a few minutes later a 100 share trade pushed it down to 0.55
0.55 100 OBB 09:37:51
0.60 2000 OBB 09:37:48
0.615 350 OBB 09:37:32
0.6111 350 OBB 09:37:32
0.6111 2700 OBB 09:37:26
0.6111 350 OBB 09:30:12
0.6111 1100 OBB 09:30:07
0.64 800 OBB 09:30:02
Yes, in the new OvaPlex Australian trial they are testing the addition of 2 more biomarkers to the original 5. They are trying to increase the "accuracy" to a min of 97%. Not sure if that refers to specificity or what. But to be a screening test you need close to 100% specificity (close to 0% false positives), not sure about the false negatives tolerance level (sensitivity)
Arrayit's OvaDx still seems much superior with its "100 biomarkers". I was wondering if even with FDA approval OvaDx will need peer review to confirm its results.
Also ASCO wants to weigh in about what biomarkers are used in tests (post # 866). They are supposed to issue guidelines in the future.
Trials begin on new ovarian cancer test
Posted Tue Jun 15, 2010 12:04pm AEST
Scientists in Melbourne have started trials on what they hope will be a more effective test for ovarian cancer.
The Government of Victoria has cleared a new trial for the early detection of ovarian cancer called OvPlex. The new test is developed by the biotechnology company HealthLinx in Melbourne.
The tests were launched by the Minister for Innovation, Gavin Jennings today. He stressed that these tests could change the life of millions of women around the world apart from benefitting Australian women suffering from ovarian cancer.
As part of the new experiment, Melbourne's Mercy Hospital for Women along with Mater Adult Hospital in Queensland will offer these tests to women. These institutes will be joined by several medical facilities in the UK for the trail of these tests. The test works by identifying 7 biomarkers in the blood sample of women.
The Government of Victoria is spending $750,000 to help in the development of OvPlex tests. The test is also available to women in Australia through their GPs and it is being distributed by Healthscope Pathology. The test examines five biomarkers found in the women’s blood.
In this test, apart from the existing techniques, two new biomarkers will be tested by the researchers. Experts feel that these tests offer a ray of hope to millions of cancer patients across the world.
It is expected that the new tests will improve the performance of the current tests from 94% to 97%, or even higher.
More than 1,000 women will be included in the worldwide trial.
Ovarian cancer expert Professor Greg Rice says if successful, the test's accuracy would increase from 94 to 97 per cent.
"The idea is to improve the performance of the test, to be looking at its accuracy, to identify women with ovarian cancer hopefully earlier during the course of their disease," he said.
Health authorities would need the test to be almost 100 per cent accurate before it could be used across the population.
Approximately 800 Australian women die from ovarian cancer each year.
While John Howell is aimlessly twiting this morning about the stock market:
ArrayitDX This morning’s futures foretell a HIGHER market at the open
ARYC stock is down to 0.62 (bid=0.52, ask =0.62)
You're right. The parent company's (Arrayit) twits are much less frequent and meaningful to the company,
The profile picture for ArrayitDX on twitter is a man with a mustache. Not your typical profile picture for a corporation. I assume that's John in the picture.
Here is the latest message there 15 min ago from ArrayitDX. They must have some kid (I hope) with not much to do assigned to do the twits:
ArrayitDX: First Cloned Horse Using Oocytes from a Live Mare
QuestDX only twitters when they have something meaningful to say about their company such as their last post on June 2nd:
Ovarian cancer test featured on KABC-TV Los Angeles
April 1st:
We've been honored with the CEO Gold Standard™ accreditation for our fight against cancer
Similar for othe diagnostic companies such as Roche Diagnostics.
I looked in twitter to see what messages ArrayitDX has posted in the last few days. (Talk about better PR department needed!!):
Today:
ArrayitDX Americans get most radiation from medical scans
ArrayitD Anticipate it DECISIVE at the open this morning
Friday:
ArrayitDX Mandela's Great-Granddaughter Killed in Crash
ArrayitDX FDA Panel Votes to Approve Gilenia,First Oral MS Drug
ArrayitDX Some great people to #followfriday! @DonnaPetko @SANTATIZING @ToddWeissCFA
ArrayitDX SOARING for this morning’s US stock market
Everyday ArrayitDX sends out twitter prognosticating which way the stock market is heading and general news ?!?
How about instead telling us what is going on with Arrayit company and its products?
Regarding your comment: "What is required is an announcement on positive Ovarian results prior to an FDA submission"
I understand Arrayit is committed to communicating proven results once the lab work is completed. I would not expect them to jump the gun and announce the results until the clinical trials are completed. This I believe will happen in the 3rd QTR, followed by the FDA submission.
Silver, do you have specific examples of the attitude you refer to that is making you extremely concerned? From the presentation it appeared that they have an ambitious game plan they are executing.
Provectus Pharmaceuticals (PVCT) Offers Melanoma Patients Hope as PV-10 Prepares for Phase III Trials
theotcinvestor.com
By Justin Kuepper · Monday, June 14th, 2010
With Melanoma Month over, Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT) and other companies remain keenly focused on gaining regulatory approvals for new treatments that could help patients more effectively and less painfully fight the disease. And with Dendreon Corporation’s (DNDN) recent success, cancer drugs are finally starting to become available.
Melanoma is a type of cancerous tumor that is found predominantly in skin that affects approximately 60,000 new patients per year. While it is not a common form of skin cancer, it accounts for approximately 75% of the deaths associated with skin cancer. According to a WHO report, approximately 48,000 patients die from the disease worldwide each year.
Despite biotechnology companies having invested significant time and money into finding a cure, the greatest chance of survival remains early surgical resection of thin tumors. Subsequent to the removal, adjuvant treatment, chemotherapy, immunotherapy and radiation therapy are also used, but are often extremely costly and painful with lasting adverse side-effects.
Fortunately, there are many drugs in various stages of clinical trials that promise to help combat melanoma. One of these drugs is Provectus Pharmaceuticals’ (OTC-BB: PVCT) PV-10, which utilizes a dye called Rose Bengal to selectively target and kill cancer cells. Currently, the drug is preparing to begin Phase III trials, after showing promise in its Phase II trial results.
During its Phase II trials, scientists found that PV-10 showed an Objective Response in 61% of subjects, with a Complete Response in 33% of subjects, and a logoregional disease control in 79% of subjects. Meanwhile, the compound also achieved an Objective Response in 43% of subjects with an evaluable bystander lesion.
The end result was a mean Progression Free Survival time of 8.5 months for all subjects, while the Objective Response subjects had significant longer rates estimated to be at least 11.1 months. Meanwhile, Adverse Experiences were generally mild to moderate, with no deaths or life-threatening experiences attributable to PV-10.
The drug is also being made available to severe patients through the FDA’s Compassionate Use Program. Since the drug has been used as a staining dye to find scratches in the eye for years, regulators view it as being relatively low-risk.
In the end, Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT) and other cancer treatment companies are getting close to some real solutions as Melanoma Month draws to an end.
http://theotcinvestor.com/provectus-pharmaceuticals-pvct-offers-melanoma-patients-hope-as-pv-10-prepares-for-phase-iii-trials-829/
Univ. of South Florida's RASIM GULDIKEN, MECHANICAL ENGINEERING, RECEIVES GRANT FOR SELF-ADMINISTERED TEST FOR EARLY DETECTION OF OVARIAN CANCER
The project aims to develop a prototype of a disposable, tiny (smaller than human hair or sand particle) ultrasonic MEMS sensor, enabling early ovarian cancer detection by measuring urinary protein; Bcl-2. The lack of clear symptoms and the absence of a reliable screening test for ovarian cancer results in more than 70 percent of women being diagnosed after the disease has spread beyond the ovary, so that the prognosis is poor. Patients with ovarian cancer have a short median survival time after diagnosis and their five-year survival rate is less than 40 percent.
Advantages of our nanosensor are:
1) Low cost (<$1) and battery operated
2) Simple operation (reminiscent of a pregnancy test) not necessitating trained personnel
3) Cost-feasible, easy urinary test; allowing testing to be done at home, in a physicians’ office or at a patient’s bedside.
The research results may have a worldwide impact on disparate groups, including populations with low income and medically underserved locations, and women at high risk for developing ovarian cancer. This is especially important for detection of early-stage ovarian cancer which is associated with high survival (>95%) and reduced lifelong medical costs, but currently accounts for less than 10% of diagnosed ovarian cancer cases. In addition to the nanosensor’s ability to accurately detect initial ovarian cancer cases, ovarian cancer monitoring during the course of disease may indicate recurrent disease and therapeutic efficacy.
TAMPA, Fla. (June 10, 2010) An interdisciplinary research team led by Rasim Guldiken, assistant professor of mechanical engineering, has been awarded a grant from Bankhead-Coley Cancer Research Program of Florida Department of Health for their project titled “A Novel, Low Cost, Ultra-Sensitive Nanosensor for Early Detection of Ovarian Cancer.”
The total amount of the grant is $400,000 over a three-year period.
Guldiken is principal investigator and is collaborating with USF Health (Profs. Kruk and Nicosia), who will receive $28,000 of the grant, and Harvard Medical School (Dr. Demirci), who will receive $16,000 of the grant.
Professor Guldiken received a doctorate in mechanical engineering from Georgia Institute of Technology and joined the College of Engineering faculty in 2008.
ASCO to Boost Biomarker Guidelines; First Up, Germ Cell Tumors
http://www.medscape.com/viewarticle/723349
June 11, 2010 (Chicago, Illinois) — The American Society of Clinical Oncology (ASCO) has issued a guideline on the use of serum tumor markers in the diagnosis, treatment, and management of germ cell tumors in men, which include, most commonly, testicular cancer.
The germ cell tumors clinical practice guideline was announced at a press conference here at the organization's 2010 Annual Meeting.
This is the newest guideline on the use of biomarkers for specific cancers from ASCO — with more to come as part of an "expanded series" of guidelines on biomarkers.
The initial 2 guidelines on biomarkers were on breast (2007) and gastrointestinal cancers (2006).
Why has ASCO chosen germ cell tumors, which are rare — with fewer than 9000 cases annually in the United States — for their third tumor marker guideline?
According to the panel of authors of the guideline, which was published online June 7 in the Journal of Clinical Oncology, it is "because of the large volume of publications and the long history of using serum concentrations of human chorionic gonadotropin (hCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) to guide management decisions for patients with GCT."
In short, there is clinical value in using biomarkers to help manage patients with germ cell tumors, the authors explain.
Dr. Timothy Gilligan
At the press conference, the new guideline's lead author, Timothy D. Gilligan, MD, from the Cleveland Clinic in Ohio, said that these 3 biomarkers for germ cell tumors "play a critical role in the management of these tumors."
He also hinted that some tumor markers might not be as clinically useful as the germ cell tumor markers.
Medical tests that measure tumor biomarkers are not as rigorously examined by the US Food and Drug Administration (FDA) as drugs are, he explained.
The FDA doesn't require that marker products improve outcome.
"The FDA doesn't require that marker products improve outcome. The products are only required to measure what they claim to measure," he told reporters at the press conference.
He called for "better evidence about whether tumor markers for other cancers help provide better care for patients." Specifically, he called for proof that the tumor-marker products "improve medical outcomes or quality of life."
The stakes can be high when patients undergo biomarker tests, Dr. Gilligan noted.
"Medical tests are dangerous," he said. "They can lead to a waterfall of further tests and unnecessary treatment."
Dr. Gilligan cited the use of prostate-specific antigen (PSA) as a screening test for prostate cancer as an example of a problematic biomarker that has produced overdiagnosis and overtreatment of disease. The introduction of the PSA screening test in the mid-1980s led to an estimated 1 million cases of overdiagnosis of prostate cancer by 2009, as reported by Medscape Oncology.
Dr. Gilligan called for improved tests to detect cancer. "We need better tests to detect treatable cancers earlier so that treatment will be more effective."
The future of tumor biomarkers promises to be busy, suggested Dr. Gilligan. "This is a big area of research. There are a lot of new products coming out along these lines," he said.
What's New in Germ Cell Tumor Markers
The expert panel convened by ASCO, which included Dr. Gilligan, conducted a systematic review of medical research literature, in partnership with Cancer Care Ontario, to develop the new recommendations on germ cell tumors and related serum tumor markers.
Germ cell tumors might be rare but they are also among the most curable cancers, with more than 90% of men cured, according to Dr. Gilligan. Germ cell tumors most commonly start in sperm-producing cells in the testicles. Testicular cancers are typically detected when the patient notices a swelling or irregularity in the shower or when dressing, Dr. Gilligan explained.
Testicular cancer is curable in most cases.
"Testicular cancer is curable in most cases, but proper management is key because the stakes are high, both for survival and quality of life," said Dr. Gilligan in a press statement.
AFP, hCG, and LDH should not be used to screen for germ cell tumors, to help decide whether orchiectomy is needed, or to make treatment decisions for patients with cancer of unknown origin, notes the guideline.
This news about the latter practice — using germ cell tumor markers to choose a chemotherapy regimen for patients with a cancer of unknown primary — is worth highlighting, noted Dr. Gilligan "This has been the practice, but the literature does not support use of tumor markers for this," he said.
The other most notable new recommendation, said Dr. Gilligan, is about serum tumor markers: they should not be used as part of "surveillance for stage I seminomas."
The diagnosis of germ cell tumors in men is divided into 2 different types — seminoma and nonseminoma, said Dr. Gilligan.
Generally, seminomas are relatively slow-growing; nonseminomas tend to grow and spread more quickly and are treated differently.
Seminoma cells do not produce AFP. As a result, concentrations above the normal range of AFP can occur in patients with nonseminomas but not in those with pure seminoma. In contrast, hCG and LDH concentrations above the normal range can occur with any germ cell tumor histology, write the authors of the new guideline.
A rise in these markers generally indicates disease relapse in patients who have been treated, said Dr. Gilligan.
However, as noted above, Dr. Gilligan and his colleagues recommend against using these markers as part of surveillance in stage I seminomas.
Dr. Gilligan has disclosed no relevant financial relationships.
J Clin Oncol. Published online June 7, 2010. Abstract
Watch Dr. Craig Dees's presentation at the Southern California Investors Assn. conference on June 5th. 2010. Very interesting material.
http://www.sciaconference.com/PublicCo/June2010/PVCT/Index.html
Ok got it. It's all in how they present the technology to the investors.
By the way did you catch in the presentation that Paul Haje is the VP of Marketing and Sales and that he used to work in Hollywood. Don't know what to make of that. Here is his bio.
"Mr. Paul Haje serves as Vice President of Marketing & Sales of Arrayit Corp. Paul joined Arrayit in 1999 as Director of Advertising and Public Relations, and was promoted to Vice President of Sales and Marketing in 2008. Paul graduated from the California Institute of the Arts in Valencia, California, with a Bachelors of Fine Arts, with honors. Before working at Arrayit, he worked at The Walt Disney Company, WDEMCO division, as an Associate Producer of educational films, then at Universal City Studios in Television and Theatrical Distribution. He managed his own Public Relations business for actors and businesses in Hollywood, California from 1984 to 1999"
Silver, Mark Schena may have used the wrong 100,000 example in the presentation, but he did say "up to 100,000" per chip.
The Arrayit website page that you pointed me to (msg 856) also says the following:
Arrayit (VIP) technology can be scaled down to allow testing of tens or hundreds of samples per chip, rendering it ideal for hospitals and public health facilities that process a relatively small number of samples, but require testing on a daily basis.
Thanks for the VIP technolgy info link. It is an excellent primer to the technology and very promising. Now I see what they were talking about.
Silver, you make good observations on the Plavix story. Hopefully price will be the differentiator and doctors will order the cheaper $99 Arrayit Plavix test.
On the issue of being able to test 100,000 patients at once, it went over my head. Even 10 at once. Excuse my ignorance. How is that done?
BTW, does Rene acknowledge/answer your emails to her?
That's funny. We were watching the video at the same time.
You do have a good assessment when you say that they "need capital and they need to show they can actually do this stuff and as important, that they can actually manage a public company."
Why are investors still so reluctant in investing in this company so that Arrayit gets the capital?
For OvaDx they only need $5M. investment for FDA approval. And the potential revenue is $5B.
They do say they are cash flow positive. So that's good.
Once they start getting revenues from the first blockbuster test (OvaDx) they could really develop the rest of the tests.
Just watched the video of Arrayit's Mark Schena presentation. It was informative, and the company's potential is amazing. You can watch it at:
http://www.sciaconference.com/PublicCo/June2010/Arrayit/Index.html
There were 5 additional companies presenting also.
These are the blockbuster Arrayit tests in the pipeline:
OvaDx-FDA submission Q3 '10-Expect approval Q4'10 Est.Revenue $5.B
VIP for Plavix - FDA submission Q1 2011 - Estimated Revenue $900M
Parkinson's disease - FDA submission Q2 2011 - Est. Revenue $500M
Prostate cancer - FDA submission Q4 2011 - Est. Revenue $1.5B
Last slide is exciting:
- Arrayit can become one of America's most valuable companies:
- There are 6000 known human diseases.
- Arrayit can develop a molecular test for each disease.
- 10% market share = 600 tests
- $100M annual revenue per test = $60B in sales
- $60B in sales @ 5 times sales = $300B market cap
- Arrayit can be the next APPLE
End of slide
-------------------
It is amazing that with this potential, and @ 0.70 per share, as of 12:00 noon ZERO shares have trade in the market TODAY.
NOVUSCI LTD LAUNCHES IN UK
by Dr Astrid Englezou on Tue 08 Jun 2010 08:33 AM BST
If you are looking for equipment and consumables for DNA or protein work there is a new company in the UK. Novusci Ltd has been established to provide an exclusive source for scientific consumables and equipment offering the highest quality at competitive prices; they will be representing a range of companies including:
Arrayit Corporation: The definitive source of all micro-arraying consumables and systems.
KOMA Bioscience: Innovative Molecular biology and protein consumables
AlphaHelix: The designers of the AmpXpress the PCR machine that uses IR technology to reduce run times by 60% and increase sensitivity.
The most recent addition to their portfolio is:
RBC Bioscience: Manufacturers of the Magcore HF16 the ultimate in reliable fast Nucleic acid purification, providing the ability to purify DNA from 16 samples reducing sample handling times to 30 mins .
Ralph Coney MD of Novusci said he was excited by the initial feed-back he has received from scientists in response to introducing these manufacturers to the UK marketplace. He is looking forward to installing the first Magcore HF16 very soon.
Arrayit should have been instead at the ASCO (American Society of Clinical Oncology) coference in Chicago. As you mentioned there have been many presentations there about targeted therapies and cancer diagnostics tests. All the presenters there have had excellent coverage in the media. Here is an example about one of them from TIME magazine which also has appeared in other media outlets. One interesting concept is that this particular blood-based diagnostic test including all of these markers could pick up a wide range of different types of cancers at the earliest stages. I suppose this way you don't have to have a bunch of cancer specific tests.
A Blood Test for Cancer?
Posted by Alice Park
Monday, June 7, 2010 at 4:16 pm
Any cancer doctor will tell you that the earlier you pick up a tumor, the better your chances are of treating it and getting it under control.
So researchers at the annual meeting of the American Society of Clinical Oncology in Chicago are announcing some welcome news on that front. Scientists at the biotechnology company Chronix Biomedical presented some intriguing data on a test they developed for picking up—in the blood—early stage breast and prostate cancers.
The test is based on the idea that tumors are constantly dividing and shedding dead tissue. The test is able to detect very specific fragments of DNA released by these dead cancer cells in the blood stream. So far, the company's CEO, Dr. Howard Urnovitz, says that the fragments are 92% sensitive in picking out the two cancers. And because the genetic signatures are unique to each tumor type, the test is also 100% specific for them. The advantage of such a blood-based diagnostic is that taken together, a test including all of these markers could pick up a wide range of different types of cancers at the earliest stages.
Such gene-based tests for diagnosing and even treating cancers is the latest trend in cancer therapy. For breast and colon cancer patients, a multi-gene test called can predict a patient's chance of recurrence once he or she has been diagnosed; the breast cancer version can also help guide patients and physicians to the right chemotherapy drugs.
So far, Chronix has only applied its test to samples of breast and prostate cancer tissue, and have yet to validate their test with the blood of actual cancer patients. That study is being planned, but Urnovitz is “cautiously optimistic” that it will confirm the findings in the tissue samples.
Let's wait and see what they tell the investors today.
This was announced by Arrayit in Dec 2009, correct?
However, in your post # 780 you quoted Dr Schena saying this:
January 08, 2010
"OvaDx was developed completely in house, Schena said, and is based on a different set of biomarkers than those discovered by Wayne State University researchers for detecting early-stage ovarian cancer and licensed by Arrayit. Last month, the company said that it is partnering with the university scientists to further develop those biomarkers into a microarray-based diagnostic."
Are they working with two sets of biomarkers?
Video of the Sat Jun 5th 15 min Arrayit presentation will post on the SCIA website 48 hours after the event as well as on the Arrayit home page. So, sometime Monday we should be able to watch the presentation.
You would think they would put out a snazzy press release just ahead of the conference to dazzle the investors. There is always tomorrow...
Abbott Receives FDA Clearance for New Ovarian Cancer Test.
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.earthtimes.org/articles/show/abbott-receives-fda-clearance-for-new-ovarian-cancer-test,1328555.shtml
Quest has a HE4 monitoring test that was approved by the FDA in 2008. So I'm not sure why Abbott's press release says that this is "the first automated test of its kind available in the United States". There must be some difference between the two tests.
Abbot submitted application to FDA in Feb 2010. The FDA approved it rather quickly.
Last update Feb. 5, 2009 ?? And all it says is that
Health Discovery Corporation (OTCBB:HDVY), a molecular diagnostics company, today announced that it has licensed rights to develop a new urine-based test for clinically significant prostate cancer to Quest Diagnostics Incorporated.
Does this mean that because of the license with Quest, they can not give out any information of when the test will become available?
"Keep in mind that prostate isnt the only ACE up the sleeve"... But isn't that test the one farthest along in development?
Ok I got it. I do see a lot of good info in the Ibox. But I did not see anywhere a timeline or estimated date of when the prostate cancer test would be launched. i.e available to doctors to use it.
Thanks Bob. Not sure what you mean by Ibox
Another prostate cancer detection study mentioned today at the American Urological Assn. in San Francisco
Dogs can potentially sniff out prostate cancer, French researchers say
June 1, 2010 | 2:00 pm
Man's best friend may cement his position if early results from French researchers can be replicated. A team of researchers from Tenon Hospital in Paris reported Tuesday at a San Francisco meeting of the American Urological Assn. that dogs can be trained to detect the characteristic odor of unique chemicals released into urine by prostate tumors, setting the stage for a new way to identify men who are most at risk from the cancer. If developed, the test might be more effective than the PSA test now used because it would have fewer false positives.
As surprising as the idea might sound, other researchers have already been studying the use of dogs to detect cancers of the breast, lung and bladder. Many tumors release characteristic chemicals that can be identified by the exquisitely sensitive canine nose. Lung cancer cells, for example, can release such chemicals into the air of the lungs, and they can then be detected on the victim's breath.
Dr. Jean-Nicolas Cornu of Tenon and his colleagues trained a Belgian Malinois — a shepherd breed that has already been used for detecting bombs and in other cancer tests — to identify urine from patients with confirmed prostate cancer, then to differentiate those samples from urine from healthy subjects. Finally, they used one urine sample from a prostate cancer victim and four samples from healthy people, asking the dog to choose the correct one. In 66 tests, the dog was correct 63 times. There were three false positives and no false negatives. That is, the dog correctly identified all the specimens from prostate cancer patients, but misidentified three from healthy men.
The whole training process took about a year, Cornu said, and the team is already training other dogs. The researchers are now attempting to identify what specific chemicals the dog is reacting to in hopes of developing an "electronic nose" that wouldn't require treats and potty breaks.
— Thomas H. Maugh II
I'm new to this board. Does anyone know the status of HDVY's commercialization of their prostate cancer test? Are they close to launching their product? Does the product have a name?
Today (6/1) it was reported in the news that "A urine test can help doctors better spot prostate cancer than either the current blood test or a rectal exam alone, U.S. researchers reported on Tuesday."
They said Gen-Probe's Progensa PCA3 test caught about half the actual cases of prostate cancer in men who had abnormal PSA levels or digital rectal exams, and had about a 20 percent "false positive" rate.
http://www.reuters.com/article/idUSTRE6505ZS20100601
From what I have read about HDVY's test, their new gene-based molecular diagnostic test for prostate cancer achieved a Sensitivity of 90% for correctly identifying the presence of Grade 3 or higher prostate cancer cells, and a Specificity of 97% for correctly identifying non-cancer cells (normal and BPH), representing an overall test accuracy of 93.
In light of the much better results form HDVY why are we still hearing news about how "good" Gen-Probe's Progensa PCA3 test is?
It could be that they are bringing this unreliable product to market to try to fill the vacuum, since no early detection tests are available. This may work for them for a while until better products (like Arrayit's ?) come along. Or if the FDA steps in to stop them.
Good analysis Silver. I'm surprised that EarlyCDT-Lung™ will be launched nationally in the USA this month considering it has not been approved by the FDA.
Oncimmune plans to adapt this technology to the development of blood tests for a variety of solid tumor cancers. The next test to follow EarlyCDT–Lung™ to the market will be a blood test to aid in early detection of breast cancer. The EarlyCDT–Breast test is in advanced stages of development and will be launched in 2011.
In addition to the EarlyCDT–Breast test, the company has also completed proof-of-principle studies on other tumor types (e.g., ovarian, esophago-gastric, colon and liver cancers) and plans to start validation of tests for these other types of cancer over the next two years.
Presentations on the technology are due to be made at the American Society of Clinical Oncology’s annual conference in Chicago next week. The same conference where the MD Anderson ovarian cancer study is being presented. IMO Arrayit should have presented their technology there also.
Arrayit's OvaDX is still kind of a "black box" test. It should be superior but we don't know too much detail about it. Have they ever identified the 100 biomarkers that they use? Also the clinical data is scant. Hopefully it all will become more clear when they apply to the FDA and present the data.