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I was referring to the methodology for their retrospective and prospective in vitro clinical trials that they are conducting. How are they doing them and how long are the trials expected to take.
Bart, let's hope that OvaDx comes to market soon so that other women don't have to suffer as you wife did.
Bart, yours is a very good assessment. It'd be nice if Arrayit discussed their methodology a little more.
Right after the 8/23 PR that you posted, Mark did an interview with genomeweb where they said this:
"Schena said that the company is conducting a retrospective trial using 500 patient samples, and then validating those findings in a 2,000-patient prospective, blinded trial."
The great unknown is how long these trials are expected to take.
I don't know what is driving the recent market interest and spike in pps. Maybe people are finally realizing that the pps was way undervalued at 0.16 to 0.20 trading range for the past few months.
Provectus Targets Analysts at Biotech Conference
The full-day conference will be held on November 30, 2010 from 8:30 a.m.–4:40 p.m. at 1540 Broadway, Suite 1010, New York, NY 10036.
Provectus Pharmaceuticals, Inc. (OTC-BB: PVCT), a biotechnology company focused on developing cancer and psoriasis treatments based on the Rose Bengal compound, similar to companies like Dendreon Corporation (Nasdaq: DNDN) and AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO), is targeting securities analysts at the 14th Annual Biotech and Specialty Pharma Conference later this month.
C-level executives from eight biotechnology companies will discuss their plans to invent, develop, research, and market important new drugs, diagnostics, and delivery technologies at the New York Society of Security Analysts’ 14th Annual Biotech and Specialty Pharma Conference on November 30, 2010. The companies’ developments range from oncology to dermatology therapies. George Fulop, MD, managing director at Stuyvesant Capital Management, will discuss the outlook for the biotech and specialty pharma industry.
After a strong recovery in 2009, investment performance in the biotech industry is mixed these days, with small-cap companies generally outperforming the large-cap stocks. The NASDAQ Biotechnology Index (NBI), the broadest measure of biotech sector performance, is essentially flat for the year compared to a 1% drop in the S&P 500. The Amex Biotechnology Index (BTK) is up 18% for the year. M&A activity is expected to rise in the coming years due to stunted growth in the big pharma market, which is projected to hold at 5–8% through 2014 because of drugs that are coming off patent and will be facing generic competition.
Some of the most innovative small- and micro-cap companies will present at the conference:
• ADVENTRX Pharmaceuticals, Inc. (NYSE, AMEX: ANX)
• Anika Therapeutics, Inc. (NASDAQ:ANIK – News)
• Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC – News)
• DARA BioSciences, Inc. (NASDAQ:DARA – News)
• EpiCept Corporation (NASDAQ:EPTC – News)
• GenSpera, Inc. (OTCBB:GNSZ.ob – News)
• Polymedix, Inc. (NYSE:PYMX – News)
• Provectus Pharmaceuticals, Inc (OTC:PVCT.ob – News)
• Senesco (NYSE, AMEX: SNT)
• SuperGen (NASDAQ:SUPG – News)
The full-day conference will be held on November 30, 2010 from 8:30 a.m.–4:40 p.m. at 1540 Broadway, Suite 1010, New York, NY 10036.
For more information on the conference, please visit: www.nyssa.org/biotech.
There is no charge for press with credentials.
About NYSSA
The New York Society of Security Analysts (NYSSA) is a leading forum for the investment community. NYSSA’s mission is to promote best practices and the highest professional and ethical standards in the industry. With over 10,000 members, NYSSA is the largest of the 135 societies worldwide that make up CFA Institute, which has more than 100,000 members.
PV-10 Melanoma Drug Trial Enrolls Patients in Compassionate Use Program
PV-10 is an injectable form of Rose Bengal, a small molecule staining agent used to assess eye damage and liver ailments. Provectus determined that the drug selectively kills cancer cells and has been studying it in nonvisceral cancers.
Under the compassionate use program, patients who are not eligible for clinical trials and have certain breast cancers, basal cell carcinoma, squamous cell carcinoma, certain head and neck cancers, and melanoma can receive PV-10, the company announced.
Phase II studies of PV-10 in metastatic melanoma have just been completed, and 10 of the patients from the study joined the compassionate use program.
Patients in the program will have more frequent and extensive treatment over a longer duration than did those who received the drug in the phase II studies. The company hopes that the compassionate use program might help pinpoint a dosing regimen that can be used in a phase III trial in metastatic melanoma.
Provectus will also pursue the study of PV-10 for liver cancer.
http://www.internalmedicinenews.com/news/oncology-hematology/single-article/pv-10-melanoma-drug-trial-enrolls-patients-in-compassionate-use-program/3aa5c7f126.html
Third quarter 10-Q form submitted today.
http://biz.yahoo.com/e/101115/aryc.ob10-q.html
Paid promotion for Mabcure. The technical message about MBCI sounds good, but with all the hype about getting rich presented here I'm not sure if this is the right way to get the message out about he company.
http://www2.smallcapfortunes.com/mabcure/index.html
More good news from Mabcure
MabCure Generates Tumor Specific Antibodies Against Prostate Cancer Which Could Lead To A Blood/Urine Diagnostic Test For Prostate Cancer
http://www.thestreet.com/story/10915165/1/mabcure-generates-tumor-specific-antibodies-against-prostate-cancer-which-could-lead-to-a-bloodurine-diagnostic-test-for-prostate-cancer.html
Don't see Arrayit in this report of Diagnostic Companies that received grants from the IRS. Wonder why.
"Proteomics Firms Net More than $8.75M in IRS Funds; Bulk of Awards Aimed at Diagnostics Work
November 05, 2010
http://www.genomeweb.com/proteomics/proteomics-firms-net-more-875m-irs-funds-bulk-awards-aimed-diagnostics-work
By Adam Bonislawski
Proteomics firms received more than $8.75 million in grants and tax credits awarded this week through the Qualifying Therapeutic Discovery Project Program, an initiative created by the Patient Protection and Affordable Care Act.
Based on the grant descriptions, a large proportion of the money, which is being provided by the Internal Revenue Service, will go toward diagnostics research, with a number of prominent proteomics-based diagnostics developers among the awardees.
Clinical proteomics firm Somalogic received one of the largest awards — worth more than $1.9 million — to fund a series of projects including development of protein-based diagnostics for non-small cell lung cancer, ovarian cancer, pancreatic cancer, and chronic kidney disease. The company has partnered with Quest Diagnostics to commercialize the pancreatic and lung cancer tests, with a laboratory-developed version of the lung cancer diagnostic slated for launch next year and a US Food and Drug Administration-approved version planned for 2012. It has begun a roughly 400-patient validation trial for its pancreatic cancer diagnostic, which it plans to complete within a year (PM 10/15/2010).
Also included in the $1.9 million award was $244,479 for research into the development of an inexpensive multiplexed blood-based diagnostic platform capable of testing multiple diseases.
Diagnostics company Biodesix, whose CEO David Brunel is a co-founder and former president of Somalogic, also received one of the larger awards — $1.4 million. Of that funding, $244,479 will go toward the company's VeriStrat protein-biomarker test, which launched commercially in May 2009 as a companion diagnostic to identify lung cancer patients likely to benefit from epidermal growth factor targeted therapy.
This June, Jennifer Hedrick, senior director of marketing at Biodesix, told ProteoMonitor that the company was looking to expand use of VeriStrat to other diseases, including colorectal, head and neck, and pancreatic cancer (PM 06/25/2010). The QTDP award is for research into the use of VeriStrat for guiding EGRF inhibitor therapy in cancer generally, suggesting that it will be used as part of these efforts.
The award will also fund research into the company's CancerDetect test for the early detection of lung cancer as well as the development of mass spec-based diagnostics for prostate cancer, inflammatory colitis, and autoimmune liver disease.
Seattle-based Integrated Diagnostics received $733,437 for research into tests for the early detection of lung cancer and Alzheimer's disease. In July, the company secured $10 million in private funding, which it said it would use for verification studies to establish clinical feasibility for protein biomarker panels for at least one, and possibly both, of these diseases (PM 08/06/2010).
Quanterix also received $733,437 through the QTDP. The company will use the award to fund research into a blood-based diagnostic for Alzheimer's disease, a companion diagnostic to predict response to Crohn's disease therapy, and the development of its single-molecule array technology for monitoring the recurrence of prostate cancer.
In June, David Duffy, the company's senior director of platform research, told ProteoMonitor that it plans to launch the prostate cancer diagnostic as a laboratory-developed test in 2011 and to bring the Alzheimer's diagnostic to market in 2012 (PM 06/11/2010).
Diagnostics firm Vermillion, which launched commercial sales of its OVA1 protein biomarker-based ovarian cancer test in March, received $488,958 through the program for the development of OVA2 — an expanded version of OVA1 — and Vasclir, a biomarker blood test for peripheral artery disease. During its second-quarter earnings call in August, Eric Fung, Vermillion's chief science officer, cited those diagnostics as the primary focus of the company's current R&D efforts (PM 08/13/2010).
Correlogic Systems received $244,479 for work on multivariate protein-based assays for ovarian and breast cancers. An increased emphasis on breast cancer diagnostics would mark a shift for the company, which over the last decade has focused primarily on its ovarian cancer test OvaCheck. Correlogic filed a 510(k) application for OvaCheck with FDA in December of 2008 but withdrew it in April after being told that the patient population used in the clinical trial for the test was not satisfactory, and is currently undertaking the "second arm" of the trial, upon completion of which it plans to file another 510(k) submission.
In July, the company filed for Chapter 11 bankruptcy, and in October was granted the right as part of its restructuring to reject OvaCheck licensing agreements with Quest Diagnostics and Laboratory Corporation of America (PM 10/08/2010).
Insilicos, which in October used a $1.2 million Small Business Innovation Research grant to launch a 400-subject study evaluating its protein biomarker-based cardiovascular disease diagnostic PreClue, received an additional $244,479 to fund the development of the test (PM 09/24/2010). Other companies winning grants for diagnostics work include Predictive Biosciences, which received $488,958 for bladder cancer prognosis and recurrence tests; Astute Medical, which received $244,479 for the development of a biomarker panel for the early detection of acute kidney injury; and Theranostics Health, which was awarded $244,479 for molecular diagnostics aimed at guiding therapies for metastatic cancer patients.
Proteomics tools and assay development projects also received funding through the program, although at a considerably lower level than diagnostics work. Cell Biosciences received $244,479 for the development of its nanoimmunoassay platform, which has recently shown utility as a tool for studying protein phosphoisoforms (PM 10/15/2010). Tools company BioScale was awarded $244,479 to continue work on its Acoustic Membrane Microparticle protein detection system (PM 06/18/2010). And biotech firm Prognosys Biosciences received $66,428 for research into methods of mapping protein kinase activity across the proteome.
Pressure Biosciences won $244,479 to continue development of its pressure cycling technology, which the company has been marketing as a tool for mass spectrometry sample prep and extracting proteins from formalin-fixed paraffin embedded tissues, a common form of tissue sample.
CytoScale Diagnostics, a start-up formed this April by recent graduates of the University of California, Los Angeles, MBA program, secured $244,479 for the development of circulating tumor cell cancer diagnostic devices. In May, the company signed a letter of agreement with the Regents of the University of California to exclusively license a chip-based microfluidic image-cytometry platform developed by a team of UCLA researchers and capable of detecting proteins in samples as small as 1,000 cells (PM 08/06/2010).
At the June 2010 investors conference Arrayit said that in addition to OvaDX the following tests were in the pipeline but that they needed money (millions of dollars) to bring them to market:
VIP for Plavix Estimated Revenue $900M
Parkinson's disease Est. Revenue $500M
Prostate cancer Est. Revenue $1.5B
Regarding the Parkinson’s test, Dr. Schena has discovered a set of biomarkers that could diagnose Parkinson’s 20 years before symptoms appear. Arrayit has been conducting experiments with the biomarkers in collaboration with the The Parkinson's Institute of Sunnyvale, California (June 2009 press release)
A few months ago the Michael J Fox Foundation for Parkinson’s Research announced a $40 million initiative called PPMI. (Parkinson’s Progression Markers Initiative) to study to identify biomarkers of Parkinson’s disease progression. Arrayit is well aware of this initiative, and hopefully the PPMI will use the Arrayit Parkinson's test kits in the study.
On October 14, 2010 San Jose Mercury News reported the following (too bad they do not mention Arrayit’s collaboration with the Institute in Sunnyvale):
“Sunnyvale will soon be the California epicenter of one of the largest Parkinson's disease research studies, as the Michael J. Fox Foundation has named the Parkinson's Institute and Clinical Center one of 18 research centers in its Parkinson's Progression Markers Initiative (PPMI). The Sunnyvale site is the only one chosen for the study in California, and one of three on the West Coast.
The $40 million, five-year study sponsored by the Fox Foundation founded by actor Michael J. Fox, who has Parkinson's disease, will attempt to identify biomarkers of the disease in newly diagnosed patients. The Parkinson's Institute will study 20 patients and 10 control subjects over the next five years, and will team with El Camino Hospital for state-of-the-art neuroimaging services.
"To date, we don't have any drug that will slow or stop the progression of this disease in patients," Parkinson's Institute director of clinical research Dr. Caroline Tanner said. "We desperately need something that will more precisely allow us to measure disease progression. This is the first study that systematically sets out to identify a biomarker for Parkinson's."
Tanner said she is not sure of the exact reasons the Parkinson's Institute was chosen for the study, though she speculates it is partially because of Sunnyvale's prominence in Silicon Valley and the institute's strong reputation.
"We're kind of a unique place in that we focus on research as well as patient care," Tanner said. "We have more than 3,000 visits a year from people with Parkinson's disease, and we've been active in studying and implementing new treatments."
According to the Michael J Fox Foundation website:
“The Parkinson’s Progression Markers Initiative is is an observational research study to identify biomarkers of Parkinson’s disease (PD) progression. A biomarker is a substance or characteristic in our bodies that is associated with the presence of disease, or that changes over time in a way that can be linked to the progression of disease. An observational study means that study participants will undergo numerous tests and assessments of bodily processes related to PD, but will not receive an experimental drug or treatment. This study will use a combination of imaging techniques, collection of blood, urine, and spinal fluid, and clinical tests.
The information gathered from these procedures is critical to the future development of new and better treatments for Parkinson’s disease. PPMI is the first clinical study to assemble a population of sufficient size to collect this information, draw meaningful scientific conclusions over time, and try to develop better ways to measure the progression of PD.
The study will be conducted in the United States and Europe. It is expected to take about five years. The goal of the PPMI study is to identify one or more biomarkers of Parkinson’s disease.
PPMI requires the participation of 400 Parkinson’s patients who are newly diagnosed and are not currently taking standard PD medications and 200 individuals who do not have PD. Participants must be at least 30 years of age. They will be enrolled at about 18 Parkinson’s disease centers — 14 across the United States and 4 in Europe — over approximately two years.
http://www.michaeljfox.org/living_PPMI_overview.cfm
MabCure Inc (OTC:MBCI) Records A Massive Buying Wave
Oct 7,2010
http://www.hotstocked.com/article/3026/mabcure-inc-otc-mbci-records-a-massive-buying.html
Yes, that's encouraging. And the trend is continuing today, up 20% more.
Your last call on 8/4 (Post 1074) was "...54 to 1.00 in days imo.. possibly more.."
DID NOT HAPPEN !! Why should anyone believe you now.
Transparency and keeping shareholders informed is the key.
MBCI up 10% today to 0.605
ARYC down 10% today to 0.17
This synopsis of Arrayit appeared today at Instrument News (United Kingdom). They say ARYC management issued a press release introducing the company’s financial report for the second quarter of calendar 2010. Not sure if I saw that PR:
Arrayit continues to look for funds
Arrayit Corp (Sunnyvale, CA), a developer of proteomic biomarker diagnostics on the basis of microarray technology, continues to be “hampered by its lack of financing”, management said in the press release introducing the company’s financial report for the second quarter of calendar 2010. The company recently installed its proprietary microarray platform at the National Institute of Mental Health, in Rockville, MD, part of the National Institutes of Health, and presented its premarket approval submission strategy for its OvaDx® platform for the diagnosis of pre-symptomatic ovarian cancer.
In the three months ended on the 30th of June 2010, the company had sales of just over $790,000, down a third from Q1 2009. Net loss for the period was $1.2 million, compared to just over $2,000 the previous year. For the first half of the year, revenues were at $1.5 million, a 32% decrease compared to the same period in 2009, while net loss jumped to $1.8 million from a mere $104,000 a year earlier.
Founded in 1993 by Rene Schena and Todd Martinsky, currently Arrayit’s CEO and executive vp, respectively, as Telechem International, a chemical import/export company, Dr Mark Schena (Arrayit president) and Paul Haje joined In 1999 to found the microarray subsidiary Arrayit Life Sciences. Since the company became publicly-listed in March last year through a reverse merger with Integrated Media Holdings, its shares’ evaluation have enjoyed only a few months above the $1 threshold.
Telechem and PerkinElmer acquistion Pediatrix Medical Group have been engaged in court cases about alleged breaches of contracts, fraudulent misrepresentation and misappropriation of trade secrets (see IN 2 (6) 5; online 18/5/10).
More stories on LIFE SCIENCES, NEWS | September 26, 2010 | 0
http://instrumentnews.co.uk/2010/09/arrayit-continues-to-look-for-funds/
Admiral, not sure why ARYC keeps everything so secret, but the market is punishing the stock price because ARYC is not being more open with information. You wrote to Mark a couple of months ago and I did the same to try to get them to be more open. All we got is "stay tuned for important announcements". We are still waiting.
Mum is the word from ARYC as to when they will submit the PMA application to the FDA.
Yeah, one tells friends and family about ARYC, and they buy the stock. Then the price falls off a cliff like it has been doing in the past few months. One would not be too popular.
I started buying in Feb 2010 at 1.22 when the ARYC Press Releases were giving guidance of all the wonderful things coming up. So far they have not materialized. I bought at many lower price points thinking they were the bottom. But ARYC never ceases to amaze about going yet lower. Today it hit a low of 0.19 again.
ARYC stock is so risky that you need a steel stomach to invest in it.
That being said, in the "10 ways to make real money" in Sept issue of Money magazine they say the following which rings true about value investing:
"Emotional markets typically create profitable anomalies"...
"Investors should let valuations be their guide. In other words the key to stellar long-term profits is to buy cheap - that is to uncover the real bargains before the rest of the world catches on"...
"of course cheap is cheap for a reason and carries more risk. Not all the picks are poised for a quick turnaround, some may fall even more before hitting bottom. But because it is impossible to tell just when that low point will be, and the only certain thing is that they are cheap today, now is the time to buy"
"if you want to plump up your returns with money you can afford to risk"....they go on to make recommendations among them to invest in some Health Care Stocks that are down.
One can only hope that ARYC falls in this category and one day soon thay get their act together and deliver on their promises.
The FDA is leaning to more regulation of tests not less.
Labcorp tried to convince the FDA a couple of years ago that their Ovasure diagnostic test was an LDT which did not need FDA approval, but the FDA did not buy that. The FDA asked Labcorp to conduct clinical trials and submit application. Their trials are in progress now.
Since ARYC is going to submit OvaDx as a screening test for the general population, ARYC is following the right strategy by going the more stringent PMA route with the FDA.
More on the FDA current thinking appeared on Sept 14 in the New York Times:
http://www.nytimes.com/2010/09/14/health/14kelsey.html
The Public’s Quiet Savior From Harmful Medicines
"For much of the past two decades, the F.D.A. has emphasized speed over certainty in its decisions — an industry-friendly stance that plays down safety concerns in favor of getting potential cures to the market as swiftly as possible.
But a series of drug, medical-device and food-safety controversies have led some agency medical officers to insist on better information before approving products and to lobby internally for risky products to be pulled from the market, putting the speed-oriented old guard on the defensive. A celebration of Dr. Kelsey, the patron saint of the agency’s safety-first faction, is bound to cheer those calling for greater caution"
I read the following interesting article in the May 2009 issue of DDN (Drug Discovery News). I got a sense of deja vu when I read the last paragraph.
“Parkinson’s,” he (Schena) says, “is a road map for elucidating all human disease.” Asked about a timeline, he demurs, but then adds, “We expect to have a major announcement soon.”
----------------------------------------------
http://www.drugdiscoverynews.com/index.php?newsarticle=2965
The ‘father of microarrays’ attacks Parkinson’s
SUNNYVALE, Calif.—Dr. Mark Schena, who along with Ron Davis authored the first published paper on DNA microarrays (Science, 1995), has led his company, Arrayit Corp., into a research partnership with The Parkinson’s Institute to discover biomarkers for Parkinson’s disease. The unique study involves the prospective collection and analysis of samples from well-characterized Parkinson’s patients using Arrayit’s new H25K microarray technology.....
Re: "The larger picture here, and something we have addressed publicly, is that the Arrayit platform offers greater specificity and sensitivity for disease analysis than any other platform in the world."
I want to believe, but we can only take Arrayit at its word here. Where have they publicly addressed the greater specificity and sensitivity? Where are their studies results to be compared to other platforms?
Hey Bill, thanks for sharing the response form Mark. When he says "each of these projects is moving forward very nicely", which ones ones did you ask him about?
That's so funny. But don't feel bad, they don't always answer.
Unfortunately, we won't know what Arrayit's method is until they disclose it. And up to know getting info out of them is like getting the proverbial blood from a turnip.
I don't know much about level II either, but from what I can tell, the transactions shown in red (pink) means that the trade was at a price LOWER than the previous trade. The ones in green at at a price HIGHER than the previous. And the ones in white at the SAME price. I don't know how to tell the ones sold at the ask/bid. Or which ones are buy or sell.
I came to know about ARYC last year while researching MBCI (Mabcure). MBCI was back then in early stage development of their promising ovarian test. According to what I read then about ARYC, ARYC was in late stage development of OvaDx. So to hedge my bets, I started investing also in what I thought was the leading horse. Now I’m not so sure which horse is leading.
MBCI has been much more transparent in what they are doing. Notice their various press releases over the last couple of months. MBCI uses the top notch Zeno Group as their PR firm. They explain their retrospective study using a library of stored blood samples in a hospital in Belgium. In a sample blinded study of 54 blood samples, MabCure’s MAbs correctly diagnosed 16 of the 17 ovarian cancers with a diagnostic sensitivity of 94 percent and 100 percent specificity. They explain their various ongoing clinical trials in Thailand and Europe and what other trials they have in store. The Thai National Cancer Institute just joined Mabcure's Ongoing study in Thailand. MBCI recently filed a provisional patent application for its ovarian cancer antibodies with the U.S. Patent and Trademark Office. The antibodies they use are also being explored to deliver drugs to treat the cancer without damaging surrounding tissue. MBCI does not have any income as they do not have any products to sell yet. Still the MBCI pps has risen since their PR’s to a much higher level than ARYC.
I wrote to Mark a couple of weeks ago suggesting that ARYC follow MBCI’s example and to consider making public the progress of ARYC’s diagnostic tests. He thanked me saying it was a good idea and to stay tuned for future important announcements. The announcement they made about PMA path was not quite transparent as it generated more questions than answers. And the interview with genome web gave some info but managed to muddy the water at the same time.
So whether ARYC or MBCI is the leading horse is not so clear anymore due to ARYC’s lack of transparency. And as Silver has pointed out in many occasions the stock market does not reward silence as it creates suspicion that they are hiding something.
July 27,2010
MabCure, Inc. Announces Positive Results for New Ovarian Cancer Diagnostic Blood Test
http://www.businesswire.com/news/home/20100727006046/en/MabCure-Announces-Positive-Results-Ovarian-Cancer-Diagnostic
June 1, 2010
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure’s Chief Executive Officer
http://www.businesswire.com/news/home/20100601005471/en/Memorandum-Shareholders-Dr.-Amnon-Gonenne-MabCure%E2%80%99s-Chief
August 17,2010
Thai National Cancer Institute Joins Mabcure's Ongoing Study in Thailand
http://www.tradingmarkets.com/news/stock-alert/mbci_thai-national-cancer-institute-joins-mabcure-s-ongoing-study-in-thailand-1116106.html
August 3,2010
MabCure, Inc. Files Provisional Patent in the U.S. for Ovarian Cancer Antibodies
http://www.businesswire.com/news/home/20100803005685/en/MabCure-Files-Provisional-Patent-U.S.-Ovarian-Cancer
Hey Bart good to hear from you. You haven't posted here in a while.
According to Genomeweb, Arrayit is doing both types of studies.
"Schena said that the company is conducting a retrospective trial using 500 patient samples, and then validating those findings in a 2,000-patient prospective, blinded trial." It sounds along the lines of what you describe.
It would be nice if Arrayit gave more details about what they are doing and for how long they plan to conduct their studies.
See some definitions below. A prospective study could take a long time. Some people did a prospective study on CA-125 and it took 10 years.
Prospective vs. retrospective studies
Prospective
A prospective study watches for outcomes, such as the development of a disease, during the study period and relates this to other factors such as suspected risk or protection factor(s). The study usually involves taking a cohort of subjects and watching them over a long period. All efforts should be made to avoid sources of bias such as the loss of individuals to follow up during the study. Prospective studies usually have fewer potential sources of bias and confounding than retrospective studies.
Retrospective
A retrospective study looks backwards and examines exposures to suspected risk or protection factors in relation to an outcome that is established at the start of the study.
Other sites are reporting genome web's first paragraph:
8/24
Arrayit said this week that it has submitted an application for premarket approval with the US Food and Drug Administration for its OvaDx Pre-Symptomatic Ovarian Cancer Screening Test
http://www.drugtestexpert.com/?p=2698
-----------
On 8/23 (see below) Genome web had a different spin than on 8/24 after talking to Schena.
August 23, 2010
By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Microarray firm Arrayit today said that it will be seeking pre-market approval by the US Food and Drug Administration for its OvaDx ovarian cancer test.
In a statement, the Sunnyvale, Calif., firm said that though the PMA process is more stringent than the 510(k) route, it believes it can receive Class III PMA approval for the test.
"We have carefully considered the technical and regulatory issues with respect to OvaDx and have decided that a PMA submission, though more demanding that a 510(k0K, is the most appropriate pathway to market for our ovarian cancer screening test," said Arrayit CEO and Chairman Rene Schena in a statement.
The FDA regulates in vitro diagnostic devices under three classes. Class I devices are considered the least risky and subjected to pre-market 510(k) notification, while Class II devices are considered to be riskier than Class I products and are subject to pre-market 510(k) approval. Class III devices are considered the riskiest and subject to PMA.
The OvaDx test is based on Arrayits proprietary microarray platform to identify about 100 protein biomarkers in serum and detect ovarian cancer as early as five years in advance of any symptoms, the company said.
Arrayit did not say when it would be filing its application with the FDA.
Thanks for the article. First time we read any info about the clinical trials. It seems they are opening up a little bit.
That was my first reaction when I read the article! The article said that the application was submitted already. Re-reading Arrayit's PR, they talk about submission in the present tense NOT in the future tense and the fact they did not mention any dates in the PR is kind of interesting. And you said that John would not discuss dates. It is kind of the game the U.S. had to play during the Cold War trying to decipher what the Russians were up to by looking at whatever little info they could get from cryptic Russian speeches and photos. (and John is talking about spies to boot)
But still it would be great if indeeed they had submitted the application. Although they are talking about on going trials. Do all trials have to be finished before submission?
But betweeen the article and your conversation with John we sure know a lot more today than yesterday.
P.S Thanks for sharing the results of your communication with Rene and John.
ALL this stuff you are regurgitating was already posted long time ago and known by you (i.e old news) when on 8/3 you were pumping the stock. Obviously you are doing a lame job of stock manipulation.
Why should anyone believe your bipolar posts here? Did the party ever start? YOU were pumping this stock on 8/3
Your post today: STRONG SELL .01 target ..this party is OVER
Your post 1057 on 8/3: GO long ARYC .46 we have bottomed and are heading back over 1.00.. YOU WERE WRONG
Your post 1067 on 8/3 : accumulate all you can under .80.. i feel thats our next stop... YOU WERE WRONG
Your post 1069 on 8/3: mike u need to sell all of your stock.. you dont deserve whats to come.. weak hands sink ships. please sell.. one of us will gladly buy your stock here. yee of little faith. "always darkest before dawn"
Their science and results must be on a solid basis for them to choose this route. In addition contract research organization DOCRO is advising them regarding FDA approval. "DOCRO has steered nearly 100 In Vitro Diagnostic (IVD) clinical trials through the Food and Drug Administration in the past 12 years, along with 39 pre-market approval (PMA) and 46 510(k) applications. DOCRO has an unparalleled 99% success rate with the FDA." (from 3/22/10 press release)
You're right, the one missing key information is any projected date for PMA submision.
Arrayit Corporation Announces Premarket Approval (PMA) Submission Strategy for OvaDx(R)
http://www.globenewswire.com/newsroom/news.html?d=199862
------------
Don't know if that is good news, but at least they are talking strategy.
United States Patent and Trademark official image of the OvaDx microarray kit (via a tweet from Arrayit on Sunday 8/22/10
http://bit.ly/cmGxx7
Sounds like a good idea. I hope they are reading this...or maybe you could email it to Rene.
More on the Georgia Tech ovarian test in this article from Proteo Monitor. They mention Arrayit's OvaDx in the list of tests being developed. Georgia Tech's test uses "at the minimum 2,000 to 3,000 features" (markers)
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Georgia Tech Team Claims 100 Percent Accuracy for Metabolomic Ovarian Cancer Test in Initial Trial
August 20, 2010
By Adam Bonislawski
A metabolite-based diagnostic developed by researchers at the Georgia Institute of Technology identified women with ovarian cancer with 100 percent accuracy in a recently published 94-subject trial.
Although additional, larger trials are required to validate the test, the initial results suggest it could be useful in screening high-risk patients for ovarian cancer and possibly even as a screening diagnostic for the general population, John McDonald, chief research scientist at Atlanta's Ovarian Cancer Institute and one of the paper's authors, told ProteoMonitor.
The fifth leading cause of cancer-related deaths among women, patients diagnosed in the disease's early stages have a greater than 90 percent five-year survival rate. Because early-stage patients are typically asymptomatic, however, ovarian cancer often goes undetected until its later stages. The five-year survival rate for these late-stage patients is roughly 20 percent.
There is need, therefore, for diagnostics capable of detecting ovarian cancer in its early stages, and the disease has been a primary focus of diagnostic development, with a variety of protein biomarker-based tests – including Vermillion's OVA1, Correlogic's OvaCheck, Healthlinx's OvPlex, and Arrayit's OvaDx – in some stage of commercialization.
According to McDonald, the prevalence of such protein-based ovarian cancer diagnostics was one of the main reasons the Georgia Tech group decided to look at the metabolome instead of the proteome for potential biomarkers.
"We wanted to get into something that was less crowded," he said.
He added that another potential advantage of the metabolomics approach is easier mass spectrometry analysis.
"Because the metabolome is much smaller than the proteome for mass spec analysis things are spread out better, so we get better resolution," he said.
The Georgia Tech test, which is described in the current issue of Cancer Epidemiology, Biomarkers, & Prevention Research, used direct-analysis-in-real-time mass spectrometry to measure thousands of metabolites in subjects' blood samples and then classified them with a functional support vector machine-based machine-learning algorithm.
The researchers evaluated the method via two different approaches. In the first – a 64-30 split validation – they used 64 of the subjects as an algorithm training set and the remaining 30 as an independent test set. Using this technique they achieved 100 sensitivity and 100 specificity.
In the second approach – leave-one-out-cross-validation, or LOOCV – the researchers used 93 of the samples as the training set and the remaining sample as the unknown, running the samples sequentially until each of the 94 had been measured as an unknown. With this method they classified all but one of the 94 samples correctly, for an overall accuracy of 98.9 percent – 100 percent sensitivity and 98 percent specificity.
McDonald was "quite shocked," by the results, he said. "I was expecting the metabolome not to be a good way to go because I thought metabolites would be highly variable. I was really surprised that we were able to get such accuracy out of it."
One thing contributing to the test's accuracy, McDonald said, is the large number of markers it employs.
"In ovarian cancer, the single protein that's commonly used [as a biomarker], CA-125, is not a very accurate test," he said. "The reason for that is that all cancers are variable. So if you're relying on a single biomarker, it's very unlikely that that single biomarker will be 100 percent accurate or even 99 or 95 percent accurate."
"Even going from one to five [biomarkers] increases accuracy tremendously. In our case we're using at the minimum 2,000 to 3,000 features. That should in theory give us an even higher degree of accuracy," he said.
By comparison, most protein-based tests that are commercially available or under development use a handful of markers. Vermillion's OVA1, for example, analyzes five protein markers, including CA-125. The HealthLinx OvPlex test also uses five proteins, including CA-125, and the company is currently evaluating two additional markers to add to the test (PM 6/18/2010).
Because of the low prevalence of ovarian cancer, screening tests need to be highly accurate to avoid a large number of false positive results. In fact, McDonald said, for a screening test to be useful for the general population it would need to demonstrate 100 percent accuracy.
The researchers used DART-TOF MS on a JEOL AccuTOF instrument to isolate the thousands of metabolomic features used in the test. Initially, they prepared the samples using conventional liquid chromatography, but realized that with DART they could get sufficient resolution without any separation steps.
"The problem with [liquid chromatography] is the time involved," McDonald said. "With the DART technique you don't have to do any sample preparation. You just put the sample in and it vaporizes and goes in. We know we lost some resolution going to [DART], but we're still getting 20,000 features, so we're well above what we need for diagnostic purposes."
Results from the 94-subject study suggest that the test could be useful in screening high-risk patients for ovarian cancer and possibly even as a screening diagnostic for the general population, a Georgia Tech researcher said.
http://www.genomeweb.com/proteomics/georgia-tech-team-claims-100-percent-accuracy-metabolomic-ovarian-cancer-test-in
Oh, no, he's back from the cruise and sent this brilliant tweet a few hours ago:
ArrayitDX
Good Morning
about 10 hours ago via HootSuite