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Another interesting thing, this study may be related to a request from the FDA to do so. In the meantime, Correlogic has filed for bankruptcy:
Correlogic regroups, files for Chapter 11
Friday, July 23, 2010
For the second time in a month, a Maryland bioscience company has filed for bankruptcy.
But unlike Cyto Pulse Sciences of Glen Burnie, which filed for Chapter 7 liquidation, Correlogic of Germantown has filed for Chapter 11 protection and plans to soldier on with its cancer test candidate.
The company, which develops software for blood assays that look at multiple biomarkers for cancer, recently won approval from European regulators for its OvaCheck early detection test for ovarian cancer. Executives are negotiating deals with European labs to use the test.
But domestically, the Food and Drug Administration has "moved the goal posts" on Correlogic, says CEO and co-founder Peter J. Levine. A year ago the FDA ordered more studies before approving the test for use in the U.S.
"The FDA issue was not about results of the trial — there were no questions about that — but an arcane issue of the clinical trial population," Levine said in an interview. "There was no question about the fact that it worked."
Correlogic now is conducting a "second arm" of the trial on a slightly different population to address the FDA's concerns.
"We're in the middle of that," Levine said. "Assuming we get funding, we're probably about six to eight months from resubmitting to the FDA. We thought we'd be to market a year ago."
The company has struggled for years with the FDA, partly over whether OvaCheck should be defined as a medical device, which would put it under the agency's purview.
"We're in the Valley of Death — that's what [the National Institutes of Health] calls it," he said. "We have a product, we've spent tens of millions of dollars, we've proven it, but we're in a regulatory tug of war. The FDA has been moving the goal posts. It can't make up its mind. I don't question their good faith, but when the agency twitches, it has ramifications for industry and ultimately the public."
The FDA's rejection last year forced the privately held company to tighten its budget. It cut its staff from 18 to 10 full-timers and two part-timers and moved from Rockville to the business incubator on Montgomery College's campus in Germantown.
It also decided to file for Chapter 11 bankruptcy protection last week.
The company lists assets and liabilities of $1 million to $10 million. Most of its debt is back pay totaling $1.1 million owed to its employees, including $414,663 to Levine himself.
That so many Correlogic employees have worked without pay is a "testimonial to the loyalty and professionalism of the staff," Levine said. "We've had very rough times over the last year, but the staff hung in there."
The Chapter 11 filing also allowed Correlogic to get out of two contracts that were hamstringing its research and development efforts, Levine said. One of the contracts was with one of the company's investors, Quest Diagnostics of Teterboro, N.J., which owns 2.89 million shares of B preferred stock, according to Correlogic's website.
On Monday, the bankruptcy court granted Correlogic's motion to reject those contracts.
"That was a strategic move," Levine said. "It gives us more flexibility in how our product goes to market. It makes it more likely to have other investors come in and opens a wider range of how you ultimately finance this last leg of the long journey to get to market."
http://www.gazette.net/stories/07232010/businew173130_32538.php
Meant to say: Hope to some day read similar details about the performance of OvaDx which up to now is shrouded in mystery
A study examining the performance of an 8 biomarker test for symptomatic women was done by Correlogic Systems, Inc (maker of OvaCheck). The study appeared in "Nature Precedings July 2010".
http://precedings.nature.com/documents/4667/version/1/files/npre20104667-1.pdf
Hope to some day read similar details about the performance of OvaCheck which up to now is shrouded in mystery.
I double checked in Amazon to be sure and the book is a novel. LOL
On the light side, while we wait to hear more news about OvaDx from Arrayit, here is a passage from a novel called Healer by Carol Cassella which will be published in Sept. I like the first part, the "riches" part (not so much the second "rags" part) :D
"Claire is at the start of her medical career when she falls in love with Addison Boehning, a biochemist with blazing genius and big dreams. A complicated pregnancy deflects Claire’s professional path, and she is forced to drop out of her residency. Soon thereafter Addison invents a simple blood test for ovarian cancer, and his biotech start-up lands a fortune. Overnight the Boehnings are catapulted into a financial and social tier they had never anticipated or sought: they move into a gracious Seattle home and buy an old ranch in the high desert mountains of eastern Washington, and Claire drifts away from medicine to become a full-time wife and mother. Then Addison gambles everything on a cutting-edge cancer drug, and when the studies go awry, their comfortable life is swept away. Claire and her daughter, Jory, move to a dilapidated ranch house in rural Hallum, where Claire has to find a job until Addison can salvage his discredited lab."
Neat picture!
The health insurance reform law, which President Obama signed into law in March, is expected to make preventive care more affordable for seniors....
Americans only use preventive services at about half the recommended rate, and that is thought to be the direct result of cost, including cost sharing (deductibles, co-insurance, or co-payments). Thus, beginning in January 2011, Medicare beneficiaries will not longer have to pay out-of-pocket costs for many preventive services, including an annual wellness visit with a physician.
...services which Medicare already covers can be provided free of charge to the patient, including: mammograms every 12 months for eligible beneficiaries age 40 or older, colorectal cancer screening, cervical cancer screening...Medicare will be able to add appropriate preventive services, tests or screenings, as they become available and are recommended by the U.S. Preventive Services Task Force. (www.ahrq.gov/clinic/uspstfix.htm).
Thus, the new focus on prevention is very important to the nation's seniors, many of whom do avoid care due to cost. It's estimated that if an older woman who is at risk from heart disease got a mammogram, a colon cancer screening, Pap test, diabetes test, cholesterol test, and a flu shot, under a typical insurance plan the out of pocket cost to the patient could approach $300.
http://www.gloucestertimes.com/lifestyle/x540034689/Health-reform-should-mean-more-services-at-less-cost
I was wondering the same thing. Spur of the moment I bought a few more shares at 0.50 thinking it was a good price, and then at the close it was trading at 0.45...Funny coincidence, my average cost is around 0.65 also, so we are in the same boat.
One stock to remember is Vermillion. VRML went bankrupt while waiting for FDA approval of OVA1 and its shares were selling for 0.05 in Sept. 2009...Once FDA approval came on 9/11/09 its shares started to go up an it reached a high of around $34. six months later.
If you had bought 100,000 shares of VRML at 0.05 when nobody wanted it, that $5000. would have turned into $3.4M. Being a contrarian paid off as usual.
I don't know if there are parallels to ARYC here. Was VRML better managed? VRML was in bankruptcy after all. ARYC is cash flow positive, and it does sell their microarray products, so its stock is worth something. Then if OvaDx gets approved you are talking serious money here.
This is a nice assessment of ARYC. It shows a lot of promise for the company if it comes to pass. I read it back in May. It came around the time of the infamous paid promotion that propelled the stock price to around 1.30. And the trade volume was in the millions of shares. But ARYC failed to keep the investors interest and momentum going.
That's good information. Thanks for the link to the publication. I was able to read the abstract. Do you know how to get to the full document?
Here is another interesting article
Scientists Criticize Study on Genetics of Old Age
The study, which received broad press coverage, said that 150 genetic variants predictive of longevity had been identified among New England centenarians and that a test based on those variants could predict who would live to extreme old age.
http://www.nytimes.com/2010/07/09/health/research/09age.html?scp=1&sq=scientists%20study%20on%20genes&st=cse
------------------
This is one of my fears about all the tests being developed to predict one thing or the other. The news gets thrown out to the public before the results have been verified. I hope that OvaDx and the other Arrayit tests live up to the expectations. I want to believe that I'm investing in something real.
That's a problem when they get ahead of themselves and announce that some future press release is going to follow later on and then they don't deliver them. As far as OvaDx I don't think we are going to hear anything new until they submitt the 510K to the FDA which is supposed to happen in the 3rd quarter 2010. It's anyone's guess if it will be July, Aug or Sept.
Another possible area for ARYC to get involved in:
UCL scientists discover how to switch cancer ‘protector’ gene on
http://www.ucl.ac.uk/news/news-articles/1007/10070104
A new UCL study has revealed that a gene that normally protects against ovarian cancer is switched off in two-thirds of cases and switching it back on arrests tumour growth....
OvPlex ovarian cancer test test by Healthlinx (Australia)comes under fire
http://www.theage.com.au/national/ovarian-cancer-test-comes-under-fire-20100704-zvth.html?from=age_sb
"Researchers and doctors say that only one study of OvPlex has been done and there is no data to show the test improves survival rates - and that it could create uncertainty and unnecessary surgery."
"It is important to note that no data on OvPlex have been reported from prospective controlled clinical trials and there is currently no evidence that OvPlex has any impact on ovarian cancer mortality."
-----------------
I hope that Arrayit's OvaDx clinical trials data, when it is unveiled, holds up under the scrutiny of doctors and researchers.
This is the pipeline (and the future of ARYC) we are talking about. OvaDx gets the chain reaction started. According to Mark Schena's projections:
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
About ARYC's Parkinson's screening test, Mark Schena said it could detect the disease 25 years before symptoms are present.
Delsurfer, OvaDx is the big deal, I'm putting all my hopes on it. They better get that approved, and marketed either alone or with a partner. They need that first big success story. And then on to the other tests: prostate, Parkinson's, etc. The PR made reference to these also.
Re: Howell's tweets, I hope he stays permanently silent. He gives the company a bad name. He should tweet his garbage from his own personal account not from ArrayitDx's.
These are his (ArrayitDx's) tweets from Monday 6/28
@starZship Thanks for the RT.
1:41 PM Jun 28th via web .
Prostate Cancer Patients Face Yearlong Rationing of Drug Provenge http://bit.ly/cLH9cq #ARYC
1:25 PM Jun 28th via HootSuite .Copy and Paste DNA - More Common Than Previously Thought http://bit.ly/cbVASQ #ARYC
11:00 AM Jun 28th via HootSuite .@ELNC @aussietorres @DonnaPetko @planetrussell Thanks everyone! Hope you all have a great week!
8:40 AM Jun 28th via HootSuite in reply to ELNC
.DISSIMILAR on the open for US stocks is likely
bit.ly/cJjdCA #ARYC #invest #stocks (REUTERS)
3:55 AM Jun 28th via HootSuite
They may have put out the PR to try to prop up the stock price which has been in kind of free fall the last couple of days because of the lack of any meaningful news about the company.
It is a nice PR though because as Silver said it mentioned the high sensitivity and specificity they are getting with OvaDx. And that it is both for early and late stage ocvarian cancer is also important.
I looked to see what impact the news had on the market after the 2:13 PM release and here are all the trades for the day. Our "friend 100 trader" got us to 0.70 at 2:38 pm. Then after hours we had a trade for 0.58.
We'll see what happens tomorrow when the PR is more widely read.
t 0.58 1000 OBB 16:01:09
0.70 100 OBB 14:38:45
0.55 1000 OBB 14:03:10
0.694 100 OBB 13:11:33
0.551 1150 OBB 10:00:40
0.55 350 OBB 09:41:20
I agree with you, the prices today were all over the map, very volatile. Don't know the significance of this. And like you said, the close was awful, the lowest price in quite some time.
0.51 392 OBB 15:32:35
0.51 1000 OBB 15:25:05
0.74 100 OBB 12:08:08
0.549 2500 OBB 11:25:52
0.549 1000 OBB 11:08:59
0.549 500 OBB 10:45:30
0.549 1200 OBB 10:45:09
0.549 100 OBB 10:45:09
0.549 450 OBB 10:45:09
0.55 5000 OBB 10:45:07
0.55 500 OBB 10:44:59
0.55 4000 OBB 10:44:59
0.55 500 OBB 10:44:59
0.55 500 OBB 10:37:35
0.59 1300 OBB 10:26:24
0.63 2900 OBB 09:45:31
We have to be a little skeptical about their dates forecast, after all in Dec.17,2009 news release John Howell said the following:
"Notwithstanding any unexpected delays with the 510(k) review and approval process, we are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010, followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010".
The dates have been moved forward a couple of times already. And that is before FDA submission, once the FDA is in the picture, who knows.
At the investors conference presentation in early June, Mark Schena said the FDA submission was scheduled for the 3rd quarter.
I think genomeweb wants to restrict much of their material to "premium subscribers" only. They charge a fee for that. They allow free info at times to entice subscribers.
The whole picture with the details of OvaDx is murky. We have to read the tea leaves to find out what's going on. They want investors to have blind faith in the company. Hopefully it'll all become clearer once they submit the 510K.
Tricky science this is, trying to find the right number and kind of markers. In the 2005 interview with Dr. Tainsky (post 949) they asked him:
What specificity and sensitivity are you seeing so far?
Current numbers are in the 93rd percentile for each. That’s on a small panel of 480 markers. We’re now working up 3,200 new markers on a chip to increase the specificity and sensitivity.
But in Dec 2009 biosensing blog (post 951) reported that
using antigen array with 65 different tumor antigens immobilized on a single chip a sensitivity of 55% and specificity of 98% was achieved.
So Specificity went up with the reduced set of markers, but sensitivity went down. What will happen with the new 100 markers set?
Interesting that Tainsky in 2005 considered 480 markers a small number.
Re: "I think its quite safe to say one of the primary reasons for all the additional biomarkers is to eliminate false positives for ovarian cancer and thus making it much more appropriate for a screening use"
I found this rare reference to the results that they were getting in the Arrayit system in Dec 2009 using 65 biomarkers. Increasing it to 100 biomarkers hopefully helped both sensitivity and specificity results and got them closer to the ideal 75% sensitivity and 99.6% specificity needed for a true screening test. We'll see when they publish the final results.
Multiple Opportunities: Multiplexed Assays for Cancer Diagnosis
December 22, 2009 · 1 Comment
"....Now comes the news that ArrayIt Diagnostics has licensed out ovarian cancer biomarkers from Wayne State and will apply for pre-market approval with FDA for its diagnostic test."
...
"The ArrayIt system on the other hand is a true multiplexed assay based on the protein array technology developed by Prof Tainsky at Wayne State University. Prof Tainsky’s technology measures autoantibodies against the multiple tumor antigen simultaneously in a single sample. Using antigen array with 65 different tumor antigens immobilized on a single chip a sensitivity of 55% and specificity of 98% was achieved.
The final format that ArrayIt will use is not clear and can be protein array format or bead array platform like Luminex. Whatever is the platform, it is clear that multiplexed assays are finding their niche in diagnostics and possible drug discovery."
http://biosensing.wordpress.com/2009/12/22/multiple-opportunities-multiplexed-assays-for-cancer-diagnosis/
Todd Martinsky made the 1 comment on 1/29/10 in response to the article:
"Not Luminex, OvaDx Ovarian Microarray will be on Arrayit’s own proprietary platform."
Thankss for posting the interview. I think his science is solid, and he's been doing this for a long time. He had hope to have a test 5 years ago. I'm sure he's happy it is going to be a reality soon. This interview is from 5 years ago. It would be nice to see an updated interview or article as to how far he has progressed since.
I read the link from 910 last night, but the link for 911 although I read it the other day, now genomeweb says is for "premium subscribers" only. In any event having Tainsky involved in OvaDX is a big plus, and according to the Dec 10 press release, Tainsky sounds very confident of where they are headed.
One thing going in ARYC's favor is its association with Dr. Tainsky from Wayne State U. I trust he will do the right clinical study. They mentioned in the press release that you posted a few days ago that their 6 month project will provide for a much a larger test population. Dr. Taiskky has been using ARYC technology for more than 6 years.
From the Dec 10, 2009 press relese
HOUSTON, Dec. 10 Arrayit Diagnostics, ... today announced that it has executed a sponsored research agreement with Wayne State University and Arrayit Corporation, which encompasses continuing research and development of a microarray-based diagnostic test for the early detection of ovarian cancer.
This newly sponsored research project will be jointly conducted at the laboratories of Wayne State University in Detroit, Michigan and Arrayit Corporation in Sunnyvale, California, and will provide for a much larger test population than previously studied in prior, related research projects. Dr. Michael Tainsky, Ph.D., director of molecular biology and genetics at Karmanos Cancer Institute and professor of pathology at Wayne State University's School of Medicine, will serve as principal investigator of the six-month project, working in close collaboration with Dr. Mark Schena, Ph.D., President and Chief Science Officer of Arrayit Corporation.
"For more than six years, Wayne State University has used Arrayit's microarray manufacturing technology to help identify key biomarkers using a novel process that has allowed us to isolate biomarkers unique to ovarian cancer," noted Dr. Tainsky. "As a result, we are now in late stage development of a simple blood test for the early detection of ovarian cancer that holds tremendous potential to materially - and perhaps profoundly - impact the survivability and quality of life of ovarian cancer victims."
Dr. Schena stated, "Through the combined efforts of Dr. Tainsky's and our research teams, Arrayit Corporation will perfect a panel of biomarkers printed in a microarray that will enable detection of ovarian cancer prior to the appearance of any symptoms. This research project is an important extension of Arrayit's ongoing relationship with Dr. Tainsky and Wayne State University, and should provide an unequivocal validation of the positive results we have achieved thus far, ultimately supporting and enhancing Arrayit Diagnostic's sales and marketing strategy."
In addition to the right sensitivity and specificity, the clinical study has to include the right population. I assume Arrayit is doing all the right things, but the data has not been made public yet.
When Labcorp tried to market Ovasure without FDA aprroval, they got this letter from the FDA. Labcorp is still in discussion with the FDA and hope to market Ovasure some day.
Portions of the letter say:
"It appears that you are marketing the OvaSure™ Test with performance characteristics (specifically, 95.3% sensitivity and 99.4% specificity) that are identical to those reported in a research study published by Visintin, I., et al., in the February 15 edition of Clinical Cancer Research (Visintin, I. et al., Clin Cancer Res. 2008 Feb 15;14(4):1065-72.). We note that this research was carried out, and performance derived, on two populations that are strongly clinically biased for being healthy and normal, and for having already experienced ovarian cancer. Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in “high risk women who might have ovarian cancer”, i.e., in a clinical setting, as claimed in your intended use and promotional materials."
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm125130.htm
Silver, that article was a great find. Interesting that with with the two-step approach they discuss the specificity of the screening test itself would only need to be 98% because combined with the TV sonogram you get to the 99.6% specificuty required.... TVS is offered only to women with positive serum assays, for which only women with suspicious findings on TVS undergo surgical evaluation.( one caveat the study population comprised only postmenopausal women)
Bart, that's a good question. I just looked at Vermillion's stock price to see what happened after they submitted the 510K for OVA1.
The price was around 2.00 before the submission on 6/25/08 and the price went up to 2.45 right after the news. This is a smaller gain than I expected to find.
Then the stock continued to go down until it reached 0.05 just before FDA approval on Sept 11,2009. The day the approval was announced the price went up to 2.00 and continued to go up until it reached a high of around 34.00 on March 12,2009 around the time OVA1 became available. The price has been declining since and is now at around 13.00 I guess the market expected bigger revenues from VRML than what they are getting right now, but it has only been one quarter since they started marketing OVA1.
There are already the pairing of Abbott/Fujirebio and Quest/Vermillion for the other ovarian tests. Arrayit so far is going it alone with OvaDx. Is that by choice or are the big Diagnostics firms not interested in an allinace yet? Somehow I don't think the current ArrayitDX under JH is capable of marketing this test alone.
JH annouce a very rosy milestones scenario in the December 17, 2009 press release. He has missed the dates so far. Are people taking him seriously?:
Howell stated, "In response to numerous inquiries received from the medical, research and investor communities following last week's exciting news announcements, we are pleased to confirm that Arrayit Diagnostics will file for Pre-Market Approval of our early stage ovarian cancer test as an 'In Vitro Diagnostic Multivariate Index Assay' shortly after the end of this year. Notwithstanding any unexpected delays with the 510(k) review and approval process, we are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010,followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010."
Continuing, Howell added, "With plans to market the test at a cost of approximately $350 per test kit - and presuming we achieve our predetermined time-to-market objectives, we are confident that revenue of $4-$5 million is an attainable sales goal for 2010. Moreover, given that we estimate the total market for a viable early stage ovarian cancer screening test in the U.S., Japan and Europe could collectively represent use of up to 175 million kits per year; beyond 2010, annual revenues for Arrayit Diagnostics could ultimately reach into the hundreds of millions, and perhaps even billions, of dollars."
There are already the pairing of Abbott/Fujirebio and Quest/Vermillion for the other ovarian tests. Arrayit so far is going it alone with OvaDx. Is that by choice or are the big Diagnostics firms not interested in an allinace yet? Somehow I don't think the current ArrayitDX under JH is capable of marketing this test alone.
JH annouce a very rosy milestones scenario in the December 17, 2009 press release. He has missed the dates so far:
Howell stated, "In response to numerous inquiries received from the medical, research and investor communities following last week's exciting news announcements, we are pleased to confirm that Arrayit Diagnostics will file for Pre-Market Approval of our early stage ovarian cancer test as an 'In Vitro Diagnostic Multivariate Index Assay' shortly after the end of this year. Notwithstanding any unexpected delays with the 510(k) review and approval process, we are optimistic that we will be in position to begin marketing the test for research purposes late in the first quarter of 2010, followed by official commercial launch to the medical diagnostics industry as early as the third quarter of 2010."
Continuing, Howell added, "With plans to market the test at a cost of approximately $350 per test kit - and presuming we achieve our predetermined time-to-market objectives, we are confident that revenue of $4-$5 million is an attainable sales goal for 2010. Moreover, given that we estimate the total market for a viable early stage ovarian cancer screening test in the U.S., Japan and Europe could collectively represent use of up to 175 million kits per year; beyond 2010, annual revenues for Arrayit Diagnostics could ultimately reach into the hundreds of millions, and perhaps even billions, of dollars."
Although QUEST is "marketing OVA1 in accordance with FDA clearance guidelines … and we expect that’s how physicians will use the test." There is the likelihood that OB-GYNs will begin using OVA1 off-label as a screening test, which would sharply increase the market for the assay.
Vermillion is also working on OVA2. There are not too many details about OVA2 but people familiar with the company's thinking say the test could turn out to be a screening version of OVA1. They are also working on OVA3 but there are even less details about that one.
Source:
http://www.genomeweb.com/blog/vermillion-likely-label-play-ova1-ova2-gains-rd-traction
From what I gather, OvaCheck is for symptomatic women. They use 8 biomarkers, and a couple of those came into question in the past. The best specificity I saw reported for OvaCheck was 95%, way to low to be a screening test.
If OvaDx holds up under scrutiny and the specificity is as good as Arrayit Corp. says it is, it should have nothing to worry about and it will beat any competition.
Remember the post:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50018632
In there "Annette Fribourg, a spokeswoman for Correlogic, said that following a double-blinded clinical trial completed in late 2008, the company filed a 510(k) application with the FDA. Correlogic has been "engaged in discussions with the agency since then regarding the appropriate regulatory pathway," she said, adding the firm is in the process of obtaining a CE mark in Europe."
That CE mark in Europe is the approval they just got.
According to this May 7, 2010 article, which makes for interesting reading, Correlogic hopes to get approval of OvaCheck by next spring.
Three biotechs find the winding road to FDA approval and market success is always longer than it appears
http://washington.bizjournals.com/washington/stories/2010/05/10/focus1.html?page=2
Not me. I'm slowly learning some of this stuff by reading any available material relevant to cancer screening tests. I did graduate from Engineeering school, and by the way my worst subject was biochemistry.
Accurate screening tests are desperetely needed. And the companies that succeeed in this effort will be rewarded handsomely.
You're welcome. As you can see we are excited about the potential of Arrayit's first screening test.
Thanks for the additional information.
One thing about the 99.6% specifity for an ideal screening test. It means that the rate of false positives is 0.4%. So for 2500 post-menopausal women the number of false positives would be
0.004 X 2500 = 10 false positives
Since the incidence of true positives is 1 for every 2500, that means that the test is finding 10 false positives for each true positive.
As a comparison:
The Vermillion OVA1 test alone is said to have achieved an overall sensitivity of 92%, specificity of 43%, positive predictive value of 42%, and negative predictive value of 93%.
Very interesting analysis, and a market mover. Just after you published it the stock price went up almost 8% to 0.70 (LOL).
OvaDx is a winner in any case, and the higher its specificity the better the reward. Arrayit has said that they are achieving excellent specificity results in their lab work. As you said, it would need to be validated and duplicated.
According to the "Biomarkers in Medicine" paper, "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."
They did not address the sensitivity figure required. Maybe the number of false negatives, as long as it is low, is not as crucial for a screening test?
Regarding Vermillion's OVA1, they used Health Discovery Corp's SVM (support vector machines)technology in conjunction with its protein based SELDI mass spectrometry technology. Don't know if Arrayit's technology is associated with SELDI.
You're right, there seems to be venture capital out there. Here is another $25. mill annouced yesterday. $25M seems to be the going figure:
Predictive Biosciences Pockets $25M Round, Launching First Bladder Cancer Tests
http://www.xconomy.com/boston/2010/06/16/predictive-biosciences-pockets-25m-round-launching-first-bladder-cancer-tests/
Thank Silver for the two archived articles from 2004 and 2005 about Tainsky's work. We are still not sure whether OvaDX will be using his work or the biomarkers developed "completely in house" at Arrayit. See our messages #840 and #842
I guess we'll find out in the 3rd quarter?
Fingernail test detects cancer
Winner of Australias's ABC-TV "The new inventors" show
A DEVICE with the potential to detect cancers and Alzheimer’s disease years before any other modern means has been discovered by a former Tweed Heads professor.
The Fibre Diffraction Diagnosis (FDD) can unveil cancers including breast, prostate and melanoma in a cost-effective, non-invasive procedure by simply studying x-rays of a person’s fingernail clippings or skin.
Adjunct Professor Veronica James showed off the life-saving discovery on ABC show The New Inventors last week.
But “invention” is not the word the 70-year-old would use to describe the FDD.
“It feels more like a serendipitous discovery to me,” Prof James said.
“It can’t cure, but it will enable the diagnosis of the disease early enough for successful treatment.
“I believe it can help everyone, even people whose cancer is temporarily gone.”
Prof James has conducted tests on more than 4500 samples, not one returning a false negative reading.
Analysis of certain patterns in fingernail clippings show breast cancer, colon cancer and Alzheimer’s disease, while skin samples can show the presence of prostate and melanoma cancers.
“The good thing about detecting Alzheimer’s before the brain is damaged is that we can stop dementia,” Prof James said.
The OAM recipient said she was currently working on ways to discover if prostate cancers detected are high- or low-range cases.
“People can live a full life with low-range prostate cancer, but high-range can kill you,” she said.
“Unnecessary surgery on low-range cancers can lead to bad side effects.
“It will be a gift to all men if we can show that it’s only low-range prostate cancer.”
In one case, the device detected an American woman’s breast cancer three years before it was picked up by a traditional mammogram.
“I was invited along for three years to test the same samples. I found that she had breast cancer in year one, but the mammogram said otherwise. I tested it annually for two more years and on the third the mammogram confirmed my findings, but she only had six months to live at that point,” Prof James said.
The device is set to go into clinical trials for prostate cancer in London.
The FDD impressed the panel of judges on The New Inventor.
Scientific broadcaster Bernie Hobbs said she could not wait to see the publications and peer reviews that prove the method worked.
The FDD won invention of the night and picked up the people’s choice award the week after.
Tweed Daily News (Australia)- - June 18th,2010