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Mark's email to the Admiral saying that things are going well at Arrayit and asking " to watch for important press releases that will detail progress" was from 7/28, more than 3 weeks ago. So far we are still waiting. But a lot of investors are not being as patient as Mark would want them to be and are voting with their feet driving the stock down and down (it's at 0.25 today)
That's hilarious! I sure hope they stop waving at the passing parade and be the grand marshall leading the way.
Novel Ovarian Cancer Test Shows Promise
In early experiments, new method displayed 100% accuracy, researchers say.
The Georgia Tech method, which appeared to register no false positive or negative results, was developed by Facundo Fernandez, an associate professor in the school of chemistry and biochemistry.
http://www.hon.ch/News/HSN/642111.html
This above study from the Georgia Institute of Technology has got a lot of press over the last couple of days. Arrayit better hurry up and publish its study!
That's so funny. We needed a good laugh!
Mercifully, there have not been tweets from ArrayitDx (John Howell) since Aug 6th. This was his last (hopefully forever) stupid message:
ArrayitDX:
Here are my #followfriday recommendations @planetrussell @KellyBothum @WanderingGaia
5:35 AM Aug 6th via HootSuite
This is all very disturbing if they are in fact giving away the store like that while the little investor has to put in real and hard earned money to buy the (so far declining) stock.
Thai National Cancer Institute Joins Mabcure's Ongoing Study in Thailand - Aug 17, 2010 10:50:00 AM
http://finance.alphatrade.com/story/2010-08-17/FILSRCCA/201008171150FILSRCCACANADAPR_0015868.html
More on the net losses:
"The Company has incurred significant net losses and negative cash from operations since it was a party to the Pediatrix legal dispute. At June 30, 2010, Arrayit had a working capital deficit of $6,938,755, a stockholders' deficit of $6,986,964, and recurring net losses. The Company currently devotes a significant amount of its resources on developing clinical protein biomarker diagnostic products and services, and it does not expect to generate substantial revenue until certain diagnostic tests are cleared by the United States Food and Drug Administration and commercialized. Management believes that current available resources will not be sufficient to fund the Company’s planned expenditures over the next 12 months. The Company’s ability to continue to meet its obligations and to achieve its business objectives is dependent upon, among other things, raising additional capital or generating sufficient revenue in excess of costs."
Thanks for the analysis. I also saw in the 10-Q something I did not know:
"Under terms of a biomarker license agreement between Wayne State University and the Company, effective December 7, 2009, the Company is obligated to pay the University royalties of five percent (5%) of net sales."
And then:
"Net loss from operations was $1,236,182 for the three months ended June 30, 2010, compared with a net loss from operations of $2,045 for the three months ended June 30, 2009. For the six months ended June 30, 2010 the company had a loss from operations of $1,787,707, compared to a loss from operations of $104,565 for the three months ended June 30, 2009."
Not sure what that means. Does this mean they are not "cash flow positive" anymore as they use to say they were?
A big part of the problem is that much of what they write is so cryptic that you have to guess the meaning of it. And then there are the promises that they'll tell you more later. To gain credibility, they need to come clean and spell out what they are doing.
They released the 10Q for June 30 this evening (on time!).
What do you think of the 10Q?
Information on pricing of the OVA1 test from genomeweb.
OVA1 received approval for Medicare coverage on March 11 and is being covered in the amount of $516.25 per test. The average reimbursement rate for the 342 tests recorded as revenue during the quarter was $571, which Page said indicated that private insurers offering higher reimbursement rates were approving OVA1, as well.
According to the company's licensing agreement with Quest, it receives a minimum of 25 percent of Quest's gross margin on sales of the test. Gardiner said that it was too early to say what future reimbursement rates would be, but did say she believed the $516.25 reimbursement rate offered by Medicare was "the floor."
In June, Vermillion received a European patent covering the use of the OVA1 biomarkers for the detection of ovarian cancer . According to Page it expects to receive a CE mark for the test by the end of 2010 and to launch commercially in Europe and beyond in 2011. The company's initial strategy involves working with Quest to market the test in England, India, and Mexico, she said. It also plans to explore expansion into other parts of Europe, Asia, and South America.
.....
"We're evaluating and validating biomarkers that may expand our ability to other diagnostic arenas in the field of ovarian cancer. Our initial plan for OVA2 includes additional biomarker discovery to enhance the overall positive predictive value and specificity achieved by OVA1," he said, noting that the company will provide an update on that program at the end of the year.
http://www.genomeweb.com/proteomics/vermillion-posts-344000-q2-revenues-including-first-sales-ova1-test?page=2
You made me laugh with that comment :D
ARYC wants to submit Parkinson's disease test for FDA approval in 2nd QTR of 2011. At the Investor's conference in early June, ARYC said that it is looking for capital to do this. ARYC test is supposed to find the disease 25 years before symptoms occur.
In the NY Times article they say that "A $40 million project to look for biomarkers for Parkinson’s, sponsored by the Michael J. Fox Foundation, plans to enroll 600 study subjects in the United States and Europe."
That would be a way to get the capital. But the problem is that if this a collaborative effort, ARYC would have to share the data and we know too well that ARYC does NOT share data.
Rare Sharing of Data Leads to Progress on Alzheimer’s.
Collaboration Between Science and Industry Seen as Model for Parkinson's Studies
By GINA KOLATA (NY Times)
Published: August 12, 2010
http://www.nytimes.com/2010/08/13/health/research/13alzheimer.html?_r=1&hp
In 2003, a group of scientists and executives from the National Institutes of Health, the Food and Drug Administration, the drug and medical-imaging industries, universities and nonprofit groups joined in a project that experts say had no precedent: a collaborative effort to find the biological markers that show the progression of Alzheimer’s disease in the human brain.
Now, the effort is bearing fruit with a wealth of recent scientific papers on the early diagnosis of Alzheimer’s using methods like PET scans and tests of spinal fluid. More than 100 studies are under way to test drugs that might slow or stop the disease.
And the collaboration is already serving as a model for similar efforts against Parkinson’s disease. A $40 million project to look for biomarkers for Parkinson’s, sponsored by the Michael J. Fox Foundation, plans to enroll 600 study subjects in the United States and Europe.
...But we all realized that we would never get biomarkers unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately.” ...
...The problem in the field was that you had many different scientists in many different universities doing their own research with their own patients and with their own methods,” said Dr. Michael W. Weiner of the San Francisco Department of Veterans Affairs, who directs ADNI. “Different people using different methods on different subjects in different places were getting different results, which is not surprising. What was needed was to get everyone together and to get a common data set.” ...
I just wish there was more scientific information out there about OvaDx so that doctors and scientists could "kick its tires"
This is from the blog
Libby's H*O*P*E*
*Helping*Ovarian Cancer Survivors*Persevere Through*Education
The Cancer Biomarker Conundrum: Too Many False Discoveries
The boom in cancer [including ovarian] biomarker investments over the past 25 years has not translated into major clinical success. The reasons for biomarker failures include problems with study design and interpretation, as well as statistical deficiencies, according to an article published online August 12 in The Journal of the National Cancer Institute....
http://healthinfoispower.wordpress.com/2010/08/12/the-cancer-biomarker-conundrum-too-many-false-discoveries/
The volume of OVA1 tests in the second quarter seems paltry. Let's hope OvaDx does better than that in its first quarter after deployment.
-----------------------------------------
Vermillion Posts $344K in Q2 Revenues
August 12, 2010
NEW YORK (GenomeWeb News) – Vermillion today reported revenues of $344,000 for the second quarter and a net loss of $698,000.
The company, which emerged from Chapter 11 reorganization in January, had posted no revenues in the year-ago period and a loss of $1.8 million.
For the three months ended June 30, Vermillion had $45,000 in product revenues from sales of its OVA1 triage ovarian cancer test, and $299,000 of license revenue from Quest Diagnostics for achieving certain milestones under the two companies' strategic alliance agreement.
On a per-share basis, the company saw a loss of $0.07 for the quarter, compared to $0.28 in the year-ago period.
Net loss for the quarter included non-cash expenses of about $371,000 in stock compensation expenses and $828,000 related to the debtor's incentive plan. Vermillion took gains of $3.5 million from the exercise and fair value revaluation of warrants, the company said.
The OVA1 test was launched in March and through the second quarter, 1,247 tests had been performed, company officials said, of which 342 were recognized as revenues. By the end of the year, the company expects between 8,000 to 10,000 tests to be performed, CEO Gail Page said during a conference call following the release of Vermillion's earnings[
In 2011, she said, Vermillion and Quest expect to launch OVA1 internationally with an initial introduction in England, India, and Mexico. The company will also evaluate the markets in Asia, Europe, and South America
During the call, Eric Fung, chief scientific officer of Vermillion, said that the company is currently working with collaborators at Johns Hopkins University to develop OVA2.
"We are evaluating and validating biomarkers that may expand our ability to enter into other diagnostic arenas in the field of ovarian cancer," he said. "Tests that have a wider field of view, such as evaluation of symptomatic women or high-risk women, will require greater clinical specificity."
The other test in Vermillion's pipeline is for peripheral arterial disease, which is being developed with Stanford University. By the end of the year, Vermillion plans to start an intended-use population study, Fung said.
Vermillion spent $938,000 on R&D in the quarter, up from $595,000 a year ago. SG&A costs rose to $3.1 million from $448,000 in Q2 2009.
As of June 30, the company which recently moved its headquarters to Austin, Texas, had about $29 million in cash, cash equivalents, and short-term investments.
During the quarter, Vermillion also hired 11 sales people, bringing the total number of employees to 23 as of today. Last month the company was relisted on the Nasdaq.
In early morning trade today, the company's stock was down about 21 percent at $7.16.
It could simply mean that Sigma Aldrich buys Peptide microarrays from Arrayit. If so, why are they calling "Arrayit and Sigma-Aldrich team up" to a simple vendor-purchaser relationship?
One would think that after a tweet like that they would follow up with a press release, but so far nothing.
Cancerwatch Publishes Article on PV-10 for Melanoma
An article on PV-10 for metastatic melanoma was published in the July 2010 edition of Cancerwatch. The article, titled "Robust Response in Metastatic Melanoma to Rose Bengal (PV-10)", highlights the very positive results of the Phase II trial of PV-10 for metastatic melanoma.
August 9, 2010
http://www.pvct.com/news/cancerwatch-07-2010.pdf
HUMan MOLecular GENetics blog has a directoy of Biomedical companies. Here is Arrayit's self description in the registry.
http://hum-molgen.org/companies/profile.php3/984-arrayit-corporation
registry of biomedical companies
Arrayit Corporation
Arrayit Corporation offers the market's most advanced microarray platform for genomics, proteomics, diagnostics and agricultural research. We lead and empower the genetic, research, pharmaceutical and diagnostic communities through the discovery, development and manufacture of proprietary life science technologies and consummables for disease prevention, treatment and cure. Our diagnostics pipeline contains pre-symptomatic tests for ovarian cancer (OvaDx®), Parkinson's Disease and prostate cancer, as well as a companion diagnostic for Plavix®. Arrayit offers the world's finest biomarker discovery platform for the pharmaceutical industry to benchmark the efficacy and safety of blockbuster drugs. The Arrayit platform is currently installed in 3,800 laboratories worldwide, making Arrayit a leader in the microarray industry
Or to view it another way, OvaDx would be THE CAKE (potential revenue of up to $5 Billion). And the other equipment sales is the icing :D
Don't know what this nanotech website is about. If you click the about link it does not tell you anything. I just came across it via a google news alert for arrayit because they posted this video in that website today.
While we wait for news from ARYC, we can watch this arrayit-documentary that was posted on Youtube a couple of years ago. It is pretty neat. It is one of about 15 videos about Arrayit that are available (see botton portion of the screen after the video stops playing to select any of the 15)
http://nanotechfabrication.com/arrayit-documentary/
The only thing we have heard is that ARYC plans to release the data for OvaDx AFTER they submit the 510K application to the FDA sometime in the 3rd QTR. And that ARYC still hopes to get fast track approval in the 4th QTR. We'll see.
I agree totally. You hit it right on the mark.
Talking about hope, I was reading in the August 2010 issue of Money magazine the article "Navigating a highwire stock market". In there it mentions that fledgling biotech companies trade more on hope than on fundamentals, because they have little income since their drugs or medical devices have not been approved yet. I'm wondering for Arrayit since so little is currently known about their OvaDx test how much of it is hope and how much fundamentals, 50-50?
The lack of delivery of past promised PRs made me take with a grain of salt Mark's advise to the Admiral (post 1039) to watch for future PRs:
"...things are going very well at Arrayit and we encourage you to watch for important press releases that will detail progress in fundraising, FDA submissions, product development and sales, strategic hiring and partnerships, and other company matters. Management is fully committed to increasing shareholder value over time and our upcoming announcements will reflect this commitment".
More good news....
MabCure, Inc. Files Provisional Patent in the U.S. for Ovarian Cancer Antibodies
9:00 AM ET 08/03/2010 NEW YORK--(BUSINESS WIRE)-- Biotechnology company MabCure, Inc. (MBCI today announced the company has filed a provisional patent application for its ovarian cancer diagnostic antibodies with the U.S. Patent and Trademark Office. The filing was based on positive results of a recent study that showed MabCure’s tumor-specific monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent) and distinguished it from benign tumors of the ovaries or healthy blood obtained from men and women. The patent application covers a panel of MAbs, each of which is capable of diagnosing ovarian cancer, and several that can correctly distinguish between ovarian cancer and benign tumors.
“Filing the patent on these important discoveries is a significant step towards securing our intellectual property position and moving forward with potential strategic relationships and commercialization of what would be a highly specific serum diagnostic test for ovarian cancer,” said Amnon Gonenne, Ph.D., CEO of MabCure (MBCI
In a 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. The samples were comprised of 17 patients with ovarian cancer, 5 patients with benign tumors of the ovaries, 24 healthy young females and 8 males.
“Beyond the value of our test to diagnose ovarian cancer in a highly accurate manner and with no false positives, the potential value of our proprietary MAbs is also in helping to identify tumor-specific antigens or cancer-specific targets for the ultimate treatment of ovarian cancer,” said Gonenne.
MBCI MABCURE INC
0.70
Change +0.07 (+11.11%)
AS OF 11:00 AM ET 08/03/10.
The race is on between ARYC and MBCI for the Ovarian diagnostic test. MBCI pps went from 0.22 to 0.85 (now is at 0.63) after MBCI announced good results from their test last week.
Provisional Patent in the U.S. for Ovarian Cancer Antibodies filed by Mabcure (MBCI)
8/3/10 (via COMTEX News Network)
Biotechnology company MabCure, Inc. (MBCI - OTCBB),today announced the company has filed a provisional patent application for its ovarian cancer diagnostic antibodies with the U.S. Patent and Trademark Office. The filing was based on positive results of a recent study that showed MabCure's tumor-specific monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent) and distinguished it from benign tumors of the ovaries or healthy blood obtained from men and women. The patent application covers a panel of MAbs, each of which is capable of diagnosing ovarian cancer, and several that can correctly distinguish between ovarian cancer and benign tumors.
"Filing the patent on these important discoveries is a significant step towards securing our intellectual property position and moving forward with potential strategic relationships and commercialization of what would be a highly specific serum diagnostic test for ovarian cancer," said Amnon Gonenne, Ph.D., CEO of MabCure.
In a 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. The samples were comprised of 17 patients with ovarian cancer, 5 patients with benign tumors of the ovaries, 24 healthy young females and 8 males.
"Beyond the value of our test to diagnose ovarian cancer in a highly accurate manner and with no false positives, the potential value of our proprietary MAbs is also in helping to identify tumor-specific antigens or cancer-specific targets for the ultimate treatment of ovarian cancer," said Gonenne.
Other companies can report preliminary results of their clinical trials without compromising their proprietary technology. It is frustrating that ARYC refuses to release any data until after the 510K is submitted to the FDA.
Yes, wonderful news. I just read the press release. The share price has doubled today from yesterday's price.
MabCure, Inc. Announces Positive Results for New Ovarian Cancer Diagnostic Blood Test
http://news.morningstar.com/newsnet/ViewNews.aspx?article=/BW/20100727006046_univ.xml
Excerpts from the news release:
"Biotechnology company MabCure, Inc. (OTCBB: MBCI) today announced that a confirmatory study demonstrated the company’s proprietary monoclonal antibodies (MAbs) successfully identified ovarian cancer in blood (94 percent accuracy) and with no false positives or cross-reactions with benign ovarian tumors or healthy blood. MabCure’s serum diagnostic test is the first to recognize unique tumor markers or cancer fingerprints present only in ovarian cancer, the deadliest of all gynecological cancers."...
..."MabCure conducted a blinded study of several of its ovarian cancer MAbs against 54 different blood samples in collaboration with the Department of Gynecological Oncology at UZ Hospital in Leuven, Belgium. The samples were comprised of 17 patients with ovarian cancer, 5 patients with benign tumors of the ovaries, 24 healthy young females and 8 males. Results showed that each of MabCure’s MAbs correctly diagnosed 16 of the 17 ovarian cancers, with a diagnostic sensitivity of 94 percent and 100 percent correct diagnosis of benign tumors."...
..."MabCure will soon commence a follow-on study in collaboration with one of the foremost experts in women’s cancers, Ignace Vergote, M.D., Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, Belgium. The study will access a large number of previously collected clinical blood samples stored at the Bio-bank of the Catholic University Hospital, Leuven. Following the conclusion of this study, MabCure plans to launch a multi-center prospective trial in Europe and in the U.S., as well as initiate commercialization of its diagnostic ovarian cancer MAbs in Europe through strategic partnerships and licensing. In parallel, MabCure plans to embark on the regulatory process for obtaining marketing approval in the U.S"...
No, I did not ask a real question. Just said that some people were getting their emails bounced back.
The test email I sent to investorrelations@arrayit.com did not bounce back. Whatever issues they had must have been resolved.
Bill, I sent a test email myself to investorrelations@arrayit.com to see if it goes through. So far it has not been returned. I'll let you know if it bounces back.
I agree.
To avoid a similar situation, I still hope that ARYC is doing its clinical trials on the right population.
Also I wonder what will become of OVA1 and OvaCheck if OvaDx gets approved as a screening and monitoring test.
Try the top brass:
John Howell ... john@arrayit.com
Rene Schena ... rene@arrayit.com
Mark Schena ... mark@arrayit.com