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How many cancer diagnostic blood tests can the market support?
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Blood Test Could Provide Early Detection Of Cancer
Posted on: Tuesday, 1 June 2010, 08:53 CDT
The University of Nottingham spin-out company, Oncimmune Ltd, has developed a ground breaking blood test which will aid the detection of cancer as much as five years earlier than current testing methods such as mammography and CT scans. Physicians will know the result of their patient’s test within one week of sending in a blood sample to Oncimmune.
Oncimmune has developed a new technique which replicates the cancer proteins that trigger the body’s response to the disease and robotic technology to measure this response. This new technology (immuno-biomarkers) provides a significant advance in how early a cancer may be detected and is likely to change the current paradigm of diagnosis and treatment for most solid cancers such as lung, breast, ovarian, colon and prostate.
Based on the early work of John Robertson, a world renowned breast cancer specialist and Professor of Surgery in The University of Nottingham’s Faculty of Medicine and Health Sciences, Oncimmune has successfully transferred this science into a reproducible commercial test. The test for lung cancer, EarlyCDT-Lung™ will be launched nationally in the USA this month followed by a launch in the UK early next year.
Geoffrey Hamilton-Fairley, Executive Chairman of Oncimmune, said: “We believe this test, along with the others we will launch in the next few years, will lead to a better prognosis for a significant number of cancer sufferers.”
Initial research results were derived using blood samples from patients with breast cancer and a group of high risk women attending for annual mammography — which Professor Robertson had prospectively collected in Nottingham. All samples were obtained with fully informed consent as part of a study which had received approval from the appropriate ethics committee. In addition to identifying the signal in the blood of a percentage of women when they developed breast cancer the results also showed that the signal could be detected in some of the high-risk patients who had given blood samples for a number of years during their annual checkup and before they were subsequently diagnosed with cancer. When these samples were run retrospectively by Professor Robertson he showed that the prototype assay test could have detected over half of these cancers up to four years before they were actually diagnosed. The work on lung cancer followed through a European Union grant which involved both The University of Nottingham and Oncimmune in a collaboration with a number of European partners.
Professor John Robertson said “I am very pleased that the initial exciting research data that we produced in the laboratories at The University of Nottingham a number of years ago have been translated by Oncimmune to the first of many tests that will help us identify cancer early. The support of the University at all levels, including past and present Vice-Chancellors, Deans of the Faculty of Medicine and Heads of School along with the University’s Management Board has been essential. Some of the initial research work was supported by charitable funds and donations from patient groups. In the commercialization of the technology there have been a number of individuals who have continued to believe in and financially support the goal of developing a blood test for the early detection of cancer without whom this technology would not have reached this milestone. It has been a long and at times very hard road in creating a robust commercial test and those involved have worked with exceptional diligence and tenacity and have given their unremitting support to achieve this.”
A study involving researchers at the Mayo Clinic in the USA recorded similar results using blood samples from a study of CT scans to screen for lung cancer where antibodies were detected up to five years before the lung cancers were diagnosed. A number of other academic centers have reported similar results.
Oncimmune LTD was founded in 2003 to commercialize the technology developed in the laboratories of Professor Robertson. In 2006 the company set up a North American operation to validate and scale-up the test — trialing it on more than eight million assay “wells” from 80,000 patient samples.
The first early cancer detection test (EarlyCDT™) to launch will be the test for lung cancer (EarlyCDT-Lung) which has the potential to detect the early stages of lung cancer possibly up to five years before a tumor appears. The target population for this test are high-risk individuals such as long-term smokers and ex-smokers between the ages of 40 and 75. Additionally the test would be appropriate for people who have been exposed to other risk factors associated with the disease, for instance, environmental exposures such as radon, asbestos and extensive exposure to secondary smoke.
Under the guidance of Professor Robertson, The University of Nottingham has become a world leader in the field of autoimmunity in cancer. Using the technology developed by Oncimmune there is, for the first time, a reliable platform available for testing the autoimmune response to cancer and further research will allow validation of the test in other tumor areas such as lung, colon and ovarian cancer.
To support this, the University is to establish a Centre of Excellence for Autoimmunity in Cancer (CEAC) with Professor Robertson as the Director of Research. The new center will foster collaborative research to: speed up the delivery of an autoantibody blood test for different types of cancer for clinical use; encourage other research in the area of autoimmunity in cancer; and continue the search for support technologies that have the potential to enhance the medical prognosis following a positive test result.
Professor David Greenaway, Vice-Chancellor of The University of Nottingham said: “The establishment of CEAC will provide state-of-the-art technologies to continue world leading research and development in the early detection of cancer using autoantibodies. The new center will house a multi disciplinary research team working in partnership with international collaborators and Oncimmune. The research will provide additional test systems for the early diagnosis of a wide range of cancers which will have considerable impact within clinical medicine. The group’s discovery science which has led to a novel set of biomarkers is providing new insights into the biology of cancer. Their basic, translational and clinical research is likely to contribute to a positive paradigm shift in our understanding of the early phases of cancer cell development as well as enhancement of the medical management of a wide range of cancer types.”
Initially the test will be offered via primary care physicians and pulmonologists in the USA for high risk asymptomatic patients as well as patients who have indeterminate lung nodules. Oncimmune will bill private insurance companies as well as government-run Medicare Part B carriers on behalf of the patient.
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On the Net:
University of Nottingham
More information can be found at http://www.oncimmune.co.uk or http://www.oncimmune.com/
Example of a PR from Mabcure Inc., one of Arrayit's competitors. It is a memorandum to shareholders from MBCI's CEO informing us of the progress MBCI is doing in their product development of ovarian cancer, melanoma and prostate cancer diagnostics.
http://www.4-traders.com/MABCURE-INC-846352/news/MABCURE-INC-Memorandum-to-Shareholders-From-Dr-Amnon-Gonenne-MabCure-s-Chief-Executive-Officer-13386985/
Memorandum to Shareholders From Dr. Amnon Gonenne, MabCure's Chief Executive Officer
06/01/2010 | 08:10 am
MabCure, Inc. (OTCBB:MBCI):
Dear Shareholders:
I am pleased to update you on the progress of our research and development.
Over the past several months we have been working intensively on advancing our various programs with an emphasis on melanoma and ovarian cancer diagnostics. We consider these two projects near-term in their respective development stages, as I describe below.
In January 2010, we announced the commencement of our clinical trials at the Ramathibodi Hospital in Bangkok, Thailand to evaluate the potential of our panel of monoclonal antibodies (MAbs) to diagnose ovarian cancer in high risk patients. Since the study began, patients have been recruited at a solid pace and in line with our schedule. In addition, we are privileged that the Thai National Cancer Institute has decided to join our study and is currently reviewing our study protocol. The study is estimated to be completed within 5-6 months, as originally planned.
In parallel to our study in Thailand, we are planning to commence a study in collaboration with a major medical center in Belgium of several hundred blood samples which were obtained from patients over the past several years. The purpose of this ?retrospective? study is to provide additional proof of the ability of our MAbs to correctly diagnose ovarian cancer, and is of considerable importance given the significant number of blood samples to be tested.
The study will be ?blind? to all involved (i.e. the samples will be coded and neither the clinicians nor MabCure scientists will know the identity of the specimens until the study is complete), so as to prevent any bias in the analysis of the results. The study is expected to last several weeks and will commence once a formal agreement has been signed with the Belgian medical center. As a prelude to this study, we conducted a pilot study on a limited number of these ?retrospective? specimens to calibrate the optimal technical conditions for our MAbs.
In parallel, we are conducting an independent study in Germany aimed at testing the ability of our antibodies to bind to different ovarian cancer tissue specimens. The purpose of the study is to select those antibodies which are most suitable for use as imaging agents and therapeutic agents. Results from this study are expected within 2 months.
We have also made progress with our anti-melanoma MAbs. Melanoma is the most lethal form of skin cancer, accounting for 75% of deaths from skin cancers. The survival rate for advanced melanoma is as low as 15 percent, but if detected early (before the tumor penetrates the epidermis) the survival rate can reach 99%. According to the National Cancer Institute (NCI), 1 in every 53 people in the U.S. will be diagnosed with melanoma of the skin during their lifetime.
In addition, between to 2 to 8 percent of the Caucasian population in the U.S. and Europe are at a significant increased risk for developing melanoma from the appearance of atypical moles (known as dysplastic nevi or DN) on their skins. This translates to approximately 4M-16M people in the U.S. and 10M-40M people in Europe. Consequently, there is a significant unmet need to identify those moles which have been transformed into melanoma.
We recently initiated an independent third-party study in the U.K. of our antibodies for diagnosing melanoma in tissue specimens. The purpose of the study is to obtain rigorous proof of the specificity of our MAbs, using standards required by the U.S. FDA.
We plan to initiate a follow-up clinical study of our anti-melanoma MAbs by a highly esteemed European group which specializes in melanoma. The purpose of this study is to prepare the groundwork for entering the European market with a diagnostic MAb for Melanoma. Negotiations for this study are currently underway and we will issue a separate press release once the study commences.
It is important to note that the results of the various melanoma studies described above will enhance our patent application position as well as will advance the application of these MAbs as imaging agents and diagnostic agents for melanoma.
In our R&D pipeline, we have a planned pilot clinical study at the Ramathibodi Hospital in Bangkok, Thailand for the diagnosis of prostate cancer in the urine and blood of high risk patients. The study protocol will be submitted shortly to the hospital's Ethics Committee for approval. The study is scheduled to begin in August and is expected to be completed by the end of the year.
I would like to reassure our shareholders that we are working assiduously to reach our milestones and to obtain clinical breakthroughs, which will benefit cancer patients as well as our investors. I would like to take this opportunity to thank all of our shareholders for their continued support and belief in our company.
Yours sincerely,
Dr. Amnon Gonenne
President & CEO
MabCure, Inc.
About MabCure, Inc.
MabCure is a biotechnology company whose vision is to change the perception of cancer as being a largely incurable disease. MabCure owns proprietary technology for the creation of unique and highly specific monoclonal antibodies (MAbs), which we plan to develop as diagnostic tools, imaging agents, and drugs to treat lethal cancers. MabCure's initial goal is to develop its novel MAbs as diagnostic tools for the detection of Ovarian and Melanoma cancers at an early stage, when these diseases are still localized and highly curable. For further information visit the Company's website at www.mabcure.com.
This news release contains ?forward-looking statements?. Statements in this news release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the change of business focus of the management of the Company and the inability of the Company to pursue its current objectives. These forward-looking statements are made as of the date of this news release and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements.
MabCure
Dr. Amnon Gonenne
President and CEO
amnon.gonenne@mabcure.com
or
Investor Relations
Jim Fallon, 212-732-4300
jfallon@ceocast.com
Thanks Bart. And you too have a nice weekend.
I did notice that ARYC stock went up 15% today. That is a good omen.
ehwest, I don't know much about HDVY other that they are working with Quest to commercialize HDC’s in vitro diagnostic tissue-based prostate cancer test as well as HDC’s urine-based prostate cancer test. Don't know where they stand on the issue of FDA approvals for these tests.
It seems that there are quite a few biotech companies in pursuit of the same goals of cancer diagnostics. Eventually there will have to be some consolidation in this industry.
Bart, you're correct the 212,000 number refers to worldwide cases per year. U.S number is 21,550 per year.
From the National Cancer institue web page:
Estimated new cases and deaths from ovarian cancer in the United States in 2009:
New cases: 21,550
Deaths: 14,600
From Cancer Research UK web page:
Worldwide there are more than 204,000 new cases of ovarian cancer each year. Around 43,000 cases occur each year in Europe and 22,000 in the USA
And I agree that OvaDx should be more accurate and save money in the long run.
And the fact that Mark "Schena helped the FDA develop its protocols for microarrays as in vitro diagnostic multivariate index assays, and was part of the agency's Microarray Quality Control project" should help OvaDx get FDA approved
This September 22,2009 article on genomewe.com refers to
IVDMIA — a category that remains in a murky purgatory
http://www.genomeweb.com/blog/labcorp-hints-its-ovasure-assay-remains-play-quest-readies-ovacheck-launch
It also says
"As for FDA’s current IVDMIA stance, the agency may have to go back to "square one," according to Alberto Gutierrez, the newly appointed director of FDA's Office of In Vitro Diagnostic Device Evaluation and Safety.
Speaking during a health-care conference last month, Gutierrez said "[t]here is a lot of uncertainty [over IVDMIAs] because healthcare has runaway costs and this administration [of President Barack Obama] wants to do something about it.”
I think that they would have to present more details to the potential investors at the conference on 6/5 in order to get their money.
ehwest, refer to post # 680, an article from clinica.com.uk dated Jan 15,2010
In it is the only data publicly available:
"In studies that have been carried out to date, in up to 1,000 patients, there have been no false-positive results, he said. "There have been several false negatives, but we expect this to be very low once we've refined the test." Although this means there is a slight risk of missing cases of cancer, Dr Schena pointed out that this was better than the current alternative – nothing.
"Arrayit is also working on tests for the early diagnosis of other diseases such as Parkinson's and prostate cancer."
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Also they have said that as result of the specificity they are achieving in their lab work and because their approach is novel to the health care industry, they are committed to communicating proven results rather than discussing speculations. The details of this screening and monitoring test for pre-symptomatic ovarian cancer will be announced after completion of independent trials.
Application for FDA approval is supposed to occur in late 2nd QTR or early 3rd QTR 2010. So, I guess the independent trials must complete before then, at which time they will present the data.
It's a puzzle why they don't mention OvaDx at all in this article. Ovadx and Arrayit surely fly under the radar!!! It says here that Labcorp is Vermillion's chief rival. Labcorp tried to launch Ovasure in the past without FDA approval and got in hot water with the FDA. Labcorp has been in discussions with the FDA since then.
For Vermillion, a Likely Off-Label Play for OVA1 as OVA2 Gains R&D Traction
(from genomeweb.com)
By Kirell Lakhman
May 26, 2010
Vermillion released its first-quarter earnings report yesterday, and it came as no surprise that it remains in financial hot water.
And the steps it takes over the next several quarters will directly affect its partner Quest's position in the ovarian cancer triage-test market — not least because its chief rival, LabCorp, has repeatedly said it remains committed to re-launching its answer to OVA1, the OvaSure.
But it does have a handful of potentially lucrative tricks up its sleeve — one of which, admittedly, it has no control over. These include the likelihood that OB-GYNs will begin using OVA1 off-label as a screening test, which would sharply increase the market for the assay; launching a sister assay, OVA2, which is currently in development; and debuting a blood test to detect peripheral artery disease.
There has also been some talk about an OVA3 test, but details about it are more scarce than for OVA2. What is known is that OVA3 was mentioned as recently as March in a breakout session during a financial conference, according to two people who were present.
Vermillion and Quest, which will presumably market and perform these tests at its Chantilly Nichols Institute in Chantilly, Va., have also redoubled their efforts to win over additional payors to cover OVA1, and Vermillion has begun to consider selling the test in Japan, where the incidence of ovarian cancer has grown at twice the rate as in the US, according to people familiar with the companies' plans.
But first Vermillion must make its way out of the woods.
A quick recap: The company emerged from bankruptcy in January, four months after its sole bread winner, the OVA1 triage test, won FDA clearance. The test costs $650 and is reimbursed at $540 by Medicare, Vermillion has said. A company spokeswoman also told me Vermillion has "a contract with a private health plan," but would not name it.
Since launching the test in March and securing Medicare coverage for it "exceptionally quickly," in the words of one industry analyst, the company has sold only $73,000 worth of the test in the first quarter of 2010 — a far cry from the $9.7 million is expects to generate in sales of the test for the entire year.
More troubling, Vermillion has amassed more than $290 million in debt since it went public a decade ago as a mass-spec vendor called Ciphergen Biosystems. And tools at its disposal for nibbling away at that debt include either raising cash — an option Vermillion has said it currently evaluating — and selling more OVA1s and developing and marketing additional assays.
"To become profitable, [Vermillion] may need to complete development of additional key diagnostic tests, obtain FDA approval, and successfully commercialize those products in addition to the OVA1 test," the company warned in an SEC filing last week.
One such test is its peripheral-artery disease assay, VASCLIR, which Vermillion has been co-developing with a team from Stanford University. In the SEC filing, Vermillion said "to date, Quest has selected only two diagnostic tests, which are … VASCLIR and the OVA1 test, to commercialize."
Vermillion has not said when it will be ready to submit VASCLIR for FDA approval.
But Vermillion has also been quietly working on another ovarian cancer test, called OVA2. The company spokesperson last month told me that "OVA2 and PAD are in our development pipeline," and said "details [will] come at a future time."
Vermillion has disclosed virtually nothing about OVA2, but people familiar with the company's thinking say the test could turn out to be a screening version of OVA1.
This strategy could simply formalize what may soon evolve organically. In interviews with OB-GYNs, I learned that some would order OVA1 for certain patients and would consider using it off-label to screen others, but would like to see additional studies that support their belief that the test can be used in this way.
The two other steps Vermillion appears to be taking to eat away at its debt include nabbing additional payors and investigating other geographic markets for OVA1.
On the payor side, a person familiar with the company's strategy told me that as part of Vermillion and Quest's effort to secure more payors, they have divided the health-insurance market into big players and smaller players. Quest, with its vast reimbursement experience, is tackling the top-25 companies, while Vermillion chases the smaller fry.
In terms of peddling OVA1 to newer markets, Vermillion is apparently considering selling it in Japan, where the incidence of ovarian cancer in recent years has grown 10 percent. By comparison, the incidence in the US has increased 5 percent.
A person familiar with Vermillion and Quest's marketing strategy for Japan told me there could be "at least six" companies lining up to distribute the assay, which would be shipped to Quest to run.
Another potential OVA1 market is the UK, where Quest currently has a presence
ehwest, continuing with the example you give about prostate cancer, one of the problems is first correctly identifying that indeed a man has prostate cancer. The PSA test currently being used for screening gives a lot of false positives and false negatives. If a man has elevated PSA test the doctor will recommend a biopsy which is done on the prostate area most likely to be cancerous, but the cancer may be in another area not being biopsed. So there you have it a very inefficient, possibly inaccurate, expensive and anxiety producing precess to determine if you have prostate cancer or not. A blood test similar to OvaDX for prostate cancer would tell you with a great degree of certainty if you have prostate cancer or not. Then the second step for treatment as you describe is to ascertain, using tools such as the Gleason scale, how aggressive the cancer is.
A similar situation occurs with ovarian cancer. There is no test now to accurately diagnose ovarian cancer. The CA-125 now being used is 50% accurate. So 50% of the women will go thorugh the unnecessary, anxiety producing process of extra testing and dangerous surgical procedures.
OvaDx in addition to screening will be also used for monitoring the cancer during treatment and remission.
Admiral, I don't know the answer to that question. But as you say, Arrayit does need some professional guidance in the Public Relations Dept. especially as they enter the "major leagues" when they announce the OvaDx trials data and FDA application. They need to make the biggest splash possible.
From what I have learned, the details of OvaDx test will be announced after completion of the independent trials. They say Arrayit is committed to communicating proven results rather than discussing speculations. So we'll just have to wait until the trials are completed. I just hope that they do better PR when they announce the results.
Thanks for posting this Jan 7th, 2010 Arrayit news release. I had read it but had forgotten about it. As you point out, it is a very good press release. It should have made a big splash in the media but it only caused a ripple. Just like the previous news relesase which Arrayit says "that press information distributed by Arrayit on December 9th, somehow fell through the cracks."
I did a google search on the Arrayit Jan 7th PR title and got 2 hits: encyclopedia.com and bloombergnews.com.
I did a similar google search on the title of the PR of the CA-125 new approach to old test study released Thursday and got hundreds of hits in all the major media outlets and many minor ones.
Why this difference in coverage if Ovadx is a much better product which would be available this year or next and the study approach is more of the same CA-125 tests to be available in 2015 at the earliest.
Some possibilites come to mind:
1) the Arrayit release says "Researchers at a major cancer research institute have worked for six years to identify more than 100 biomarkers unique to ovarian cancer." The center's name is not mentioned and Arrayit itself is a very little known company. The study PR mentions the name of the doctors (including the doctor who invented the CA-125 test)and the hospital doing the research. Which story would you trust more?
2) AP and Reuters picked up and distributed the study story to all media outlets: TV, radio, magazines, newspapers, blogs, etc. which published and discussed the story, The story quoted medical specialists praising the test, stories of women participating in the study, some clinical data and description of what's up ahead with the clinical studies. Arrayit PR's did not do any of the above.
3) CA-125 test already has sales of over $2 billion a year and the maker of the test , Fujirebio Diagnostics, would benefit from the success of the study (more tests, more money). They have plenty of money for top-notch PR machinery. As to Arrayit they have little money and their PR dept. so far is not too effective.
Let's hope that Arrayit steps up to the PR plate when it announces the details of OvaDx screening and monitoring test after completion of their independent trials and the FDA application. The PR can not afford to fall through the cracks again.
Yes Bart, you're right. It just did not sit right that this study is getting all this extensive coverage by the media when OvaDx is so far superior. Fujirebio Diagnostics Inc, which is behind this study effort, really know how to do PR. Wish that Arrayit Diagnostics was this good at PR.
The one thing that more awareness of OvaDx could do is bring is investors to Arrayit.
I agree with you Bart. The only big problem is that the world at large seems unaware of OvaDx to reach the same conclusion that Ovadx is a far superior test. Arrayit needs to get the word out in a similar fashion outlining the results of their clinical studies and have the medical community compare and contrast the products. If Arrayit can do this before the Cancer conference on June 6, when these doctors make their presentation, OvaDx should be brought up for discussion for doctors to learn about it.
Yes this study is getting fantastic coverage and the test wouldn't be available for general use until 2015 at the earliest. Whoever is in charge of this PR surely knows how to play the media. When Arrayit announced that it was going to submit application to the FDA etc it did not get this kind of coverage in the main stream media (MSM) only the bio and medical media. As you say Arrayit has to put something out to INTRODUCE Ovadx to the MSM and compare and contrat OvaDx to this study.
You're right on both counts. Also, this study in the U.S. was for around 3000 women. In the U.K. they are trying the method in over 200,000 women. As you say we need Arrayit to describe their studies in detail, pronto. It would be a great topic of discussion at the Cancer Conference in Chicago.
This News release about a new promising study is being picked up by just about every media outlet. Talk about good PR.
And how come Arrayit is not presenting at the annual meeting of the American Society of Clinical Oncology, which begins June 4 in Chicago. More than 30,000 cancer doctors and researchers are expected to attend, according to conference organizers.
New approach to old test may detect ovarian cancer
Thu May 20, 2010 6:55pm
(Reuters) - Researchers have found a new way to use an existing blood test that may provide a way to screen women for ovarian cancer, perhaps in time to cure more women of the deadly disease.
They said combining a test that measures levels of a certain protein along with a way of measuring risk of the disease helped spot early stage cancers in otherwise healthy women.
If detected early, ovarian cancer can be cured, but more than 70 percent of women have advanced disease by the time they are diagnosed, said Dr. Karen Lu, of the University of Texas M.D. Anderson Cancer Center, who led the study.
The ovarian cancer study was highlighted among 4,500 research project summaries released today ahead of the annual meeting of the American Society of Clinical Oncology, which begins June 4 in Chicago. More than 30,000 cancer doctors and researchers are expected to attend, according to conference organizers.
"This may be pointing the way toward developing a 'mammogram' if you will for ovary cancer," ASCO president Dr. Douglas Blayney, of the University of Michigan Medical School, said in a telephone interview.
The research, released today, may lead to an annual test recommended for all women over age 50.
Ovarian cancer kills 15,000 U.S. women each year.
"Clearly there is a need for coming up with an effective strategy to detect ovarian cancer early," Lu said in a telephone interview.
She and colleagues studied a new way to use the cancer antigen or CA-125 test, which measures levels of a protein that is elevated in ovarian cancer cells.
The CA-125 test can detect rising levels of this protein, and is typically used to see if ovarian cancer has come back. But it is less sensitive in early stage cancers because levels of CA-125 can also rise from non-cancerous conditions, especially in pre-menopausal women.
Lu's team used the CA-125 test in combination with the Risk of Ovarian Malignancy Algorithm, a mathematical formula that calculates a woman's risk of having ovarian cancer based on age, CA-125 level and CA-125 levels over time.
The team studied women over age 50 who had no significant family history of breast or ovarian cancer, and put them into three groups.
Those at low risk got annual blood tests. Women deemed at intermediate risk were called back for a repeat test in three months. If the risk appeared high, they were referred for a transvaginal ultrasound, which uses soundwaves to create a picture of the pelvis.
The team found three invasive cancers in 3,238 women who participated in the study -- all early stage and potentially curable.
"What's looking promising is the trend over time," Lu said. "You could have a very low value and all of a sudden it goes very high. That is a trigger," she said.
Lu said the findings are not enough to change practice. But researchers in Britain are evaluating the blood test and risk algorithm combination in a study of more than 200,000 women. Results of that study are due in 2015.
"We'll have the definitive answer in a short amount of time," she said.
Ovarian cancer screening method shows promise in study; bigger one will see if it saves lives
Federal grants and several foundations paid for the study. Lu's colleague, Dr. Robert Bast, helped invent the $150 blood test used in the study and gets royalties from its maker, Fujirebio Diagnostics Inc.
By MARILYNN MARCHIONE , Associated Press
Last update: May 20, 2010 - 5:27 PM
Researchers may finally be closing in on a way to screen healthy women for ovarian cancer — a disease that rarely shows symptoms until it's too late to cure.
A simple blood test followed by ultrasound exams as needed found deadly tumors before they caused symptoms, and without giving too many false alarms, doctors reported Thursday.
The study, in more than 3,000 American women, is not big enough to justify screening with this method now. But doctors are encouraged because it confirms early results from a much larger study under way in England that will give a clear answer in a few years.
More important, the U.S. study suggests that this approach can find aggressive tumors — the ones that threaten lives — without putting many healthy women through unnecessary follow-up tests. Very few women needed exploratory surgery after screening, and of those who did, one in three turned out to have an invasive cancer.
The method "is starting to look very, very promising," said the study's leader, Dr. Karen Lu of the University of Texas M.D. Anderson Cancer Center in Houston. She gave results Thursday in a telephone briefing and will present them next month at an American Society of Clinical Oncology conference.
Federal grants and several foundations paid for the study. Lu's colleague, Dr. Robert Bast, helped invent the $150 blood test used in the study and gets royalties from its maker, Fujirebio Diagnostics Inc.
Other experts unconnected with the work said the results were encouraging.
"Not too many women were referred for unnecessary surgery," and all of the aggressive cancers that were detected were found in an early, curable stage, said Dr. Laura Havrilesky, a women's cancer specialist at Duke University.
Ovarian cancer is so deadly because nearly 80 percent of cases are found at an advanced stage. About 21,550 women were diagnosed with it, and 14,600 died in the U.S. last year. When found early, five-year survival is 94 percent, according to the American Cancer Society
Researchers have been testing CA-125, a protein in the blood that is high in many but not all women with ovarian cancer. It can be high for many reasons — uterine fibroids, harmless cysts and even other types of cancer — so it's not accurate enough to be used alone for screening.
The new study tested it as a first step for screening 3,252 women, ages 50 to 74, with no strong family history of breast or ovarian cancer. All had a baseline test and were grouped as low, medium or high risk based on their initial CA-125 levels and how much those levels changed over time.
The low risk group repeated the blood test in a year. The middle group got another test in three months.
Those at high risk — about 1 percent of women each year — were referred for an ultrasound exam, which costs around $300, to look for signs of cancer.
Over nine years in the study, 85 women were sent for the exams, and eight ultimately had exploratory surgery to see if they had cancer. (Unlike many other forms of cancer, doctors can't do a biopsy for ovarian cancer without an operation).
Five of the eight women who had operations turned out to have cancer: Three had aggressive tumors, and two had cancer that had not yet become invasive. The other three had benign tumors. Two noninvasive cancers were missed by screening.
"We only needed to do three surgeries to pick up one case of invasive cancer," Lu said.
"That sounds a lot more acceptable" than the 10 surgeries needed to detect one case that a previous study found when using the blood test by itself, said Dr. Otis Brawley, the Cancer Society's chief medical officer.
"This may very well be getting closer to something useful," Brawley said of the new screening approach.
The real test, though, is whether it saves lives — what the study of 200,000 women in the United Kingdom will show.
Dianne Klefstad, 61, of Houston, is betting it will. She took part in the U.S. study, and her tumor was found after her fourth blood test.
When doctors said she had cancer, "I couldn't believe it. I had no symptoms," she said. The screening "saved my life, I think."
Thanks Silver for sharing your indepth knowledge. I hope Rene and Mark are paying attention to what you are saying.
All the promises that great news is coming in later announcements reminds me of the joke about the couple that got married and the bride remained a virgin because all the groom did was sit on the edge of the bed and tell her how great it was going to be.
Good observations.
Do you think that high speed traders, who love volatility, are active in the OTCBB small stocks also?
This is from the NYT:
http://dealbook.blogs.nytimes.com/2010/05/17/speedy-new-traders-make-waves-far-from-wall-st/?scp=2&sq=high%20speed%20trade&st=cse
"Over the last decade, these high-tech operators have become sort of a shadow Wall Street — from New Jersey to Kansas City, from Texas to Chicago. Depending on whose estimates you believe, high-frequency traders account for 40 to 70 percent of all trading on every stock market in the country. Some of the biggest players trade more than a billion shares a day.
These are short-term bets. Very short. The founder of Tradebot, in Kansas City, Mo., told students in 2008 that his firm typically held stocks for 11 seconds. Tradebot, one of the biggest high-frequency traders around, had not had a losing day in four years, he said.
"Showing a computer chart to a visitor, Mr. Narang zeroes in on one stock that had recently been a winner for the firm. Which stock? Mr. Narang clicks on the chart to bring up the ticker symbol: NETL. What’s that? Mr. Narang clicks a few more times and answers slowly: “NetLogic Microsystems.” He shrugs. “Never heard of it,” he says."
1) Of the three groups of natural sellers that you refer to, I understand the first two, but I don't understand the 3rd one: "the ones she's talking to about raising capital". Why would they sell?
2) Is there a fourth category of sellers: the whole stock market is in deep correction mode and many people are running to safety.
3) Isn't the impending application for FDA approval of OvaDx "something tangible to get behind" Arrayit
3)Could it be that Arrayit share prices are on a holding pattern (or downwward slope) until the FDA application is submitted? Could this be a buying opportunity window?
I totally agree Bart. Hopefully FDA approval will fly through.
Good summary Bart.
I just want to add this is from the genomeweb January 08, 2010 article titled "Arrayit Readies Ovarian Cancer Dx for FDA OK, Launches into Full Commercialization Mode"
http://www.genomeweb.com/proteomics/arrayit-readies-ovarian-cancer-dx-fda-ok-launches-full-commercialization-mode
----------------------
"The company is currently designing the clinical trials for OvaDx, but Schena declined to provide further details until after Arrayit has submitted its 510(k) application.
Schena helped the FDA develop its protocols for microarrays as in vitro diagnostic multivariate index assays, and was part of the agency's Microarray Quality Control project. The company has had discussions with the FDA about OvaDx, but officials declined to comment on them."
----------------
It's even more encouraging to know that Dr. Schena is well versed in the FDA process.
No King, I think Silver was referring to my post #758 which accidentally got posted before I had finished editing it. And welcome to the ARYC board by the way. We hope that FDA approval goes much smoother for Arrayit's OvaDX than for IMGG. We are hoping for approval in less than a year, we'll see.
You're right and more info is hard to get even form the required reports. Yesterday Arrayit gave "Notification that Quarterly Report will be submitted late (NT 10-Q)" due to
"Significant disclosures necessary for a complete and accurate 10-KSB are being finalized and reviewed. Staff anticipates filing the 10-KSB within the fifteen-day extension period."
Thanks Silver for giving advice to Arrayit Corp. on some needed changes. I hope they listen. You mention only Rene, but shouldn't Mark also be responsible for running this outfit. Below are the compensation for the key executive officers according to Morningside. John Howell was not listed. Notice the relatively small salary for their PR guy, that could explain their PR disaster LOL.
First figure of comp. is 2008 and the second 2009. Overall the exec team had a raise of 491.5% in 2009.
Key Executive Compensation 415,552 2,459,863
Rene A. Schena/Chairman,Director 45,000 509,321
and CEO
William L. Sklar/Chief Financial 18,000 601,185
Officer, Director
Mark Schena/President, Chief Technology 250,000 750,000
Officer, Secretary; Treasurer, and
Director
Todd J. Martinsky/Vice President 5,707 516,857
and Director
Paul Haje/Director of Advertising 96,845 82,500
and Public Relations
Yes Bart, having the experienced and reputable DOCRO involved is a big plus for Arrayit.
You're right, but to be realistic 6 month review period could easily turn to a year in the world of FDA Approvals.
Regarding the public release of test data results, as you point out Sequenom Inc. (SQNM) did have a nice bounce after they released their pre-natal test for Downs Syndrome data. Their stock more than doubled (from 7.74 to as high as 22) after the announcement. Let's hope the same for Arrayit.
Too bad Sequenom's data turned out to be tainted. See below from the WSJ last week.
"Many on Wall Street cast a cautious eye towards Sequenom, which disclosed in April 2009 that data related to its Down syndrome test were tainted and invalidated all previous statements about its effectiveness. Five months later, the company fired its chief executive and head of research, among other steps, in an attempt to move beyond the issue.
It is still facing an investigation of the matter by the U.S. Securities and Exchange Commission and the Department of Justice.
Before the scandal, the stock was around $15. Afterwards, shares mostly have been below $5. In recent trading, the stock dropped 13.8% to $4.83"
"If so, we are looking at FDA approval for OvaDx by end of 1st QTR 2011 at the earliest."
Make that ....If so, we are looking at FDA approval for OvaDx by end of 3rd QTR 2011 at the earliest
Looking at the milestones of the FDA approval process of OVA1, it went like this:
Submission of 510K for FDA approval - 6/25/2008
FDA approval - 9/11/2009
Test available for general use - 3/9/2010
I wonder if Arrayit's OvaDx will take this long too. If so we are looking at FDA approval for OvaDx by end of 1st QTR 2011 at the earliest.
Another example that he ovarian cancer test market is very hungry for new tools. This one uses the HE4 biomarker similar to Quest's.
Abbott Labs Expects to Debut Epithelial Ovarian Cancer IVD Before End of Year
February 08, 2010
By Kirell Lakhman
Abbott Labs before the end of the year plans to debut its Architect HE4 assay, which is designed to help oncologists monitor patients with epithelial ovarian cancer, the most common form of the disease.
Abbott today announced it had submitted the immunoassay for regulatory approval with FDA. The company is betting the blood-based assay will be indicated to help docs "monitor for the recurrence or progression" of epithelial ovarian cancer.
The test, currently an investigational device in the US, is expected to be "the first automated HE4 test available in US," according to Abbott. However, at least one other company, Quest, currently offers an FDA-cleared HE4 biomarker assay indicated to help physicians monitor for recurrence and of epithelial ovarian cancer.
An Abbott spokesperson today told me the company expects the test to win FDA clearance before the end of the year.
The HE4 biomarker is known to exist at "high levels in the blood of some ovarian cancer patients" and is believed to offer what Abbott calls "the highest sensitivity and specificity of any other marker" for the disease. It is also considered to be one of the best single markers for stage 1 of the disease. Less than 20 percent of all ovarian cancers are found in the early stage, according to the American Cancer Society.
According to Abbott, because certain types of ovarian cancers "rarely express HE4," the Architect HE4 "should not be used as a cancer screening test." Rather is designed "to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data."
According to Quest, CA 125 is "currently the serum marker most widely used to monitor therapeutic response and to detect disease recurrence in patients treated for epithelial ovarian cancer." The National Comprehensive Cancer Network "recommends CA 125 measurement before each treatment cycle for women with elevated pretreatment levels," and recommends CA 125 measurement at each follow-up evaluation if the level was initially elevated."
However, CA 125 "is not elevated in all patients with epithelial ovarian cancer; thus, other markers have been sought." One such marker is HE4, which has been shown in studies to have "comparable sensitivity to CA 125 … in postmenopausal women with ovarian cancer."
Other studies have found that HE4 and CA 125 "may be complementary," and some companies have already jumped at that finding. Last summer, Abbott said it has partnered with Fujirebio Diagnostics to co-develop a test for the "early detection of ovarian cancer that gauges levels of the protein serum CA125 and the human epididymal protein 4, or HE4."
Abbott's Architect HE4 assay, which was co-developed with Fujirebio, is already available in Europe, in some Asia-Pacific markets, and Latin America. Separately, Fujirebio last year penned a deal with Becton Dickinson to develop a molecular test based on the HE4 biomarker
http://www.genomeweb.com/blog/abbott-labs-expects-debut-epithelial-ovarian-cancer-ivd-end-year
Silver, you were prophetic when you said on 5/1 when the promotion was in full swing:
"For the regulars here. You may well have been given a nice Xmas present Monday and Tuesday. Take it and then reenter in a week or two. You have been given front row seats to the underbelly of paid stock promotion"
On Monday 5/3, the stock went up to as much as 1.37. About two weeks later (today 5/13) it is at 0.75.
Zero false positives for OvaDX out of some 1000 test is very promising. If they can keep anywhere near that rate in large number of tests, OvaDx will be a knockout and will be able to get FDA approval as a pre-symptomatic screening test. (Don't know what the false negative rate is , but they reported that there have been "several" false negatives, but they expect this to be "very low" once they've refined the test.)
Just for comparison with the other (symptomatic) tests:
- the false positive rate for the CA 125 test alone is between 97 and 99 percent, that is why it has to be used in conjunction with other tests. CA 125 test will come back negative in half of all women who have early ovarian cancer
- OvPlex may reduce the false negative rate of CA125 by up to 19% and the false positive rate by up to 42%. Better than CA125 but not too great.
-OVA1 generates a lot of false positives. Of the women flagged as likely having cancer, 64% didn't, as determined by biopsies done during surgery. The trial funded by Vermillion Inc., of Fremont, Calif., which developed the test, found that physicians' current methods, which generally included another blood test, an exam and imaging, had a false-alarm rate of "only" 40%.
The cost of OVA1 test is $650
An accurate OvaDx test at $350. sounds like a good value. And like you say, $300. is even better.
Thanks Bart and Silver for pointing out the difference between OvPlex™ (for symptomatic women) and Arrayit's OvaDx™ (pre-symptomatic).
Therefore, OvPlex™ is not designed to be used as a population screening test.
Bart and I like your observation that OvaDx could be use not only for screening, but also to monitor the results of ovarian cancer treatment.
I suppose that if OvaDx is FDA approved first that could be the death knell for OvPlex.
BTW, I read somewhere that OvPlex test price is $200.
I saw a post in an ovarian cancer blog where they mention Arrayit's OvaDx. They also make reference to OvPlex another test being marketed by Australia's Healthlinx in Australia and the UK, and which they hope to bring to the US in 2011 if they get FDA approval. The OvPlex is currently 92% efficient and they are fine tuning and hope to be over 97% efficient. I hope Arrayit gets FDA approval first!
"Healthlinx, which launched its test called OvPlex in the UK in February, has said that it may launch the test in the US next year, if it receives regulatory approval."
http://ovariancancerandus.blogspot.com/2010/03/arrayit-signs-on-docro-to-help-ovarian.html
That lead me to this other report in March 26, 2010 / ProteoMonitorin which the Ovarian Cancer diagnostics tool situation is discussed at length:
Healthlinx Launches OvPlex in UK, Heating Up Race to Get Ovarian Cancer Dx to Market
March 19, 2010
By Tony Fong
Australian biomarker and diagnostic firm Healthlinx last month launched its OvPlex test in the UK, as the race to bring ovarian cancer diagnostics to the market warms up.
Melbourne-based Healthlinx launched the five-protein panel in the UK and the Republic of Ireland following its initial introduction in Australia in October 2008, which the company said made OvPlex the world's first protein-based ovarian cancer diagnostic to be commercially available.
This week, Healthlinx announced that its UK distribution partner, Intus Healthcare, had formed a scientific advisory board to "oversee the use and distribution" of OvPlex in the UK.
In addition to the UK, Healthlinx said the firm expects OvPlex to become available in Singapore and other parts of Southeast Asia this year, reaffirming remarks the company made in its 2009 annual report, in which it said that over the next 18 months to two years it "plans to target" China, South Korea, and parts of Eastern Europe for the test. In the report the company added it intends to debut the test in the US in 2011.
After several years of stops and starts and some high-profile setbacks, proteomics-based diagnostics appear to be finally making some headway into the market, led by tests for ovarian cancer. And according to one industry observer, they could grow significantly in the next few years.
Along with Healthlinx, Vermillion last week launched its OVA1 test in the US, while Arrayit is pursuing regulatory approval of its test, OvaDX, in the US. Correlogic also is pursuing approval from the US Food and Drug Administration for its test called OvaCheck.
To be sure, that hardly signals a trend, but as Harry Glorikian from life sciences consulting firm Scientia Advisors, said, "We know there will be quite a bit of new products entering the market. That will affect the strategy of many companies as competition heats up, pricing is affected, and go-to-market plans get adjusted."
Improving on CA125
Healthlinx's OvPlex is based on a panel of five biomarkers detected in blood, including CA125. OvPlex, the company said, is more effective at detecting ovarian cancer than CA125 alone, the current standard for diagnosis.
The other biomarkers comprising OvPlex are C-reactive protein, serum amyloid A, interleukin 6, and interleukin 8. An algorithm generates a score between zero and 1, which corresponds to the likelihood that a woman has ovarian cancer.
When it launched the product in Australia, Healthlinx said that in clinical trials, OvPlex achieved 89.2 percent sensitivity and 93.9 percent specificity. In a study published earlier this year in the Journal of Cancer Research and Clinical Oncology, researchers from HealthLinx and Australian universities and institutions found that OvPlex achieved a sensitivity of 94.1 percent and a specificity of 91.3 percent at a threshold of 0.3 for the validation cohort.
In comparison, CA125 alone had a sensitivity of 92.6 percent and a specificity of 89.6 percent. For overall accuracy, OvPlex achieved 92.7 percent, compared to 91.1 percent for CA125 alone.
In the early-stage cohort, OvPlex achieved sensitivity of 92.3 percent and specificity of 91.3 percent, while CA-125 alone had sensitivity of 89.7 percent and specificity of 89.6 percent.
The company did not respond to several requests for an interview and e-mailed questions, but in the study, the authors wrote that the diagnostic performance for the panel was "significantly greater than the [performance] for CA125 alone for a validation cohort and an early stage disease cohort."
OvPlex is for early stage detection of ovarian cancer and Healthlinx said that the test "has been validated for women who are at higher risk or have symptoms of ovarian cancer."
The company is now in the process of evaluating OvPlex in a larger multi-site trial and possibly including two biomarkers, HTX005, also known as AGR2, and HTX010 "that have shown promise as ovarian cancer biomarkers in preliminary studies," Healthlinx said in its annual report.
The trial will evaluate OvPlex using 1,190 patient samples, and includes collaborators from Mater Health Services in Brisbane, Australia; Young Loo Lin School of Medicine at the National University of Singapore; the South Essex Cancer Network in the UK; and the University of Liverpool in the UK, Healthlinx said in a statement last month.
Last fall, Healthlinx said it had secured A$7.23 million ($6.6 million) to conduct the trial and help commercialize OvPlex. It also was awarded a A$750,000 grant from the Victorian government.
In its annual report, Healthlinx said its objective "is to increase the diagnostic efficiency of OvPlex to greater than 97 percent, and larger trials and testing of additional biomarkers are imperative for achieving this goal."
The trial, it added, "will also see the possibility of partnering the technology with
a larger and more progressive group that can accelerate distribution and regulatory approvals in North American and other strategic jurisdictions."
Its strategy for North America is to partner with a firm with established distribution channels in the "lucrative US market," which it said is the largest in the world for any health product. In addition, any potential partner should have "in-house trials capabilities to assist in study design and regulatory approval processes;" a strong track record in partnering on diagnostic technologies; and the ability to scale up on antibody and ELISA production.
"We are confident that we will secure this partner in the near future and that OvPlex will deliver an incremental health benefit to women globally," the company said. "With the anticipated positive results from the second study, it is our intention that in 2011, OvPlex will be available through our chosen partner to all women in the United States."
More than 8 million CA125 tests are sold in the US, the company said, and OvPlex will directly target that market. Worldwide, 240,000 new cases of ovarian cancer are diagnosed each year and 130,000 women die from the disease, Healthlinx said.
As of the end of its fiscal year, June 30, 2009, sales of the test in Australia had exceeded 200 units since its launch in late 2008, and in the UK, the company said it anticipates selling more than 5,000 units of OvPlex in about the first six months of its launch, Healthlinx said in its annual report.
In support of the launch in the UK, Healthlinx said that Intus Healthcare, its distribution partner in the UK, had formed its scientific advisory board. The members are Amrit Takhar, Malcolm Padwick; Fergus Macpherson; Louise Bayne; and Sean Kehoe.
In addition to OvPlex, Healthlinx is targeting diagnostics for prostate cancer, colorectal cancer, and pancreatic cancer, though those projects have been on hold "due to the credit crunch" caused by the global economic slowdown, the company said.
Healthlinx's lead technology is the Cryptomics platform, which the firm describes on its website as a "novel compound-discovery platform that can significantly accelerate the discovery of novel proteins for nutraceutical and therapeutic use."
In general, the Cryptomics platform "entails a suite of technologies" involving fragmentation mainly by enzymes; LC separation; cell and non-cell-based bioassays to monitor bioactivity of protein fragments; and mass spectrometry for protein fragment identification.
Healthlinx has also developed greater than 200 cryptein libraries from more than 20 material sources, including individual proteins, protein complexes, cell lysates, and body fluids. Proprietary methods were developed by the company in order to create the libraries, Healthlinx said.
According to the Healthlinx's annual report, the firm posted receipts of A$201,216 for fiscal 2009 ended June 30, 2009, down 62 percent from receipts of A$534,788 in fiscal 2008. Loss attributable to members in 2009 rose 36 percent to A$1.9 million from A$1.4 million the year before.
Dx Firms Eyeing Ovarian Cancer
The UK launch of OvPlex is the latest of a sudden flurry of activity surrounding similar proteomics-based tests for ovarian cancer after several false starts. Just last week, Vermillion launched its OVA1 test after becoming the first proteomic in vitro diagnostic multivariate index assay to be cleared by the FDA [See PM 03/12/10]. A five-protein panel, OVA1 can indicate the likelihood of ovarian cancer with high sensitivity before a biopsy or exploratory surgery, Vermillion said [See PM 09/17/09].
In December 2009 Arrayit announced it would be seeking FDA approval for its OvaDx microarray-based test for the screening of ovarian cancer for a market launch sometime this year [See PM 01/08/10]. The company did not provide an update on its application for this story.
Scientia Advisors' Glorikian said that following the entry of genomic molecular diagnostics into the marketplace a few years ago, it was foreseeable that protein-based products would soon follow.
"We said this about four years ago and the prediction was [that] protein-based products would lag by four to five years, so we are entering the window," he told ProteoMonitor by e-mail. "That window, however, shifts depending on the maturity of the area and our understanding of the disease."
Just in the past few years, the number of molecular diagnostics — both genomics- and proteomics-based — in the development pipeline has grown "at an incredible rate and will have a dramatic impact on the practice of medicine," Glorikian added.
If that forecast comes true, it would be a far cry from as recently as a year and a half ago when the future of such protein-based cancer diagnostics looked uncertain at best. It was then that LabCorp launched OvaSure, a six-biomarker test co-developed with researchers at Yale University as a CLIA test in 2008. But under pressure from the FDA, which said the test was under the purview of the agency and therefore was not allowed to be marketed without its approval, LabCorp withdrew the test [See PM 10/30/08].
Before that, Correlogic had been developing its OvaCheck test for the early detection of epithelial ovarian cancer since 2002. That test also ran into a series of snags with the FDA, however, the most recent in 2007 when the agency said it was going to begin regulating tests such as OvaCheck that use algorithms to interpret complex gene and protein data [See PM 02/15/07].
The future of both OvaSure and OvaCheck are unclear. LabCorp did not respond to a request for comment.
In an e-mail, 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.
In the meantime, Healthlinx officials said that the OvPlex puts the company at the forefront of the ovarian cancer diagnostics market.
In a statement, Nick Gatsios, managing director of Healthlinx, said that the UK launch of OvPlex is the first "large-scale rollout" of the test and could trigger launches in other countries of "what we feel is a superior diagnostic for ovarian cancer to any other product available
Related Stories
• Arrayit Signs on Docro to Help Ovarian Cancer Diagnostic Gain FDA Clearance
March 26, 2010 / ProteoMonitor
Bart, maybe they listened to you, today Arrayit had an encouraging press release with promise of more to come.
Thanks for the posting 2010ftw (does ftw stand "for the win"?).
Here is a more streamlined version of the press release. Encouraging info here and they promise more to come.
Arrayit Corporation Reports Strong Surge in Customer Demand for the Company's Leading Edge Life Sciences Microarray Instruments
New 2010 Products and Services Catalog Reaches 11,000 Microarray Scientists Worldwide
SUNNYVALE, Calif., May 10, 2010 (GlobeNewswire via COMTEX) -- Arrayit Corporation /quotes/comstock/11k!aryc (ARYC 0.95, -0.04, -4.04%) , a leader in life sciences and healthcare technology, reports today a strong surge in customer demand for the company's leading edge life sciences microarray instruments. On Friday May 7th, the company quoted 17 instruments representing $1.2M in total revenue. The increase coincides directly with the first deliveries of the new Arrayit 2010 catalog sent by mail to 11,000 life sciences professionals worldwide.
Arrayit Corporation CEO Rene Schena stated, "We are pleased by the positive and immediate customer response. Our commitment to life sciences instrumentation is an important driver for revenues growth in 2010."
Arrayit's life sciences instruments empower scientists and clinicians to explore fundamental challenges in basic research, agriculture, and medicine, including deciphering the molecular basis of human diseases. Arrayit microarrays are manufactured by depositing nearly invisible spots of genes, proteins, and patient DNAs onto glass substrates, and then reacting the microarrays with labeled samples isolated from living cells and other sources. The microarrays are processed and read using computer-controlled hybridization stations and high-speed fluorescence scanners to produce digital genomic and proteomic data. Arrayit's instruments are "best-in-class" based on unparalleled performance, versatility, and ease-of-use.
Arrayit Corporation President and Chief Science Officer Mark Schena said, "The widely adopted Arrayit platform with its unique technological attributes, including the proprietary H25K complete human genome chip, provides results that are unrivaled by other platforms. Arrayit microarrays and instruments offer richer content and greater sensitivity than competing platforms, and these attributes have allowed us to discover the world's only definitive pre-symptomatic biomarkers for ovarian cancer and Parkinson's Disease, as well as a new pharmaceutically important pathway in human biology that will be the subject of future announcements."