This story has been updated from a previous version to include information on Osmetech's respiratory pathogen test panel.
Osmetech has signed a deal to provide instrumentation and support for a US trial of anticoagulants sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, the company said recently.
Under the terms of the agreement, Osmetech will provide 10 out of 12 sites taking part in the study, called the Clarification of Optimal Anticoagulation through Genetics Trial, with its warfarin sensitivity tests and its eSensor XT-8 molecular diagnostics instrument. Autogenomics will be providing tests for the other two sites.
The COAG study attempts to understand the relationship between a patient’s genetic makeup and his or her response to warfarin. The ultimate goal is to obtain information that can guide physicians in prescribing effective warfarin dosages for their patients. COAG is expected to last four years and will generate profiles from roughly 1,200 patients who are beginning warfarin treatment, according to NHBLI. The study is being coordinated by researchers at the University of Pennsylvania.
UPenn's Stephen Kimmel, the lead investigator of the COAG study, said in a statement that the group "considered a number of alternative products and technologies" for the effort, and "took into account a number of factors including product performance and users’ experiences." Kimmel did not respond to an e-mail seeking further comment.
Osmetech CEO James White told BioArray News this week that the company snagged the deal with NHBLI because its XT-8 system has already gained 510(k) clearance by the US Food and Drug Administration for clinical use. Osmetech had the assay cleared last July. Since then, it has submitted an expanded warfarin sensitivity detection panel for clearance (see BAN 7/22/2008).
"It became clear that [the COAG study] was looking [for] FDA-cleared systems with a rapid turnaround time of less than four hours," White said. "There were 12 hospitals preparing to run samples for the study, and 10 of those 12 hospitals, when given the option of FDA-cleared systems, chose to work with Osmetech," he said.
The other two sites decided to use Autogenomics' Infiniti warfarin sensitivity detection assay, cleared by the FDA in January 2008.
For London-based Osmetech, which has offices in Rockland, Mass., and Pasadena, Calif., the deal represents an opportunity to both contribute to the study and potentially win some new customers. White said he hoped that the COAG study would eventually "prove, beyond a doubt, that [warfarin sensitivity] is an important test." White added that Osmetech is "hopeful that the 10 labs will be running some of its [other] tests over time as well."
Warfarin, marketed as Coumadin by Bristol-Myers Squibb, is used to reduce blood clotting, but must be dosed properly to avoid dangerous complications from overdosing, as well as ineffectiveness from underdosing.
It is known that patients with certain variations in the CYP2C9 and VKORC1 genes are a higher risk of adverse side effects from the drug and might therefore need a lower warfarin dose than patients without those variations. In light of this data, the FDA in 2007 updated the label for warfarin to include information about how genotypes may impact patient response to the drug.
However, the FDA did not require physicians to test for those variants before prescribing warfarin, and said that further research would be required to establish an algorithm that would determine dosing for the drug based on genotype information.
The COAG trial will test two approaches to determining the initial dose of warfarin in patients who are expected to need therapy for three months or longer. Half of the participants enrolled in COAG will be selected to have their initial dose determined by clinical information alone, while for the other half of the participants, the initial dose will be determined by using the clinical factors as well as information about his or her variants of the CYP2C9 and VKORC1 genes. All participants will be monitored for up to six months.
White said that he hopes that the COAG study results will lead to tests like those provided by Osmetech "being integrated into the standard care of patients."
The potential market opportunity for these tests would be sizable. Around 2 million people are initiated on warfarin therapy each year, and the FDA has said that complications from the drug are the second most common reason for patients to go to the emergency room, behind adverse reactions from insulin.
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Osmetech's test menu trends towards the pharmacogenomics arena. The company has tests planned for cytochrome P450 2C9 and 2D6 detection as well as Factor V/ Factor II prothrombin detection assays. However, the company recently moved into the pathogen detection space by developing a respiratory pathogen test panel.
The panel, which is expected to be launched as a research product next quarter, detects and differentiates between 18 common bacterial and viral infections, including the Influenza A virus and its H1N1 subtype, according to the firm. The company submitted last month an emergency use authorization request with the US Food and Drug Administration for permission to sell the test to clinicians in light of the global swine flu outbreak.
Osmetech is currently developing an extension to the respiratory pathogen test that will differentiate this H1N1 subtype between the human and swine forms of the virus, the company said. The test has been adapted from Qiagen’s QIAplex-based respiratory viral test for use on the XT-8. Osmetech and Qiagen inked a deal regarding the assay in September 2008 (see BAN 9/23/2008).
White said that Osmetech's decision to move into infectious disease testing was partly strategic and partly coincidence. "Our view is that we have an FDA-cleared system and we have been collecting data from the respiratory panel we licensed from Qiagen," he said. "So, it was opportune timing."
White said that Osmetech was able to file an EUA with the FDA relatively quickly because the panel had already been optimized prior to the swine flu outbreak. A number of other companies, such as InDevr, CombiMatrix, and Arrayit all have submitted or are considering the submission of EUAs for H1N1 assays (see BAN 5/5/2009).
"It took us three months to get that up and running and generating data," White said of the panel. "If we tried to build a panel from scratch, that would be hard to achieve, but by partnering with those who did better work in the field, we thought we'd work with them by using our detection system," he said.
"The main focus for us continues to be on genetics and personalized medicine," but infectious disease testing is "one area where there are a limited number of technologies that can achieve the robustness that we can achieve with electrochemical detection," White added.