A Medical Device Daily

Osmetech (Pasadena, California), an international molecular diagnostics company, said it has signed an agreement as principal supplier of Warfarin Sensitivity tests for a major new U.S. trial sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.

Investigators for the upcoming Clarification of Optimal Anticoagulation through Genetics Trial (COAG Trial) have selected Osmetech's Warfarin Sensitivity tests and eSensor XT-8 molecular diagnostics instrument platform for 10 of the 12 sites identified to run the trial. The University of Pennsylvania (Philadelphia) is the coordinating center for the trial.

The study has been designed as a 1,238-patient, randomized, double-blind trial which will examine the utility of using genetic information for warfarin dosing.

Specifically, 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 randomly selected to have their initial dose determined by clinical information alone.

For the other half of the participants, the initial dose will be determined by using the clinical factors as well as information about the participant's genetic makeup, specifically his or her variants of the CYP2C9 and VKORC1 genes. All participants will be monitored for up to six months.

Researchers will assess how long participants in each group maintain the desired level of blood thinning, as determined by a blood test, at two and four weeks after starting therapy, as well as at three and six months. Researchers will also review bleeding problems and other complications, quality of life and cost of therapy.

"The high level of performance of our eSensor XT-8 System and Warfarin Sensitivity test in the market since commercial launch in the second half of 2008 continues to gain recognition and this contract award should further enhance market acceptance of our platform," said James White, CEO of Osmetech. "Osmetech has won an opportunity to participate in a major study which will demonstrate the significance of genetic and clinical data in the prescription of a patient's initial warfarin dose. The strength of our eSensor XT-8 platform and pipeline of tests puts us in an excellent position to benefit from the growing trend towards personalized medicine."

Warfarin is an oral anticoagulant widely used for the prevention of thrombotic events and to treat a confirmed episode of venous thrombosis, with roughly 2 million new patients each year in the US alone. Although highly effective, warfarin's usability is limited by a narrow therapeutic range combined with a pronounced interindividual variability in the dose required for adequate anticoagulation.

Clinical use of warfarin is further complicated by a substantial risk for hemorrhagic side effects, which is increased in patients with low-dose requirements. Warfarin is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalization, according to Osmetech.

In other agreements/contracts news:

• HMS (New York) said it has been awarded a second Medicaid Integrity Program (MIP) task order by the Centers for Medicare and Medicaid Services. HMS will examine payments to providers made under Title XIX of the Social Security Act, with the objective of identifying potential overpayments made as a result of fraud, waste, or abuse.

HMS will perform these services in the CMS Medicaid Integrity Group (MIG) San Francisco jurisdiction, which includes California, Washington, Oregon, Arizona, Alaska, Nevada, Idaho, Hawaii, Guam, American Samoa and the Commonwealth of the Northern Mariana Islands. The contract is valued at $3.2 million for the base year and may be renewed on an annual basis upon a successful performance determination by CMS.

In September HMS was awarded the MIP task order for the MIG Dallas jurisdiction, comprising Texas, New Mexico, Oklahoma, Louisiana, Arkansas, Colorado, Utah, Montana, South Dakota, North Dakota and Wyoming.

With the addition of the San Francisco jurisdiction, HMS is now the CMS Audit Medicaid Integrity Contractor for 22 state and territory Medicaid programs across the country.

• Premier Purchasing Partners (San Diego) reported new agreements for surgical incontinence products have been awarded to Boston Scientific (Natick, Massachusetts), Cook Medical (Bloomington, Indiana), and Bard Urological Division C. R. Bard (Covington, Georgia).

Effective July 1, the agreements are available to acute-care and continuum-of-care members of the Premier healthcare alliance.