The story previously reported that the test being evaluated is from Rheonix and is based on its CARD technology. In fact, Mayo is developing its own test based on IP from Rheonix but not based on the CARD technology.
NEW YORK (GenomeWeb News) – The Mayo Clinic said on Monday that it has reached an agreement with Rheonix to collaborate on evaluating the performance of a genotyping test for warfarin.
Mayo has licensed IP from Rheonix to develop the test, which will be available to all patients of the clinic and be evaluated for improving anticoagulation therapy. Mayo added that the test will be made available to clients throughout the world through its reference laboratory, Mayo Medical Laboratories.
Separately, Rheonix is developing a test based on its CARD (Chemistry and Reagent Device) system, a microfluidic platform that fully automates all the functions of a molecular biology lab on a small disposable chip. Tony Eisenhut, president of the Ithaca, NY-based firm, told GenomeWeb Daily News that Mayo's test is not based on the CARD technology but eventually would be migrated to the CARD system.
He added that Rheonix plans to submit a 510(k) application for its CARD-based test to the FDA during the fourth quarter.
Mayo's test will help physicians better determine proper dosing of warfarin for individual patients and identify whether they may be at risk of forming blood clots due to subtherapeutic dosing or for severe bleeding due to overdosing of the drug, Dennis O'Kane, associate professor in Mayo's department of Laboratory Medicine and Pathology, said in a statement.
"This new test builds upon Mayo Medical Laboratories' continuing efforts to develop useful, cost-effective tests to assist in providing the best management of warfarin for patients," he added.
Financial and other details of the agreement were not disclosed.