The Week In Diagnostics


Study to examine genetic testing for warfarin dosing

Seattle-based company Iverson Genetic Diagnostics, Inc. has reported that the WARFARIN Study (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation) has been started at the Franciscan Health System in Tacoma, Washington and other major hospital systems nationwide. The study will assess the utility of genetic testing to determine a personalized warfarin dose for individual patients to help reduce their risk of serious bleeding or clotting events. The 18-month study will determine patients’ rates of warfarin-related adverse events at 30, 60 and 90 days from initial warfarin dosing.

AML bioimarkers

Skyline Diagnostics B.V. and Clavis Pharma ASA announced that they have signed a research agreement under which Skyline will investigate gene expression biomarkers for selection of individual Acute Myeloid Leukemia (AML) patients that may benefit from a new AML drug in development at Clavis. The drug, elacytarabine, is an elaidic acid derivative of cytarabine and currently undergoing the CLAVELA phase III study for treatment of patients with relapsed/refractory AML.

In the News…

SuperNova Diagnostics®, Inc., a diagnostics company for human and non-human health applications, will be presenting at the Rodman & Renshaw Global Investment Conference on September 13, 2011 from 10:50 -11:15 am EDT in the Metropolitan West room of the Waldorf-Astoria in New York, NY. A live webcast and 90 day archive of the presentation will be available at

The FDA has given the “green light” for Fujirebio Diagnostics to market its HE4 Test in an algorithm called ROMA™ to aid in assessing whether a premenopausal or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. HE4 has been shown to be elevated in epithelial ovarian cancers (EOC), the most common type of ovarian cancer, but is not elevated in many benign gynecologic diseases. Combining physician assessment with the independently validated ROMA algorithm enables physicians to identify those patients at high likelihood of malignancy who should have their surgery performed by a gynecologic oncologist.

-Peter Winter

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