A Medical Device Daily

Vermillion (Fremont, California) a molecular diagnostics company, reported that the U.S. Patent and Trademark Office (USPTO) has issued a notice of allowance to the company for the discovery of hepcidin as a biomarker for ovarian cancer.

The discovery could ultimately lead to the development of an improved, next-generation assay that might provide physicians with additional, valuable information to diagnose ovarian cancer.

The patent also covers the measurement of hepcidin by a variety of methods, including mass spectrometry and other immunoassay approaches.

Vermillion has multiple ovarian cancer diagnostic tests in development. The most advanced of its programs is the OVA1 test, which is designed to utilize a panel of biomarkers to help identify women with a higher likelihood of malignancy so they can be referred to a gynecologic oncologist for their initial surgery. Vermillion filed a 510(k) application with the FDA for the OVA1 Test last June.

Additionally, studies are under way to develop tests with the capability of detecting early-stage ovarian cancer, predicting prognosis and recurrence, and identifying women considered at high-risk for the disease.