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FDA Clears Next-Generation Biomarker Test to Determine Likelihood of Ovarian Cancer in Women Who Present with Adnexal Mass

Fujirebio Diagnostics, the industry leader in oncology biomarker assays, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the company’s HE4 Test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) 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.

OVA1 Blood Test Detects Ovarian Cancer More Accurately Than Medically Accepted CA 125 Method for Evaluating Women with Ovarian Mass

A study published online ahead of print in the June 2011 edition of Obstetrics & Gynecology demonstrated that American College of Obstetrics and Gynecology (ACOG) guidelines for determining the likelihood that an ovarian mass is cancerous prior to surgery would accurately identify more women with ovarian cancer if the OVA1 blood test were used in place of the currently recommended CA 125 blood test. The study builds on prior research that shows accurate assessment of an ovarian mass for cancer prior to surgery can affect both treatment decisions and health outcomes for women with ovarian cancer.

Vermillion Announces Presentation of Positive Ovarian Biomarker Data for Next Generation Test

Vermillion, a molecular diagnostics company, recently announced the presentation of positive preliminary data from its collaboration with Johns Hopkins University School of Medicine to identify biomarkers that improve on the specificity of CA125 for the identification of malignant ovarian tumors. These results were presented at the 42nd Annual Meeting on Women’s Cancer of the Society of Gynecologic Oncologists, March 6-9, 2011 in Orlando, Florida.