United States of America

Press Release: 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 IITM)* 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.

Malvern PA, USA - September 6 2011 - 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 IITM)* 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.

> See complete press release (PDF)

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