Biomarker Testing Solutions Announced for the Early Detection of Ovarian Cancer
15 Jun 2012

Gold Standard Diagnostics (GSD) has announced that it is to partner with Fujirebio Diagnostics, Inc to provide HE4 testing for clinical laboratories in the U.S. The collaboration between GSD and Fujirebio provides a complete solution for HE4 testing on the ThunderBolt™ EIA platform.

Detection of the HE4 biomarker gives medical professionals an improved tool for early detection of ovarian cancer. GSD provides an exclusive HE4 EIA testing solution that is certified “ThunderBolt-Ready” ensuring seamless automation on GSD’s ThunderBolt™ EIA platform. HE4 testing enables healthcare professionals to detect ovarian cancer much earlier and increase the probability of cure.

The ThunderBolt™ EIA platform is completely open and has many patented features that allow virtually any assay protocol to be easily and methodically validated. Over 200 assays are “ThunderBolt-Ready”, guaranteeing a quick, easy and effective solution for ELISA automation needs. GSD’s customer service completes the laboratory automation solution.

HE4 improves detection and specificity for detection of ovarian cancer over that of CA125 alone. The Risk of Ovarian Malignancy Algorithm (ROMA™) is a qualitative serum test that combines the results of HE4 EIA, ARCHITECT CA 125 II™ and menopausal status into a numerical score. ROMA is intended 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.

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Sonia Nicholas
Clinical Diagnostics Editor