Fujirebio and Roche Sign Agreement for new Ovarian Cancer Test

Fujirebio Diagnostics, Inc. and Roche Diagnostics announced a worldwide license and supply agreement for the HE4 ovarian cancer test. Under the agreement, Roche will develop an assay kit utilizing Fujirebio Diagnostics' HE4 test on its automated immunoassay analyzers.

The HE4 test was developed by Fujirebio Diagnostics to be used in conjunction with the company's existing CA125 biomarker, the current gold standard for monitoring ovarian cancer. This combination of biomarkers, as published clinical data shows, provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone.

Improved sensitivity and specificity should allow clinicians to distinguish between benign and malignant pelvic masses more accurately, helping to ensure that patients receive appropriate therapy earlier.

"This novel biomarker HE4 will allow our longstanding partner Roche Diagnostics to provide clinicians worldwide with a much needed tool to better define a pelvic mass, enabling women at higher risk for cancer to see the right physician earlier," said Paul Touhey, President and Chief Executive Officer, Fujirebio Diagnostics.

HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with epithelial ovarian cancer (EOC), and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with pelvic mass.

The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA™) are pending clearance by the United States Food and Drug Administration (FDA) for use in women who present with a pelvic mass.

"The HE4 test is another important pillar of our broad tumor marker test menu. We expect that the HE4 test will contribute significantly to our future growth in the area of oncology," said Dirk Ehlers, Head of Roche Professional Diagnostics.