Fujirebio and Roche sign licensing and supply agreement

Under the agreement, Roche will develop an assay kit utilizing Fujirebio Diagnostics’s 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 provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone, said Fujirebio.

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 are pending clearance by the FDA for use in women who present with a pelvic mass.

Paul Touhey, president and CEO of Fujirebio Diagnostics, said: “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.”