Fujirebio Diagnostics, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted 510 (k) clearance to the CYFRA 21-1™ EIA assay to monitor disease progression during the course of disease and treatment of lung cancer patients. This is the first biomarker assay kit to be cleared by FDA for use in the management of patients with lung cancer.
Press releases and announcements from Fujirebio US
Fujirebio, a Miraca Holdings group company, has completed the acquisition of all of the issued and outstanding shares of Innogenetics NV. The acquisition was consummated in accordance with the terms and conditions of the definitive agreement that had been referred to in Fujirebio's previous release ("Fujirebio to acquire Innogenetics from Abbott") dated July 20, 2010.
Fujirebio, a Miraca Holdings group company, announced today a definitive agreement with Abbott, the global healthcare company, to acquire all of the issued and outstanding shares of Innogenetics, a multi-national company that develops and markets a wide range of specialty diagnostics in the fields of infectious diseases, genetic testing, transplantation as well as neuro-degeneration.
BD (Becton, Dickinson and Company; NYSE: BDX) and Fujirebio Diagnostics, Inc., announced today the signing of a worldwide development and supply agreement for oncology diagnostic assays.
Fujirebio Diagnostics, Inc. and Abbott have signed a license agreement to develop a new ovarian cancer test for use on Abbott's automated ARCHITECT® diagnostic analyzers. Under the agreement, Fujirebio Diagnostics will develop and manufacture for Abbott the HE4 biomarker, a simple blood test that may help in the risk stratification of women at high risk for ovarian cancer, a difficult disease to detect in its early stage.
A pivotal clinical trial published in the January 2009 issue of the journal Gynecologic Oncology demonstrated the utility of combining Fujirebio Diagnostics' HE4 and the CA125 test as an aid in estimating the risk of epithelial ovarian cancer in premenopausal or postmenopausal women presenting with pelvic mass. The HE4 test, which is under review by the U.S. Food and Drug Administration (FDA), was reported to successfully stratify patients into high- and low-risk groups when combined with CA125.
Fujirebio Diagnostics' HE4 Test will be Available Through Roche Diagnostics' Automated Immunoassay Analyzers.
Fujirebio Diagnostics Inc., a Malvern-based company, was recently named one of the Best Places to Work in PA for 2008 in a statewide survey and awards program created by a public/private partnership of Team Pennsylvania Foundation, the Pennsylvania Department of Community and Economic Development, the Pennsylvania Chamber of Business and Industry, and the Central Penn Business Journal.
The HE4 assay is CE marked in Europe and will be available to US-based physicians in July.
Company Broadens Product Portfolio with Assay Controls, Ignites Drive for Growth in Disease Diagnostics