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October 1, 2013
Press Release: Miraca Holdings Announces Name Change of Innogenetics to Fujirebio Europe
Tokyo, Japan and Ghent, Belgium: Miraca Holdings Inc., a Japan-based holding company in the healthcare sector listed on the Tokyo Stock Exchange, today announcedthat its affiliate Innogenetics N.V. will change its name to Fujirebio Europe N.V. with immediate effect.
September 6, 2011
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.
May 31, 2011
Press Release: Fujirebio Diagnostics, Inc. Receives FDA 510 (k) Clearance for First Biomarker to Monitor Lung Cancer
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.
July 20, 2010
Fujirebio to acquire Innogenetics from Abbott
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.
May 4, 2009
BD and Fujirebio Diagnostics Sign Worldwide Agreement to Develop Biomarker Assays to Improve Cancer Detection and Management
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.
January 27, 2009
Fujirebio Diagnostics and Abbott Agree to Develop New Ovarian Cancer Test for Abbott's ARCHITECT® Analyzers
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.
January 26, 2009
Pivotal Data Published for First Biomarker Combination Test to Determine Risk of Ovarian Cancer in Women Who Present With Pelvic Mass
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.
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