Press releases and announcements from Fujirebio US

Malvern, PA February 14, 2019 – Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., has received Breakthrough Device Designation (formerly known as Expedited Access Pathway (EAP) designation) from the Center of Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on February 1, 2019 for the Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test.  The Breakthrough Devices Program is designed to expedite the development and review of certain medical devices that provide for more effective treatment or diagnosis of

Malvern, PA (June 12, 2018) – Fujirebio Diagnostics, Inc., a consolidated subsidiary of Miraca Holdings Inc., has received U.S. Food and Drug Administration (FDA) clearance of the company’s Lumipulse® G B•R•A•H•M•S PCT Assay for testing on its LUMIPULSE® G1200 immunoassay platform.

Fujirebio Inc., a consolidated subsidiary of Miraca Holdings Inc., (Head office: Shinjuku-ku, Tokyo, President and CEO: Yoshihiro Ashihara, hereinafter “Fujirebio” or “the Company”) announced today that it has entered into an agreement with US-based Janssen Pharmaceuticals, Inc.

Exton, Pa.,  Sept. 5, 2017-- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it entered into a collaboration and license agreement with Fujirebio Diagnostics, Inc. (Fujirebio Diagnostics) to validate and commercialize the CA125 II assay for use on the Lumipulse® Instrument System as a companion diagnostic to aid in the selection of ovarian cancer patients who may best respond to Morphotek’s investigational antibody, farletuzumab.

Malvern, PA, USA - November 14, 2016 - Fujirebio is a Silver Level Sustaining member of APHL (Association of Public Health Laboratories). 

Fujirebio US, Inc. now offers the LUMIPULSE G1200, a robust mid-sized fully automated immunoassay instrument. The LUMIPULSSE G1200 is FDA cleared and offers clinical laboratories a unique and user friendly system with multiple features to simplify workflow.

Miraca Holdings Inc., a Japan-based holding company in the healthcare sector listed on the Tokyo Stock Exchange, today announced that its affiliate Innogenetics N.V. will change its name to Fujirebio Europe N.V. with immediate effect.

Fujirebio Diagnostics, Inc. has been named one of the Best Places to Work in PA for 2011. The “Best Places” program is a public/private partnership between Team Pennsylvania Foundation, the Pennsylvania Department of Community and Economic Development, the Pennsylvania State Council of the Society for Human Resource Management, and the Central Penn Business Journal.

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.

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.

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