Fujirebio Diagnostics

Fujirebio Diagnostics, Inc., a subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

Articles by Fujirebio Diagnostics

Fujirebio Diagnostics Files 510(K) with FDA for Lumipulse® G ?-Amyloid Ratio (1-42/1-40) in Vitro Diagnostic Test

Fujirebio Diagnostics Files 510(K) with FDA for Lumipulse® G β-Amyloid Ratio (1-42/1-40) in Vitro Diagnostic Test

Jan 06, 2021|2 min read

byFujirebio Diagnostics

When cleared, Fujirebio’s FDA-designated breakthrough device is expected to be among the first commercially available in vitro diagnostics for patients being evaluated for Alzheimer’s disease in the US