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Fujirebio expands its INNO-LiPA® CFTR assay portfolio with the launch of INNO-LiPA CFTR Extra

Fujirebio Europe announces the release of the new INNO-LiPA® CFTR Extra assay for the detection of 18 new disease-causing cystic fibrosis (CF) mutations with a high frequency in local European regions. The release of this new product confirms Fujirebio Europe's strong and permanent engagement in cystic fibrosis testing and its position as one of the world leaders in strip-based diagnostics solutions.

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Fujirebio Diagnostics Receives FDA Breakthrough Device Designation for Lumipulse® G β-Amyloid Ratio (1-42/1-40) Quantitative In Vitro Diagnostic Test

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. 

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Fujirebio Europe announces the availability of the Lumipulse® G pTau 181 and β-Amyloid 1-40 assays extending its offer of fully automated assays as an aid in the early diagnosis of Alzheimer’s disease

Fujirebio Europe today announced the availability of the Lumipulse G pTau 181 and β-Amyloid 1-40 assays for its fully automated LUMIPULSE G immunoassay systems. These CLEIA (chemiluminescent enzyme immunoassay) reagents allow for the quantitative determination of Tau phosphorylated at threonine 181 and β-Amyloid1-40 protein, respectively, in human cerebrospinal fluid (CSF) within just 35 minutes.

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