ResourcesVendorsFujirebio205 Great Valley Parkway Malvern, PA, USA 19355Latest from FujirebioAlzheimer'sFujirebio introduces blood-based RUO Alzheimer’s assaysBy LabPulse.com staff writersThe assays, which are for the quantitative measurement of E4 isoform of the apolipoprotein E (ApoE4) and all isoforms of the same protein (Pan-ApoE), respectively, extend Fujirebio’s current portfolio of RUO biomarker assays for the Lumipulse G system.March 31, 2023Business InsightsWeek in Review: QuidelOrtho de novo authorization | Veracyte growth plans | Abbott concussion test clearanceBy Leo O'ConnorThe FDA granted clearance to Abbott for the first commercially available laboratory test to detect concussion and a de novo request allowing QuidelOrtho to market its Sofia 2 SARS Antigen+ FIA test for use by prescription only.March 9, 2023Alzheimer'sAriBio, Fujirebio partner on biomarker development for Alzheimer’s, other neurodegenerative disordersBy LabPulse.com staff writersThe agreement will provide Fujirebio access to clinical samples and data that have been collected in an ongoing phase III Alzheimer’s disease study being conducted by AriBio.March 8, 2023Molecular DiagnosticsFujirebio Europe secures distribution rights for Self-Screen's methylation-specific molecular assayBy LabPulse.com staff writersThe test identifies women at high risk by detecting elevated methylation levels of cancer biomarkers, Fujirebio said, adding that it has been validated for both physician sample collection and sample self-collection.October 11, 2022Alzheimer'sFDA grants approval for Fujirebio assay for Alzheimer's plaquesBy Brian CaseyThe FDA granted clearance under its breakthrough device pathway to Fujirebio's Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is designed to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40. These are proteins that can accumulate and form plaques in the brain; concentrations of these proteins can be detected in cerebral spinal fluid (CSF).May 3, 2022CE markFujirebio files 510(k) for Lumipulse testBy LabPulse.com staff writersThe assay is a semiquantitative IVD test intended to be used in adult patients ages 50 years and older who present with cognitive impairment. The test is to be used in tandem with other diagnostic modalities and is based on ratios of beta amyloid measurements in patients' cerebral spinal fluid.December 1, 2020Emergency Use AuthorizationIVD firms ready high-throughput antigen testsBy Bruce CarlsonCurrently marketed tests are primarily rapid tests performed at the point of care and can be confirmed by polymerase chain reaction (PCR) testing. Several firms now have emergency use authorization (EUA) for rapid antigen tests for COVID-19, and soon a new type of test should be brought to bear: antigen tests on automated systems that can run hundreds of tests per hour. Some of these tests are already marketable in countries that accept the CE Mark.November 22, 2020