Brian Casey[email protected]MicrobiologyLabPulse.com Microbiology InsiderDear Microbiology Insider,May 17, 2022Alzheimer'sFDA grants approval for Fujirebio assay for Alzheimer's plaquesThe 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, 2022Moderate Complexity TestFDA tightens policy on reviews of lab-developed testsIn a November 15 press release, the FDA said it was withdrawing its policy that directed the agency to not enforce premarket review requirements for LDTs. The agency said it was taking the action to "help ensure that COVID-19 tests are accurate and reliable."November 14, 2021PlagueHouse probe says Trump officials changed COVID-19 testing rulesIn a November 12 press release, the House select subcommittee on the coronavirus crisis included a critique of the performance of neuroradiologist Dr. Scott Atlas as President Trump's special advisor on dealing with the pandemic. The subcommittee, chaired by Rep. James Clyburn (D-SC), is investigating allegations that the U.S. government's response to the pandemic was undermined for political reasons by the Trump administration.November 14, 2021HomeBiden taps Califf to once again lead FDA as commissionerCaliff was a longtime professor at Duke University, where he earned his medical degree in 1978. He was vice president of clinical and translational research at Duke for 16 years; his most immediate position has been senior advisor at Verily Life Sciences and Google Health.NEW: This morning @califf001 will be announced as the new FDA Commissioner.No other choice brings both continuity & exciting new direction at such an important time.November 11, 2021MicrobiologyLabPulse.com Microbiology InsiderDear Microbiology Insider,August 31, 2021SequencingIllumina completes Grail deal, despite lack of European approvalIllumina announced its intent to acquire Grail in September 2020 for $8 billion in cash and stock. The deal would unite Illumina's core expertise in next-generation sequencing (NGS) with Grail's diagnostic portfolio, specifically the Galleri test for more than 50 types of cancer. The deal reunites Grail with Illumina, which spun off Grail four years ago.August 17, 2021InfectiousWith Hitachi deal done, Fujifilm sets sights on healthcare growthThe company's European business will be known as Fujifilm Healthcare Europe, while the U.S. unit has been renamed as Fujifilm Healthcare Americas. The new business will offer a complete line of medical products representing both Fujifilm and Hitachi portfolios.July 1, 2021FDA Warning LetterFDA puts kibosh on use of Innova Medical coronavirus testIn a June 10 notice, the FDA said it had "significant concerns" that the performance of Innova's SARS-CoV-2 Antigen Rapid Qualitative Test had not been proven in clinical studies. Also, the FDA noted that the test had not been authorized or cleared by the agency for commercial distribution in the U.S.June 9, 2021Pathology, histologyVA inquiry finds Ark. pathology chief made 3K errorsLevy was chief of pathology and laboratory medicine at Veterans Health Care System of the Ozarks in Fayetteville until he was terminated in 2018, two years after he had completed a substance abuse program that was ordered after he was accused of working under the influence of alcohol.June 1, 2021Page 1 of 6Next PageTop StoriesValidationImmunovia announces positive results for next-gen pancreatic cancer testDiagnostics company Immunovia announced positive results for the newest generation of its pancreatic cancer test from a model-development study, announcing that the test achieved both its primary and secondary endpoints.CollaborationVertex to pay $25M upfront to scale cell manufacturing technologyLawsuitU.K. Patents Court rules Bio-Techne patents invalid in infringement lawsuitPoint-of-Care TestingScout secures CARB-X grant to advance diagnostic test developmentSponsor ContentVisit our Molecular Diagnostics Community
