Regulatory News & FDA Approvals The latest regulatory news and FDA approvals. T2 Biosystems, Vanderbilt University Medical Center Partner on Prospective Bacterial Sepsis Dx Study The medical center will evaluate whether the T2Bacteria Panel improves antibiotic usage and clinical interventions for sepsis patients. Acutis Diagnostics Gets FDA Emergency Use Authorization for COVID-19 RT-PCR Test The test is designed to detect SARS-CoV-2 in nasopharyngeal swab specimens from people suspected of having COVID-19. FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway. Sysmex Gets Approval in Japan for Retinal Dystrophy Gene Panel The next-generation sequencing panel identifies genetic mutations that cause inherited retinal dystrophy, which results in vision problems, including blindness. Cepheid Nabs CE-IVD Mark for Molecular NPM1 Mutation Test for AML Monitoring The test quantifies mutant NPM1 mRNA transcripts in peripheral blood specimens from patients with acute myeloid leukemia. May 19, 2023 Hologic Nabs FDA 510(k) Clearance for Respiratory Assay May 11, 2023 Invivoscribe Leukemia CDx Assay Nabs IVDR Approval May 9, 2023 BioMérieux Gets CLIA Waiver for BioFire SpotFire Respiratory Panel Mini May 9, 2023 Cue Health Submits At-Home Molecular RSV Assay to FDA May 8, 2023 Devyser Gets CLIA Certification for Atlanta Lab May 5, 2023 FDA Issues EUAs for COVID Molecular Tests From Access Medical, Drexel University May 4, 2023 Nucleix Bladder EpiCheck Cancer Liquid Biopsy Test Gets FDA 510(k) Clearance May 1, 2023 CMS Announces Upcoming Changes to COVID-19 Test Reimbursement Policies May 1, 2023 Tempus Gains FDA Premarket Approval for NGS Solid Tumor Profiling Test Apr 27, 2023 FDA Grants Emergency Use Authorization for UMass Amherst COVID-19 Molecular Test Apr 25, 2023 MedArbor Diagnostics Gets FDA Emergency Use Authorization for COVID RT-PCR Test Apr 25, 2023 Mawi DNA Gets 510(k) for SARS-CoV-2 Sample Collection Kit Apr 19, 2023 Syantra Obtains CE-IVD Mark for Breast Cancer Test Apr 18, 2023 Myriad Genetics, Intermountain Precision Genomics Obtain NY Certification for Solid Tumor Testing Apr 18, 2023 OpGen Seeking FDA Marketing Authorization for Urinary Tract Infection Panel Apr 3, 2023 US Federal Trade Commission Orders Illumina to Unwind Grail Acquisition Mar 28, 2023 Lucira Health Combo Flu/COVID-19 MDx Test Gets Regulatory Approval in Australia Mar 20, 2023 Cue Health Gets FDA EUA for Monkeypox Molecular Test Mar 20, 2023 DiaSorin Gets FDA 510(k) for Molecular COVID-19/Flu Assay Mar 16, 2023 Becton Dickinson Gets FDA 510(k) Clearance for High-Throughput Vaginitis Test Load More Breaking News Helix, St. Luke's University Health Network Partner on Population Health Study Exome Sequencing Study Suggests Early Menopause May Not Be Monogenic New Products Posted to GenomeWeb: Tempus, GenScript, RealSeq Biosciences, 23andMe People in the News at Biocept, Arcensus, TATAA Biocenter, Quantum-Si, LetsGetChecked, More In Brief This Week: Qiagen, Mainz Biomed, Quest Diagnostics, Haystack Oncology, Becton Dickinson The Scan Cystatin C Plays Role in Immunosuppression, Cancer Immunotherapy Failure, Study Finds A study in Cell Genomics provides insight into how glucocorticoids can lead to cancer immunotherapy failure via cystatin C production. Aging, Species Lifespan Gene Expression Signatures Overlap An Osaka Metropolitan University team reports in Nucleic Acids Research that transcriptional signatures of aging and maximum lifespan have similarities. Splicing Subgroup Provides Protocols for Evaluating Splicing Variant Data The group presents their approach on how to apply evidence codes to splicing predictions and other data in the American Journal of Human Genetics. Single-Cell Transcriptomic Atlas of Mouse Cochlea to Aid Treatment Development Researchers in PNAS conducted single-cell and single-nuclear sequencing of about 120,000 cells at three key timepoints in cochlear development to generate a transcriptomic atlas.