FDA clearance 23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance. FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug The Oncomine Dx Target Test will be used as a companion diagnostic to identify NSCLC patients whose tumors carry EGFR Exon20-insertion mutations. Immunexpress Receives FDA 510(k) Clearance for Sepsis Assay The assay, which runs on the company's Idylla platform, distinguishes sepsis from noninfectious systemic inflammation. FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug The Oncomine Dx Target Test can now be used to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for ivosidenib. Invitae Writes off $262.5M Liability Upon Failure to Meet Regulatory Milestone The company still expects the Stratafide cancer test to achieve FDA approval or clearance, but after March 31, 2022. May 28, 2021 FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen Apr 21, 2021 FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing Apr 13, 2021 Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit Jan 11, 2021 Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test Dec 9, 2020 Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test Sep 8, 2020 FDA Clears DiaSorin Test for Influenza, RSV Sep 8, 2020 Roche BK Virus Test Garners FDA Clearance Aug 24, 2020 Streck Gets FDA De Novo Clearance for Blood Collection Tube With Guardant Health Liquid Biopsy Assay Aug 6, 2020 Adaptive Biotechnologies Receives Expanded FDA Clearance for ClonoSeq MRD Assay Jul 22, 2020 BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx Jul 18, 2020 Quest Diagnostics Gets First FDA EUA for SARS-CoV-2 Testing With Pooled Samples Jun 18, 2020 FDA Approves Epizyme's Tazverik, Roche CDx for EZH2-Mutated Follicular Lymphoma Patients May 13, 2020 Adaptive Eyes NGS-Based Test for T Cell Response in COVID-19 Premium Apr 27, 2020 FDA Clears Cancer Genomic Profiling Kit From Personal Genome Diagnostics Apr 13, 2020 Rutgers Gets FDA EUA for Modified Thermo Fisher Coronavirus Assay for Use With Saliva Samples Apr 1, 2020 FDA Proposes Reclassification of HCV RNA, Antibody Tests Mar 31, 2020 Qiagen Receives FDA Emergency Use Authorization for SARS-CoV-2 Respiratory Panel Mar 13, 2020 FDA Issues Emergency Use Authorization for Roche SARS-CoV-2 Test Feb 23, 2020 Asuragen Fragile X Diagnostic Test Gets FDA Authorization Jan 22, 2020 OraSure's DNA Genotek Gets FDA Clearance for Sample Collection Kits Load More Breaking News New Approach Identifies Candidate Causal Variants for Neuropsychiatric, Neurodevelopmental Conditions People in the News: Baylor's Thomas Caskey Dies; New Appointments at UK Biobank, CS Genetics, More In Brief This Week: Pathogenomix, Uniogen, Genetic Technologies, DnaNudge, Gravity Diagnostics, More New Products Posted to GenomeWeb: Biodesix, Curio Genomics, Akoya Biosciences, More NIH Earmarks $170M for All of Us Program's Personalized Nutrition Study Taiwanese Firm's IP Asserted in Suit Against Pacific Biosciences Found Partially Unpatentable The Scan Omicron's Sewage Path The New York Times writes that testing sewage is helping public health officials track Omicron. IBM Sells Part of Watson Health The Wall Street Journal reports IBM is selling part of its Watson Health business to an investment firm. Identifying the Right Whales The Boston Globe writes that genetic testing has helped identify North American right whales and find that weaning can take place earlier than thought. Science Papers on Approach to Quickly Sort Single Cells, Alternative Splicing in Cancer In Science this week: high-speed sorting of single cells using fluorescence imaging, and more.