FDA clearance 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. FDA Approves Amgen's Lumakras for NSCLC Alongside Companion Tests From Guardant Health, Qiagen The approval makes Lumakras the first inhibitor of KRAS, once considered "undruggable," to reach the market for KRAS-mutated NSCLC. FDA Grants EUA to Enzo Biochem Sample Collection Kit for COVID-19 Testing The company said its Ampicollect kit is now available for sample collection as part of COVID-19 testing protocols in the US. Thermo Fisher Scientific Gets FDA EUA for High-Throughput, Automated COVID-19 Test Kit This modular system uses a high-throughput version of the company's Applied Biosystems TaqPath COVID-19 Combo Kit, which received an EUA in March 2020. 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 Dec 17, 2019 FDA Clears DiaSorin Molecular VZV Test Dec 4, 2019 FDA Approves Foundation Medicine CDx for Novartis Breast Cancer Drug Piqray Nov 12, 2019 FDA Clears NantHealth Tumor-Normal Whole-Exome Test Load More Breaking News In Brief This Week: Illumina, Personalis, Proteomedix, and More Ancient DNA Details Population Dynamics Within Andean Tiwanaku Civilization Genomic Data Spanning 2K Years Gives Glimpse of Etruscan Origins, Population Changes People in the News: New Appointments at Hologic, Akoya Biosciences, Caris Life Sciences, More At NSGC, Genetic Counselors Address Race-Based Medicine, Ways to Change New Products Posted to GenomeWeb: Becton Dickinson, Cosmos-ID, OncoDNA, More The Scan US Booster Eligibility Decision The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions. Arizona Bill Before Judge The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction. Additional Genes Wales is rolling out new genetic testing service for cancer patients, according to BBC News. Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.