FDA clearance 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. Helix Obtains FDA Authorization for Exome Sequencing Platform, Alzheimer's Disease Risk Test The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others. Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs. 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 Oct 2, 2019 Cepheid Xpert BCR-ABL Ultra Leukemia Monitoring Test Gets FDA Clearance Oct 1, 2019 FDA Clears Luminex Aries MRSA Assay Load More Breaking News Enzo Biochem, CLX Health Partner to Support COVID-19 Testing for International Travel Type 1 Diabetes GWAS, Fine-Mapping Leads to New Genetic Loci, Potential Drug Targets LSU Health Sciences Center Wins $2.4M to Lead SARS-CoV-2 Variant Sequencing Program NanoString Technologies, Parker Institute for Cancer Immunotherapy Partner on Cell Therapy Project BGI Americas Collaborating With Champions Oncology on Proteomic Cancer Research Personal Genome Diagnostics Inks Cancer Genomic Profiling Deal with Duke University Health System The Scan Missed Early Cases A retrospective analysis of blood samples suggests early SARS-CoV-2 infections may have been missed in the US, the New York Times reports. Limited Journal Editor Diversity A survey finds low diversity among scientific and medical journal editors, according to The Scientist. How Much of a Threat? Science writes that need for a provision aimed at shoring up genomic data security within a new US bill is being questioned. PNAS Papers on Historic Helicobacter Spread, Brain Development, C. difficile RNAs In PNAS this week: Helicobacter genetic diversity gives insight into human migrations, gene expression patterns of brain development, and more.