regulatory approval Guardant Health Receives New York State Approval for Guardant Reveal MRD Test The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer. Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions. Binx Health Chlamydia and Gonorrhea Test CLIA Waived The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver. Illumina Receives Medical Device Registration in Russia for NextSeq 550 Dx Sequencer, Reagents R-Pharm, Illumina's strategic partner in Russia and the Commonwealth of Independent States (CIS), led the registration process with the Russian regulatory agency. OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval The company's cartridge for pneumonia for the Unyvero system is under review and pending approval by Chinese regulators. Feb 25, 2021 Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch Premium Jan 19, 2021 MiRxes Receives CE Mark, Singapore Regulatory Approval for Multiplex SARS-CoV-2, Flu Test Dec 2, 2020 China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis Nov 13, 2020 FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer Nov 11, 2020 OpGen Posts 70 Percent Increase in Q3 Revenues Amid Shuffling of Portfolio Nov 9, 2020 FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza Oct 29, 2020 Roche EGFR Mutation Test Approved by FDA as Companion Diagnostic for NSCLC Oct 27, 2020 FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Three Targeted Therapies Oct 26, 2020 FDA Approves Foundation Medicine CDx, Bayer's Vitrakvi for NTRK Patients Sep 8, 2020 FDA Approves Thermo Fisher Scientific CDx for Genentech's Gavreto in NSCLC Patients With RET Fusions Aug 31, 2020 T2 Biosystems Gets FDA EUA for SARS-CoV-2 Molecular Diagnostic Test Aug 27, 2020 Amoy Diagnostics, Haihe Pharmaceutical Ink Agreement to Codevelop CDx for Lung Cancer Treatment Aug 27, 2020 Foundation Medicine Liquid Biopsy Gets FDA Approval for Multiple Companion Diagnostic Indications Aug 7, 2020 Guardant Health CDx Wins FDA Approval for First Liquid Biopsy NGS Tumor Profiling Assay Jul 22, 2020 Devyser Gains CE Mark for NGS Hereditary Breast and Ovarian Cancer Test Jul 13, 2020 Vela Diagnostics Automated Coronavirus Test Gets CE-IVD Mark Jun 18, 2020 Promega Maintains Microsatellite Instability IVD Plans Amid Evolving Cancer Test Landscape Premium Jun 17, 2020 FDA Approves Merck's Keytruda, Foundation Medicine CDx for TMB-High Solid Tumors Jun 10, 2020 Sysmex Obtains Japan Marketing Approval for Use of Saliva With Coronavirus Kit May 28, 2020 Quest Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Self-Collection Test Kit Load More Breaking News Alzheimer's Disease Phosphoproteomics Study Uncovers Signaling Abnormalities Genetic Analysis of H. Pylori Indicates Americas Colonized in One Main Migration Event BillionToOne Raises $55M in Series B Financing GeninCode to Launch Cardiovascular Disease Risk Tests in US With Eversana Top Five Articles on GenomeWeb Last Week: Illumina, Liquid Biopsy, Thermo Fisher Scientific, and More Becton Dickinson Sues Beckman Coulter Over Cell Analysis, Sorting IP The Scan Another Resignation According to the Wall Street Journal, a third advisory panel member has resigned following the US Food and Drug Administration's approval of an Alzheimer's disease drug. Novavax Finds Its Vaccine Effective Reuters reports Novavax's SARS-CoV-2 vaccine is more than 90 percent effective in preventing COVID-19. Can't Be Used The US Food and Drug Administration says millions of vaccine doses made at an embattled manufacturing facility cannot be used, the New York Times reports. PLOS Papers on Frozen Shoulder GWAS, Epstein-Barr Effects on Immune Cell Epigenetics, More In PLOS this week: genome-wide association study of frozen shoulder, epigenetic patterns of Epstein-Barr-infected B lymphocyte cells, and more.