regulatory approval Review of Approval Process Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug. Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay The IVD, intended for use on the Illumina MiSeq Dx, detects somatic mutations in tumor tissue samples to guide the use of anti-EGFR therapy where indicated. September Plans The New York Times reports that the US Food and Drug Administration is aiming for early September for full approval of the Pfizer-BioNTech SARS-CoV-2 vaccine. Push Toward Approval The Wall Street Journal reports the US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines. Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus The assay, which quantifies the human cytomegalovirus viral load in transplant patients, represents a new market opportunity for Hologic's MDx business. Mar 5, 2021 Illumina Receives Medical Device Registration in Russia for NextSeq 550 Dx Sequencer, Reagents Mar 1, 2021 OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval 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 Load More Breaking News 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 FDA Grants Emergency Use Authorization for Northeastern University SARS-CoV-2 Test FDA Revises SARS-CoV-2 Test Emergency Use Authorization Requirements to Account for Variants 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 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.