FDA submission Tempus Submits PMA Application for Tumor Profiling Assay to FDA The firm has submitted companion diagnostic and tumor profiling, and MSI status claims using DNA from FFPE tumor tissue and matched normal specimens. Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer The assay is intended to detect Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year. Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform Premium Angstrom Bio is developing a rapid, scalable coronavirus test that uses nanopore sequencing to detect barcoded PCR products. Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test Premium Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year. Sep 28, 2020 Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer Sep 25, 2020 NIH Awardee MatMaCorp Developing SARS-CoV-2 Molecular Test for Rural Hospitals Premium Sep 23, 2020 Becton Dickinson Submits Premarket Approval Supplement to FDA for HPV Assay Aug 7, 2020 Illumina Sees Expanding Sequencing Market in COVID-19 Response, Despite Short-Term Woes Premium Jul 20, 2020 Sepset Biosciences Leveraging COVID-19 Patient Samples in Study to Validate Sepsis Test Premium Jun 16, 2020 Immunexpress Nabs $599K BARDA Contract to Develop Sepsis Test for Coronavirus Patient Triage Jun 8, 2020 QuantuMDx Receives CE-IVD Marking for SARS-CoV-2 Test May 29, 2020 Fry Laboratories Plans COVID-19 NGS Diagnostic Kit Offering Premium May 13, 2020 Adaptive Eyes NGS-Based Test for T Cell Response in COVID-19 Premium Apr 14, 2020 Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to CDx Status Premium Apr 2, 2020 Siemens Healthineers Developing Molecular Kit for Coronavirus Detection Mar 25, 2020 Sentinel Diagnostics Looks to Expand Global Influence With SARS-CoV-2 Test Mar 11, 2020 Coronavirus Test From GenMark Diagnostics Submitted to FDA for Emergency Use Authorization Feb 24, 2020 Luminex Submits Verigene II Respiratory Assay for FDA Clearance Feb 20, 2020 FDA Releases List of Evidence-Based PGx Variants Jan 21, 2020 Myriad Genetics Files for FDA Approval of BRACAnalysis CDx for Lynparza in Prostate Cancer Jan 14, 2020 BioMérieux Submits 43-Target BCID2 Test to FDA Nov 19, 2019 Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA Sep 12, 2019 Applied BioCode Submits Respiratory Pathogen Panel to FDA Jul 23, 2019 Curetis Submits Lower Respiratory Tract Infection Test for FDA Clearance 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.