FDA submission 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. Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer The submission data highlights Parsortix's ability to harvest circulating tumor cells from metastatic breast cancer patient blood samples for downstream analysis. 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 Jul 1, 2019 Luminex Submits MRSA Assay for FDA Clearance Load More Breaking News Pediatric Medulloblastoma Subgroups May Benefit from Lower-Dose Radiation Therapy Space Radiation Shows Limited Effects on Mammalian Sperm DNA, Fertility Bluestar Genomics Sues Former Consultant, Ludwig Institute for Cancer Research Over IP Ownership New Products Posted to GenomeWeb: 10x Genomics, Swift Biosciences, Agilent Technologies, More In Brief This Week: Quantum-Si, TGen, Yale, and More People in the News: New Appointments at Invitae, PGDx, Oxford Nanopore, PacBio, More The Scan Fertility Fraud Found Consumer genetic testing has uncovered cases of fertility fraud that are leading to lawsuits, according to USA Today. Ties Between Vigorous Exercise, ALS in Genetically At-Risk People Regular strenuous exercise could contribute to motor neuron disease development among those already at genetic risk, Sky News reports. Test Warning The Guardian writes that the US regulators have warned against using a rapid COVID-19 test that is a key part of mass testing in the UK. Science Papers Examine Feedback Mechanism Affecting Xist, Continuous Health Monitoring for Precision Medicine In Science this week: analysis of cis confinement of the X-inactive specific transcript, and more.