PMA FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders. BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx The expanded test can be used for genotype risk-based patient monitoring to prevent over-treatment, BD has said. Invivoscribe Receives Supplemental Approval for AML Kit The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing. GSK Gets Broad Zejula Indication in Ovarian Cancer; FDA Deems Myriad Genetics' Test Complementary The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit. Caris Life Sciences Seeks FDA Approval for Exome, Transcriptome CDx Assays The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity. Apr 1, 2020 FDA Proposes Reclassification of HCV RNA, Antibody Tests Feb 11, 2020 Myriad Files sPMA With FDA for Test to ID Best Responders to Lynparza, Avastin Combination Jan 23, 2020 Myriad Genetics Seeks Supplemental Approval of HRD Test as CDx for GSK Ovarian Cancer Drug Nov 12, 2019 Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval Aug 7, 2019 Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx Apr 9, 2019 Myriad Submits MyChoice HRD as Companion Diagnostic for GSK's Zejula Oct 16, 2018 FDA Approves Myriad Genetics BRCA CDx With Pfizer's Metastatic Breast Cancer Drug Jun 18, 2018 Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx Apr 19, 2018 FDA Expands Approval of Roche Cobas Test as CDx for EGFR Deletions, Mutations Jan 25, 2018 FDA Grants Approval for Hologic Hepatitis B Viral Load Assay Oct 18, 2017 FDA Accepts Myriad BRACAnalysis CDx Supplementary PMA for Lynparza in Breast Cancer Indication Aug 1, 2017 Abbott Receives FDA Approval for IDH2 Mutation CDx Alongside AML Drug Jun 22, 2017 Thermo Fisher Next-Gen Sequencing Panel Wins FDA Approval as Companion Test Mar 20, 2017 Siemens Healthineers Gets FDA Premarket Approval for HCV Genotyping Test Feb 16, 2017 Hologic HCV Assay Wins FDA Premarket Approval Nov 14, 2016 Thermo Fisher Submits Premarket Approval Application to FDA for Sequencing-Based Companion Dx Nov 2, 2016 Myriad Moving Ahead With PMA Filing for MyChoice HRD as Companion Test for Niraparib Premium Dec 4, 2015 In Brief This Week: Pacific Biosciences; Epigenomics; Cynvenio Biosystems; and More Jul 30, 2015 Roche Files PMA for Updated Cobas EGFR Test as CDx for AstraZeneca's AZD9291 Jun 15, 2015 Ventana ALK IHC Test Gets FDA Approval as CDx for Pfizer's Xalkori Load More Breaking News Roche Receives EUA for PCR-Based, Point-of-Care SARS-CoV-2 Test Decode Study Identifies Proteomic Predictors of All-Cause Mortality In Brief This Week: Natera, Bruker, Bayer, and More New Products Posted to GenomeWeb: Labcorp, Omniseq, Dovetail Genomics, DNA Script, More People in the News: New Appointments at Sema4, Strata Oncology, Bionano Genomics, More Co-Diagnostics Gets CE Mark for Saliva-Based Molecular SARS-CoV-2 Test The Scan Billions for Antivirals The US is putting $3.2 billion toward a program to develop antivirals to treat COVID-19 in its early stages, the Wall Street Journal reports. NFT of the Web Tim Berners-Lee, who developed the World Wide Web, is auctioning its original source code as a non-fungible token, Reuters reports. 23andMe on the Nasdaq 23andMe's shares rose more than 20 percent following its merger with a special purpose acquisition company, as GenomeWeb has reported. Science Papers Present GWAS of Brain Structure, System for Controlled Gene Transfer In Science this week: genome-wide association study ties variants to white matter stricture in the brain, and more.