PMA Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test The application is supported by data from the company's prospective trial, demonstrating 94 percent sensitivity for CRC in an average-risk cohort. 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. Apr 28, 2020 Caris Life Sciences Seeks FDA Approval for Exome, Transcriptome CDx Assays 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 Load More Breaking News SARS-CoV-2 Variants of Concerns Evolved to Modify Host Immune Response, Multiomics Study Shows People in the News at GA4GH, Mercy BioAnalytics, Deepcell, One Biosciences New Products Posted to GenomeWeb: Clinical Microbiomics, Integra Biosciences, DNAstack, Bruker Angolan Namib Desert Population Analysis Uncovers New Ancestry Group With Deep Divergence Cedars-Sinai Sets Up $25M Single Cell Precision Medicine Center The Scan Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants. Small Study of Gene Editing to Treat Sickle Cell Disease In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms. Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema. Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.