nucleic acid amplification FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test The nucleic acid amplification test is the first at-home, over-the-counter test for COVID-19 to be granted marketing authorization using the traditional premarket review pathway. Lucira Health Receives Health Canada Authorization for At-Home COVID-19, Flu Test The nucleic acid amplification test for COVID-19 and influenza A/B delivers results in 30 minutes from a shallow nasal swab. Lucira Health Nabs CE Mark for COVID-19, COVID/Flu Molecular Tests The company plans to make its combination COVID-19 and influenza test available in the EU in the third quarter of 2022. Cue Health Lays Out Road Map for Menu Expansion, Targets DTC Market in 2022 Premium The molecular diagnostic firm has also begun international commercialization of its products in Canada and Singapore. Sense Biodetection, Cruinn Diagnostics Ink Distribution Deal for COVID-19 Test in Ireland The single-use molecular test, which received CE marking last week, requires no instrument and returns results in 15 minutes. Dec 15, 2021 LumiraDx Inks Deal with Audere for At-Home COVID-19 Test Collection Kit Nov 10, 2021 Cue Health Revenues up Massively in Q3 Jul 9, 2021 WHO Updates Recommendations to Improve Access to Rapid MDx Tests for TB, Drug-Resistant TB Feb 18, 2021 WHO Finds High Diagnostic Accuracy in Three Classes of MDx Technologies for TB Testing, Resistance Feb 11, 2021 Cue Health Ramping Up COVID-19 Test Production Following Positive Mayo Clinic Study, DoD Funding Premium Jan 12, 2021 JumpCode Genomics Raises $21M in Series B Financing Round Nov 24, 2020 Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform Premium Jan 31, 2020 NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked Jan 23, 2020 Startup BioSkryb Eyes Oncology Applications for Single-Cell DNA Sequencing Premium Jan 22, 2020 Sysmex Wins Chinese Approval for Breast Cancer IVD Reagent Jan 8, 2020 BioSkryb Raises $11.5M in Seed Funding Jan 6, 2020 NuProbe Global, CarrierGene Biotech Complete Merger, Partner With Illumina Oct 2, 2019 Geneoscopy Raises $6.9M in Series A Financing Jul 11, 2019 Enzo Biochem Gets NY Approval for Oral, Rectal CT/NG Test; Updates Lab Business Models Feb 21, 2019 SAW Diagnostics Developing Acoustic Sample Prep Technology for Point-of-Care MDx Premium Feb 14, 2019 Geneoscopy Develops Colorectal Cancer Dx Using RNA Biomarkers, Taking Aim at Exact Sciences Premium Feb 14, 2019 Hologic Aptima HIV-1 Assay Receives Dual Claim CE Marking Jan 23, 2019 Hologic M. Genitalium Assay Gets FDA De Novo Clearance Nov 26, 2018 Group B Strep Test From DiaSorin Molecular Cleared by FDA Aug 2, 2018 FDA Clears Hologic Panther Fusion GBS Assay 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.