FDA FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either self-collected or collected by a healthcare professional. DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test The laboratory-use QuantiVirus MPXV Test Kit targets two regions of the MPXV genome to detect the virus even if mutations occur in one target region. Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance The regulatory clearance of ACTOnco comes on the heels of Prenetics' acquisition of a majority stake of ACT Genomics last month. FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek FoundationOne Liquid CDx, a liquid biopsy test, is the only blood-based CDx approved for the targeted cancer therapy. Becton Dickinson Monkeypox PCR Assay Granted FDA Emergency Use Authorization The PCR test is designed to qualitatively detect monkeypox virus DNA in human lesion swab samples from patients suspected of monkeypox infection. Dec 28, 2022 Visby Medical Nabs FDA EUA for POC Respiratory Panel Test Dec 27, 2022 President Biden Signs Spending Bill, Boosting NIH, CDC, and FDA Budgets Dec 22, 2022 FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test Dec 21, 2022 FDA Approves Foundation Medicine Assay as CDx for Certain NSCLC Therapies Dec 19, 2022 FDA Updates Xeloda Labeling to Make DPYD Variant Risks More Explicit Dec 14, 2022 Thermo Fisher Scientific Receives FDA Emergency Use Authorization for Monkeypox PCR Assay Dec 13, 2022 Agilent, Qiagen Nab FDA Approvals for Lung Cancer Treatment CDx Dec 7, 2022 FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy Nov 22, 2022 FDA Grants Emergency Use Authorization for Premier Medical At-Home COVID Assay Nov 17, 2022 Biomarker Predicts Immunotherapy Benefit in Head and Neck Cancer but Commercial Path Unclear Premium Nov 15, 2022 Roche Receives FDA Emergency Use Authorization for Cobas Monkeypox Test Nov 14, 2022 PerkinElmer Nabs Authorization for Molecular SCID/SMA Test in Newborns Nov 10, 2022 FDA Grants Emergency Use Authorization for Nanobiosym PCR COVID-19 Test Nov 9, 2022 DiaSorin Gets FDA 510(k) Clearance for Molecular CMV Test Nov 9, 2022 FDA Grants Emergency Use Authorization for Rize Laboratory qPCR COVID-19 Test Nov 3, 2022 FDA Clears Grifols AAT Deficiency Test, OraSure Saliva Collection Device for Over-the-Counter Use Oct 24, 2022 Invivoscribe Files FDA Supplemental PMA for CDx Test to Select AML Patients for Daiichi Sankyo Drug Oct 24, 2022 Roche Obtains FDA 510(k) Clearance for COVID-19 PCR Test Oct 14, 2022 Clinical Decision Support Guidance Suggests FDA Will Regulate Risk Scores, Treatment Recommendations Premium Oct 7, 2022 Abbott Gets FDA Emergency Use Authorization for Monkeypox PCR Test Load More Breaking News New Products Posted to GenomeWeb: Qiagen, Thermo Fisher, Bionano Genomics, BillionToOne, More People in the News at Illumina Ventures, Element Biosciences, Epigenomics, Exagen, More Genomic Approaches Boost Rare Disease Diagnoses in Middle Eastern Patient Population GeneDx to Raise $150M in Public and Direct Stock Offerings In Brief This Week: T2 Biosystems, Novacyt, OpGen, Dante Genomics, Nautilus Biotechnology, More The Scan Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups. Genome-Wide Analysis Sheds Light on Genetics of ADHD A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder. MicroRNA Cotargeting Linked to Lupus A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus. Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.