regulatory approval 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. FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy The marketing authorization makes Thermo Fisher’s SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic. Pillar Biosciences Receives China Approval for Colon Cancer Companion Diagnostic Assay The OncoReveal Dx Colon Cancer Assay is intended for use on the Illumina MiSeq Dx, and now has approvals in China, the US, and Europe. Guardant Health Shares Details on MRD Reimbursement, Early Detection Trial Premium The company achieved two major milestones this year with the launch of its Guardant Shield test and Medicare reimbursement for its Guardant Reveal test. Jul 20, 2022 Molecular Health Gains EU IVDR Certification for Clinical Decision Support Software Jun 14, 2022 Sophia Genetics Gets CE-IVD Mark for DDM Platform's Analytics May 10, 2022 Hologic Nabs FDA Approval for Quantitative Cytomegalovirus Test Apr 19, 2022 New York State Approves Enzo Biochem HPV Molecular Test Mar 15, 2022 Burning Rock Secures Lung Cancer NGS Test Regulatory Approval in China Feb 8, 2022 Binx Health Nabs Canadian Approval for COVID-19 Sample Kits, Contracts With North Carolina, Maryland Nov 18, 2021 Precipio Hematologic Malignancy Test Receives NY State Approval Aug 5, 2021 Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay Jun 23, 2021 Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus Apr 1, 2021 Guardant Health Receives New York State Approval for Guardant Reveal MRD Test Mar 31, 2021 Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial Mar 30, 2021 Binx Health Chlamydia and Gonorrhea Test CLIA Waived Mar 5, 2021 Illumina Receives Medical Device Registration in Russia for NextSeq 550 Dx Sequencer, Reagents Mar 1, 2021 OpGen Unyvero IVD Platform Nabs Chinese Regulatory Approval Feb 25, 2021 Adaptive Biotechnologies Touts New Era of T Cell-Based Dx With T-Detect COVID Launch Premium Jan 19, 2021 MiRxes Receives CE Mark, Singapore Regulatory Approval for Multiplex SARS-CoV-2, Flu Test Dec 2, 2020 China NMPA Approves Illumina NextSeq 550Dx Sequencer for Genetic Testing and Diagnosis Nov 13, 2020 FDA Approves Merck's Keytruda, Agilent CDx in PD-L1-High Triple-Negative Breast Cancer Nov 11, 2020 OpGen Posts 70 Percent Increase in Q3 Revenues Amid Shuffling of Portfolio Nov 9, 2020 FDA Approves Foundation Medicine Liquid Biopsy Test as CDx for Lynparza 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.