regulatory approval Castle Biosciences Gains New York State Approval for Pittsburgh Laboratory The company can now serve NY state patients from either of its two facilities, in addition to populations across other US states under its existing CLIA certifications. Guardant Health Receives Guardant360 CDx Regulatory Approval in Japan for HER2 Lung Cancer Treatment Patients who test positive for a HER2 mutation and have seen their disease progress after chemotherapy can now be treated with Daiichi Sankyo's Enhertu. Amoy Diagnostics PLC Panel Gets Approval in Japan as CDx for Retevmo in Non-Small Cell Lung Cancer Oncologists in Japan can now use the AmoyDx Pan Lung Cancer PCR Panel to identify patients with RET fusions that make them eligible for treatment with the Eli Lilly drug. 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. Dec 7, 2022 FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy Aug 22, 2022 Pillar Biosciences Receives China Approval for Colon Cancer Companion Diagnostic Assay Aug 5, 2022 Guardant Health Shares Details on MRD Reimbursement, Early Detection Trial Premium 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 Load More Breaking News Genetic Contributors to Plasma Protein Levels Unearthed in Multiple Studies Standard BioTools, SomaLogic to Merge Arima Genomics, Protean BioDiagnostics Launch 3D Genomics Cancer Testing Joint Venture Pathnostics UTI Test Nabs New York State Approval NanoString, A*Star, Next Level Genomics to Launch Spatial Biology Laboratory in Singapore 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.