CLIA BioMérieux Submits Dual FDA Marketing, CLIA Waiver Application for Respiratory, Sore Throat Panel The French diagnostics maker is seeking both 510(k) clearance and a CLIA waiver for the multiplex PCR test, which can be used at the point of care. Thermo Fisher Scientific to Promote Devyser Laboratory Services for Pharma Research The companies will work together to market Devyser Diagnostics' CLIA-certified lab services to pharmaceutical companies for research and development projects. At FDA and in Utah, Transparency Projects Probing Lab Test Quality in Cancer Care Premium The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk. BioMérieux Gets CLIA Waiver for BioFire SpotFire Respiratory Panel Mini The CLIA waiver now allows the SpotFire system and two existing panels to be used by non-lab professionals at the point of care, the firm said. Devyser Gets CLIA Certification for Atlanta Lab The Sweden-based firm said it will use the laboratory to perform testing for hereditary diseases, oncology, post-transplant monitoring, and other patient management. Feb 8, 2023 BioMérieux Point-of-Care System, Respiratory Panel Get FDA 510(k) Clearance, CLIA Waiver Nov 15, 2022 Eremid Genomic Services Receives CLIA Accreditation for New Lab Oct 11, 2022 South Korean Proteomics Firm Bertis Opening CLIA Lab in San Diego by End of Year Premium Oct 4, 2022 Nonprofit's Efforts With Payors to Assess NGS Labs' Variant Interpretations Spark Debate Premium Sep 23, 2022 Bionano Genomics Launches CLIA-Certified Laboratory, First OGM-Based Test Jun 6, 2022 Bluestar Genomics Gets CLIA Certification Apr 27, 2022 Neogen Obtains CLIA Certification for Genomics Lab Feb 22, 2022 Genetic Technologies Lab Gets Regulatory Approvals in US, Australia Jan 6, 2022 Pillar Biosciences Gets CLIA Certification for Sequencing Clinical Lab Nov 30, 2021 Akoya Receives CLIA Certification for Biopharma Solutions Laboratory May 18, 2021 TruDiagnostic Receives CLIA Certification for Kentucky Laboratory May 11, 2021 Applied DNA Sciences Subsidiary Gets CLIA Certification From NY State Department of Health Mar 30, 2021 Binx Health Chlamydia and Gonorrhea Test CLIA Waived Dec 10, 2020 Lucence Obtains CLIA Certification for Palo Alto Lab Dec 9, 2020 Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test Nov 11, 2020 Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test Premium Aug 17, 2020 Fulgent Genetics Opens CLIA-Certified Lab in Houston, Raises Revenue Guidance Jan 29, 2020 IDbyDNA Raises $20M in Series B Financing Oct 14, 2019 Avellino Labs Gets CLIA Certification Jun 26, 2019 Oncocyte Shares Tank on News of Delayed CLIA Validation Study for Liquid Biopsy Lung Cancer Test 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.