FDA submission GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test The test recently received a CPT PLA code and is currently offered through GenInCode's laboratory in Irvine, California. Guardant Health Pushing Hard to Contextualize CRC Screening Data as Core Business Chugs Along Premium The company is seeing continuing growth for its existing clinical products as it moves resources toward commercialization of its Guardant Shield CRC screening test. Cue Health Submits At-Home Molecular RSV Assay to FDA The de novo submission is for a molecular diagnostic test for respiratory syncytial virus meant for home and point-of-care use. OpGen Seeking FDA Marketing Authorization for Urinary Tract Infection Panel The FDA submission follows completion of a clinical trial showing the highly multiplexed PCR assay had 96.8 percent sensitivity and 97.4 percent specificity. Guardant Health Submits Colorectal Cancer Screening Test to FDA for Premarket Approval The firm's application is supported by data from the ECLIPSE study, which compared results of the Shield test to colonoscopy findings in 20,000 individuals. Jan 24, 2023 Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test Dec 16, 2022 Guardant Health CRC Screening Results Spook Investors Despite Meeting Reimbursement Requirements May 2, 2022 Cue Health Files for Full FDA Clearance of COVID-19 Molecular Test Dec 15, 2021 Enzo Biochem Q1 2022 Revenues Down 8 Percent Nov 16, 2021 Geneoscopy Closes $105M Series B Financing Round Nov 8, 2021 German MDx Firm Mainz Biomed Raises $10M in IPO, Begins Trading on Nasdaq Aug 17, 2021 Tempus Submits PMA Application for Tumor Profiling Assay to FDA Apr 20, 2021 Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer Apr 2, 2021 Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib Nov 24, 2020 Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform Premium Nov 11, 2020 Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test Premium Sep 28, 2020 Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer Sep 25, 2020 NIH Awardee MatMaCorp Developing SARS-CoV-2 Molecular Test for Rural Hospitals Premium Sep 23, 2020 Becton Dickinson Submits Premarket Approval Supplement to FDA for HPV Assay Aug 7, 2020 Illumina Sees Expanding Sequencing Market in COVID-19 Response, Despite Short-Term Woes Premium Jul 20, 2020 Sepset Biosciences Leveraging COVID-19 Patient Samples in Study to Validate Sepsis Test Premium Jun 16, 2020 Immunexpress Nabs $599K BARDA Contract to Develop Sepsis Test for Coronavirus Patient Triage Jun 8, 2020 QuantuMDx Receives CE-IVD Marking for SARS-CoV-2 Test May 29, 2020 Fry Laboratories Plans COVID-19 NGS Diagnostic Kit Offering Premium May 13, 2020 Adaptive Eyes NGS-Based Test for T Cell Response in COVID-19 Premium Load More Breaking News SARS-CoV-2 Mutational Signature Associated With Mutagenic Antiviral Drug Biocartis Restructures Balance Sheet as H1 2023 Revenues Rise 12 Percent Rare Kidney Cancer Genomic Analysis Reveals Potential Target, Suggests Treatment SEC Concludes CareDx Investigation, Recommends No Enforcement Action Streck Quality Controls for DiaSorin's Luminex Sepsis Tests Receive FDA Clearance 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.