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2022-05-07 04:09:55

Skip to main content Sister Publication Links GenomeWeb 360Dx Precision Oncology News RSS Feeds Visit 360Dx on Twitter Visit 360Dx on LinkedIn Premium Trial: Request an Annual Quote User account menu My 360Dx Profile Newsletters My Topics Reading List Log out Log in Subscribe Menu Close Menu Main navigation My 360Dx Profile Newsletters My Topics Reading List Log out Business & Policy Business News Research Funding Policy & Legislation Regulatory News Reimbursement Clinical Lab Management Diagnostics Molecular Diagnostics Immunoassays Tissue-Based Testing Clinical Chemistry Hematology/Coagulation Point-of-Care Testing Companion Diagnostics Disease Areas Cancer Infectious Disease Cardiovascular Disease Neurological & Psychological Disease Autoimmune Disease Inherited Disease Reproductive Health Respiratory Gastrointestinal COVID-19 Resources Webinars White Papers Job Listings New Products People in the News Coronavirus Test Tracker Partner Content Premium Trial: Request an Annual Quote Log in Subscribe Post-EUA Regulatory Landscape for COVID-19 Tests Coming Into View, But Details Remain Fuzzy Premium A few firms have made de novo or 510(k) submissions, but many are waiting as they continue to assess the market for their tests and look to the FDA for further guidance. First FDA EUA for Breath-Based COVID Test in Hand, InspectIR Focusing on Commercialization Premium The company's breath test uses mass spectrometry to determine a user's response to the presence of SARS-CoV-2. Labs Worry End of HRSA Funding Could Impact Access to COVID-19 Testing for Uninsured Premium The federal program stopped reimbursing COVID-19 tests for uninsured individuals at the end of March due to lack of funds, leaving a potential gap in testing coverage. Dx Startup Detect Preparing to Roll Out Next-Gen Molecular Instrument, Broaden Test Menu Premium On the heels of itsCOVID-19 test, the firm is developing a multiplex test for flu/COVID-19 and targeting tests for Streptococcus and STIs. Adaptive Biotechnologies Making Inroads in MRD, Immune Medicine Businesses Premium The Seattle-based company recently completed a strategic reorganization around its two major business areas by cutting the workforce and appointing a new CFO. Veracyte Reports Progress Across Evolving Lung Test Portfolio Premium New publications have expanded the discussion around the Envisia lung disease test as the firm builds evidence for its recently launched lung cancer nasal swab assay. Business, Policy & Funding DiaSorin Q1 Revenues Rise 34 Percent Despite Dip in COVID-19 Test Demand Personalis Building Data for High-Sensitivity Residual Cancer Assay Premium In Brief This Week: FDA, Sema4, Veracyte, Trinity Biotech; Binx Health, More Tempus to Provide NGS Cancer Tests to US Department of Veterans Affairs Meridian Bioscience Fiscal Q2 Revenues Climb 30 Percent Diagnostics DiaSorin Q1 Revenues Rise 34 Percent Despite Dip in COVID-19 Test Demand Personalis Building Data for High-Sensitivity Residual Cancer Assay Premium Tempus to Provide NGS Cancer Tests to US Department of Veterans Affairs Meridian Bioscience Fiscal Q2 Revenues Climb 30 Percent Chembio Q1 Revenues More Than Double Disease Areas CareDx Q1 Revenues up 18 Percent Post-EUA Regulatory Landscape for COVID-19 Tests Coming Into View, But Details Remain Fuzzy Premium Adaptive Biotechnologies Making Inroads in MRD, Immune Medicine Businesses Premium Myriad Genetics Q1 Product Revenues Increase 3 Percent Qiagen Obtains CE Mark for Molecular HSV Test on NeuMoDx Platforms Clinical Lab Management Post-EUA Regulatory Landscape for COVID-19 Tests Coming Into View, But Details Remain Fuzzy Premium Labs Worry End of HRSA Funding Could Impact Access to COVID-19 Testing for Uninsured Premium Quest Diagnostics Survey Indicates Strong Interest Among Doctors for Blood-Based Alzheimer's Tests Labcorp Q1 Revenues Down 6 Percent Labs Concerned New Draft CDC Opioid Guidelines Downplay Role of Toxicology Testing Premium Breaking News DiaSorin Q1 Revenues Rise 34 Percent Despite Dip in COVID-19 Test Demand In Brief This Week: FDA, Sema4, Veracyte, Trinity Biotech; Binx Health, More Tempus to Provide NGS Cancer Tests to US Department of Veterans Affairs Meridian Bioscience Fiscal Q2 Revenues Climb 30 Percent Chembio Q1 Revenues More Than Double CareDx Q1 Revenues up 18 Percent What's Popular? Post-EUA Regulatory Landscape for COVID-19 Tests Coming Into View, But Details Remain Fuzzy Premium In Brief This Week: FDA, Sema4, Veracyte, Trinity Biotech; Binx Health, More Tempus to Provide NGS Cancer Tests to US Department of Veterans Affairs Guardant Health Q1 Revenues up 22 Percent Labs Worry End of HRSA Funding Could Impact Access to COVID-19 Testing for Uninsured Premium Sponsorships Footer About us Advertise Contact FAQ Jobs Sitemap Submit A Tip Subscribe Privacy Policy.  Terms & Conditions. Copyright © 2022 GenomeWeb, a business unit of Crain Communications.  All Rights Reserved.