emergency use authorization LumiraDx Secures FDA Emergency Use Authorization, UK Approval for COVID-19, Flu Test The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete test is a laboratory-use assay run on open RT-PCR instruments. FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either self-collected or collected by a healthcare professional. DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test The laboratory-use QuantiVirus MPXV Test Kit targets two regions of the MPXV genome to detect the virus even if mutations occur in one target region. Aided by COVID-19 Funding, Firms Continued Developing Handheld Diagnostic Instruments in 2022 Premium The lightweight, portable instruments coming onto the market employ promise to deliver test results closer to patients, potentially hastening treatments. Becton Dickinson Monkeypox PCR Assay Granted FDA Emergency Use Authorization The PCR test is designed to qualitatively detect monkeypox virus DNA in human lesion swab samples from patients suspected of monkeypox infection. Dec 28, 2022 Visby Medical Nabs FDA EUA for POC Respiratory Panel Test Dec 22, 2022 FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test Dec 14, 2022 Thermo Fisher Scientific Receives FDA Emergency Use Authorization for Monkeypox PCR Assay Nov 22, 2022 Lucira Health Molecular COVID/Flu Test Gets FDA Emergency Use Authorization Nov 22, 2022 FDA Grants Emergency Use Authorization for Premier Medical At-Home COVID Assay Nov 15, 2022 Roche Receives FDA Emergency Use Authorization for Cobas Monkeypox Test Nov 10, 2022 FDA Grants Emergency Use Authorization for Nanobiosym PCR COVID-19 Test Nov 9, 2022 FDA Grants Emergency Use Authorization for Rize Laboratory qPCR COVID-19 Test Oct 19, 2022 Aptitude Medical Gets FDA EUA for Over-the-Counter COVID Saliva MDx Oct 7, 2022 Abbott Gets FDA Emergency Use Authorization for Monkeypox PCR Test Oct 5, 2022 FDA Advises Monkeypox Test Developers to Pick Multiple Targets Sep 22, 2022 FDA Allowed Problematic COVID-19 Tests on the Market Due to Agency's EUA Approach, HHS OIG Finds Sep 21, 2022 FDA Urges Work on Monkeypox Assays, Including OTC MDx Tests Sep 7, 2022 HHS Authorizes FDA to Issue EUAs for Monkeypox Tests, Quest Diagnostics Gets First Authorization Aug 3, 2022 Helix Diagnostics SARS-CoV-2 Test Nabs FDA EUA for Serial Testing Jul 29, 2022 FDA Reissues EUA for Meridian Bioscience COVID-19 Test After Omicron Variant Trouble Jul 22, 2022 FDA Grants Emergency Use Authorization for Predicine COVID-19 Test Jun 15, 2022 Roche Quantitative, Qualitative SARS-CoV-2 Test Gets FDA Emergency Use Authorization Jun 7, 2022 DxLab Receives FDA Emergency Use Authorization For RT-LAMP COVID-19 Test May 20, 2022 FDA Grants EUAs for Labcorp Respiratory Panel, Nexus Medical COVID-19 Test Load More Breaking News Simple HealthKit Raises $8M in Series A Round Top Five Articles on GenomeWeb Last Week: Quantum-Si Layoffs, UBS Coverage Initiations, More LumiraDx Secures FDA Emergency Use Authorization, UK Approval for COVID-19, Flu Test Rarity Bioscience Raises Additional €500,000 Cancer Prognoses Informed by Module-Based Approach, Study Finds The Scan UK Team Presents Genetic, Epigenetic Sequencing Method Using enzymatic DNA preparation steps, researchers in Nature Biotechnology develop a strategy for sequencing DNA, along with 5-methylcytosine and 5-hydroxymethylcytosine, on existing sequencers. DNA Biobank Developed for French Kidney Donors, Recipients The KiT-GENIE biobank described in the European Journal of Human Genetics contains DNA samples, genotyping profiles, immune patterns, and clinical features for thousands of kidney donors or transplant recipients in Nantes, France. Cardiometabolic Disease May Have Distinct Associations With Microbial Metabolites in Blood, Gut By analyzing gut microbes in combination with related metabolites in feces and blood, researchers in Nature Communications found distinct cardiometabolic disease relationships at each site. Study Reveals New Details About Genetics of Major Cause of Female Infertility Researchers in Nature Medicine conducted a whole-exome sequencing study of mote than a thousand patients with premature ovarian insufficiency.