New Purpose-Built COVID-19 LIMS Solution Jump-Starts COVID-19 Testing and Research
A new purpose-built COVID-19 laboratory information management system (LIMS) solution can jump-start the ability of laboratories everywhere to enter biospecimens into a biobank and rapidly begin conducting COVID-19-related testing and research. More...11 May 2020
Quidel’s Sofia 2 SARS Antigen FIA Becomes First COVID-19 Antigen Test to Secure FDA Emergency Use Authorization
Quidel Corporation’s (San Diego, CA, USA) Sofia 2 SARS Antigen FIA has become the first COVID-19 antigen test to be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). More...11 May 2020
Johns Hopkins Launches New COVID-19 Testing Insights Initiative
Johns Hopkins University (Baltimore, MD, USA) has launched the COVID-19 Testing Insights Initiative, a one-stop resource hub that fills the void of publicly-available information about COVID-19 testing data and offers critical insights, resources, and expert analysis about COVID-19 testing in the US. More...09 May 2020
BioMérieux Announces Upcoming Launch of VIDAS Anti-SARS-CoV-2 Serology Tests
BioMérieux (Marcy-l'Étoile, France) has announced performance validation and the upcoming launch of VIDAS anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to the SARS-CoV-2 that causes the COVID-19 disease. More...09 May 2020
Gilead’s Remdesivir Granted Regulatory Approval in Japan for Patients with Severe COVID-19
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval to Veklury (remdesivir) as treatment for SARS-CoV-2 infection under an exceptional approval pathway. More...09 May 2020
IDEXX-Made OPTI SARS-CoV-2 RNA PCR Test Kit Secures FDA Emergency Use Authorization
IDEXX Laboratories, Inc.’s (Westbrook, ME, USA) subsidiary, OPTI Medical Systems, Inc. (Roswell, GA, USA), has been granted Emergency Use Authorization (EUA) by the US FDA for its OPTI SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2. More...08 May 2020
Sherlock CRISPR SARS-CoV-2 Kit Becomes First FDA-Authorized Use of CRISPR Technology for COVID-19
Sherlock Biosciences (Cambridge, MA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Sherlock CRISPR SARS-CoV-2 kit for the detection of the virus that causes COVID-19, providing results in approximately one hour. More...08 May 2020
In Other News
Biomerica Receives CE Mark for New High-Volume Production Version of COVID-19 IgG/IgM Rapid Test
Hardy Diagnostics’ COVID-19 Antibody Test Granted FDA Emergency Use Authorization
Eurofins Launches CE-IVD Marked Multiplex Real-Time PCR Assay for SARS-CoV-2 Detection
Siemens' Fast Track Diagnostics SARS-CoV-2 Test Granted FDA Emergency Use Authorization
FDA’s Revised Policy Tightens Requirements for COVID-19 Antibody Tests
PerkinElmer Secures FDA Emergency Use Authorization for EUROIMMUN’s Anti-SARS-CoV-2 ELISA Serology Test
Antibody Detection Is Critical for COVID-19 Diagnosis
PlexBio Receives CE Mark for PCR-based Coronavirus Detection Kit
BioMérieux's BioFire SARS-CoV-2 Respiratory Panel Obtains FDA Emergency Use Authorization
Bio-Rad ddPCR COVID-19 Assay Secures FDA Emergency Use Authorization
Roche’s COVID-19 Antibody Test Receives FDA Emergency Use Authorization
Quotient Limited Receives CE Mark for Its SARS-CoV-2 (COVID-19) Antibody Microarray
Hologic Launches Second High-Throughput Molecular Assay for Novel Coronavirus
Avacta and Adeptrix Collaborate to Develop Coronavirus Antigen Test Using Mass Spectrometry
Bio-Rad’s SARS-CoV-2 Serology Test Becomes First Total COVID Antibody Test to Secure FDA EUA
Aalto Bio Launches Lysis Buffer Reagent for COVID-19 Testing
Altona Diagnostics Receives Emergency Use Authorization from US FDA for RealStar SARS-CoV-2 RT-PCR Kit US
NIH’s RADx Initiative to Speed Development of Rapid and Widely Accessible COVID-19 Testing
BillionToOne COVID-19 Test with 30X Higher Throughput Could Unlock Millions of Daily Testing Capacity Worldwide
Study of COVID-19 POC Tests Finds Antibody Tests Can Complement PCR Diagnostics
Rheonix Receives FDA Emergency Use Authorization for Rapid, Fully Automated Molecular COVID-19 Test
SEASUN BIOMATERIALS Launches COVID-19 Rapid Molecular Assay
Harvard-Designed Injection-Molded Nasopharyngeal Swabs For COVID-19 Enter Human Trials