Seasun Biomaterials Secures FDA Emergency Use Authorization for Second COVID-19 Rapid Detection Kit
Seasun Biomaterials, Inc. (Daejeon, Korea) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its second COVID-19 assay AQ-TOP COVID-19 Rapid Detection Kit following the completion of FDA EUA (April-27) of its U-TOP COVID-19 Real-Time Detection Kit. More...25 May 2020
New Mount Sinai Venture to Manufacture and Distribute COVID Antibody Test Kits Globally
Mount Sinai Health System (New York, NY, USA), along with Renalytix AI (New York, NY, USA), has formed a new venture named Kantaro Biosciences, LLC to develop and scale production and distribution of its SARS-CoV-2 antibody test. More...23 May 2020
Abbott Wins UK Government Contract to Supply Millions of Laboratory-Based IgG Antibody Tests
Abbott (Lake Forest, IL, USA) has been awarded a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the UK over the coming months. More...23 May 2020
GSK and Mammoth Biosciences to Jointly Develop Handheld, Disposable and Rapid CRISPR-based Test for COVID-19
GSK Consumer Healthcare (Brentford, UK) and Mammoth Biosciences (San Francisco, CA, USA) have entered into a collaboration to develop a fully disposable, rapid and handheld COVID-19 test using a CRISPR-based platform. More...21 May 2020
Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV-2 IgG Antibody
Enzo Biochem (New York, NY, USA) has launched a SARS-CoV-2 IgG ELISA assay kit for serological detection of IgG antibodies against the novel coronavirus under the FDA’s Emergency Use Authorization (EUA) authority as both products and services. More...21 May 2020
In Other News
Thermo Fisher to Distribute Chembio’s DPP COVID-19 System in US
Quidel Granted FDA EUA for Lyra Direct SARS-CoV-2 Assay to Allow Direct Sample Processing
Ortho's COVID-19 IgG Antibody Test Receives CE Mark
DxGen Launches '2 Minutes' COVID-19 Antibody Testing System
Bio-Rad’s CFX96 Dx Real-Time PCR System Listed with FDA for IVD Testing
Technopath Launches Multichem ID-COVID-19 Quality Control Solutions
New COVID-19 Antibody Test Platform Combines Antibody Testing and Blockchain Technology
New COVID-19 Mouth Swab Test Can Be Completed On-Premises in 13-25 Minutes Without Laboratory Involvement
Higher Concentrations of COVID-19 Receptor Protein Found in Men’s Plasma
World’s First SARS-CoV-2 Serology Test Detects Neutralizing Antibodies Without Containment Facility or Specimen
Hologic’s Second Molecular Test for COVID-19 Granted FDA Emergency Use Authorization
FDA Requires Real Patient Samples for Emergency Use Authorization of COVID-19 MDx Tests
Thermo Fisher Partners with Wuxi Diagnostics and Mayo Clinic for Developing New COVID-19 Serology Test
Applied DNA Receives FDA Emergency Use Authorization for COVID-19 Diagnostic Assay Kit
EKF and Tosoh Europe N.V. Sign Distribution Agreement for Quo-Test HbA1c POC Analyzer in Middle East and Africa
1drop's 1copy COVID-19 qPCR Multi Kit Granted Emergency Use Authorization by FDA
Ortho Clinical and Quest Diagnostics to Broaden Availability of COVID-19 Antibody Testing
Thermo Fisher SARS‑CoV‑2 Multiplex Real-Time PCR Test Granted Expanded EUA by FDA
New One Minute Coronavirus Test Offers More than 90% Accuracy at Dramatically Lower Price
Ortho COVID-19 Total Antibody Test Receives CE Mark
Abbott Granted FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity m System
Abbott COVID-19 Antibody Blood Test on Alinity i System Granted FDA Emergency Use Authorization
Abbott's SARS-CoV-2 Antibody Blood Test Demonstrates High Performance in Validation Study