Thermo Fisher Enlists WuXi and Mayo Clinic for New Serology Test

Thermo Fisher Scientific is continuing to move fast and furious with its COVID-19 detection efforts. The firm is now collaborating with WuXi Diagnostics and Mayo Clinic to develop a new serology test in response to the COVID-19 pandemic. Plans call for Waltham, MA-based Thermo Fisher to seek FDA Emergency Use Authorization (EUA) and international regulatory authorizations for the OmniPath COVID-19 Total Antibody Elisa test in the coming weeks. Thermo Fisher said once approved for use, the OmniPath COVID-19 Total Antibody ELISA test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. Gianrico Farrugia, MD, CEO and President of Mayo Clinic, said in a release that, "rapidly expanding access to high-quality testing requires bold collaborations across the laboratory industry. This marks a significant milestone in our national testing response to COVID-19 and was made possible by bringing together the commercialization capabilities of Thermo Fisher Scientific, testing development abilities of WuXi Diagnostics, and clinical and laboratory expertise of Mayo Clinic physicians and scientists." Jason Liu, PhD, CEO of WuXi Diagnostics, said in a release, "We are pleased to join forces with Thermo Fisher and Mayo Clinic in the battle against the pandemic. This global collaboration of R&D, clinical expertise, manufacturing, and commercialization capability will significantly advance serological testing ...
Source: MDDI - Category: Medical Devices Authors: Tags: COVID-19 IVD Source Type: news