Thermo Fisher Scientific (MA, USA), WuXi Diagnostics (Shanghai, China) and Mayo Clinic (MN, USA) are collaborating to develop a serology test for COVID-19. The test, which will receive clinical support and evaluation from Mayo Clinic, is expected to complement Thermo Fisher Scientific’s TaqPath molecular diagnostic test for COVID-19.
The serology test jointly developed as a result of the collaboration between the three companies will detect immunoglobulin M and immunoglobulin G in patient serology samples, to determine whether or not an individual has been exposed to SARS-CoV-2, the virus responsible for the COVID-19 pandemic.
The new OmniPath COVID-19 total antibody ELISA serology test will be designed to run on an open instrument platform. The test will act as a tool to assess an individuals’ antibody status and facilitate diagnosis during the acute and recovery phases of infection.
Manufacturing of the serology test is soon to begin at sites in the USA and Europe and Thermo Fisher Scientific are expected to seek emergency use authorization from the US FDA and international regulatory authorization in the coming weeks.
Marc Casper (Chairman, President and CEO of Thermo Fisher Scientific) commented: “Since the outbreak was first detected, we have mobilized our scientific, regulatory and commercial teams to support virus analysis, identification, deployment of personal protective equipment as well as development of therapies and vaccines. Stopping the spread of COVID-19 requires comprehensive testing solutions and we are very pleased to join forces with WuXi Diagnostics and Mayo Clinic to respond to the widespread need for antibody-based tests. Working together, we will now be able to provide governments, healthcare systems and communities with yet another important tool to aid in the fight against the pandemic.”
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Jason Liu (CEO of WuXi Diagnostics) explained: “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 for COVID-19. WuXi Diagnostics offers an open-access platform for innovative diagnostic solutions. By collaborating with our partners, we’re dedicated to supporting healthcare professionals and their patients around the world.”
Gianrico Farrugia (President and CEO of Mayo Clinic) added: “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.”