Thermo Fisher Partners with Wuxi Diagnostics and Mayo Clinic for Developing New COVID-19 Serology Test

(Waltham, MA, USA) will be developing a total antibodies test in collaboration with Wuxi Diagnostics (Shanghai, China) and Mayo Clinic (Rochester, NY, USA).

The new Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test is the result of ongoing collaboration between the three organizations, including clinical evaluation and support from Mayo Clinic. Thermo Fisher will seek US FDA Emergency Use Authorization (EUA) and international regulatory authorizations for the test over the next few weeks. Once approved for use, the test will detect Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to help clinicians determine if a patient has been exposed to SARS-CoV-2. The test is designed to run on an open instrument platform, and the determination of antibody status will aid in the diagnosis of the disease during the acute and recovery stages of infection. Thermo Fisher will begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the US and Europe in the next few weeks as it prepares to submit for EUA.

“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,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. “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.”

“We are pleased to join forces with Thermo Fisher and Mayo Clinic in the battle against the pandemic,” said Jason Liu, Ph.D., chief executive officer of WuXi Diagnostics. “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.”

“Rapidly expanding access to high-quality testing requires bold collaborations across the laboratory industry,” said Gianrico Farrugia, M.D., chief executive officer and president of Mayo Clinic. “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.”