Wuxi Diagnostics and the Mayo Clinic have joined Thermo Fisher in a three-way collaboration, as they prepare to submit their OmniPath COVID-19 antibody test to regulatory agencies in the coming weeks.
The ELISA test, which can detect IgM and IgG antibodies to SARS-CoV-2, is designed to run open-platform software systems. In addition to diagnosis, serological tests such as this will support epidemiological efforts to track the spread of the novel coronavirus.
Thermo Fisher, who received emergency FDA approval for their Applied Biosystems TaqPath Combo Kit in March says that while molecular testing is considered the gold standard in active infections, combining it with serological testing offers greater clinical efficacy.
Gianrico Farrugia, president and CEO of the Mayo Clinic commented on the news: “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.”
The OmniPath test will undergo clinical evaluation at the Mayo Clinic as Thermo Fisher prepare to seek FDA Emergency Use Authorization (EUA) and international regulatory authorisations in the coming weeks. Manufacturing will promptly begin at their US and European production sites.