Thermo Fisher Scientific is developing its own COVID-19 antibody test through an ongoing, three-way collaboration with WuXi Diagnostics and the Mayo Clinic, and plans to seek international authorizations for the test over the next few weeks.
Following clinical evaluation at the Mayo Clinic and its regulatory green light, the ELISA test will be available to detect both IgM and IgG antibodies to the novel coronavirus, and is designed to run on an open instrument platform.
"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," said Marc Casper, Thermo Fisher’s chairman, president and CEO.
"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,” Casper added.
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Comprehensive testing includes molecular tests for the disease, which detect the virus’ genetic material to diagnose an active infection. Thermo Fisher received an FDA emergency authorization for its PCR-based test kit in mid-March.
Meanwhile, serological tests search for antibodies in the bloodstream to gauge a person’s potential immunity and support epidemiological efforts tracking the spread of the virus. According to WuXi Diagnostics CEO Jason Liu, the company’s open-access platform for diagnostics will help advance widespread serological testing internationally.
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"Rapidly expanding access to high-quality testing requires bold collaborations across the laboratory industry,” said Gianrico Farrugia, president and CEO of the 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."
Thermo Fisher said it plans to begin manufacturing the OmniPath COVID-19 test at its production sites in the U.S. and Europe over the next few weeks as it prepares its submissions for the FDA.