WALTHAM, Mass.—Thermo Fisher Scientific, Inc. announced today that the company will be developing a total antibodies test in collaboration with WuXi Diagnostics and the Mayo Clinic. The new test will be an expansion of ongoing collaborations between all three organizations, including clinical evaluation and support from Mayo Clinic. Thermo Fisher will seek U.S. Food and Drug Administration Emergency Use Authorization (EUA) and international regulatory authorizations for the test over the next few weeks.
“Since the outbreak was first detected, we have mobilized our scientific, regulatory and commercial teams to support virus analysis, identification [and] deployment of personal protective equipment, as well as development of therapies and vaccines,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher. “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.”
Once approved for use, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test will detect immunoglobulin M and immunoglobulin G to help clinicians determine whether 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 diagnosing the disease during the acute and recovery stages of infection.
“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,” noted Jason Liu, Ph.D., chief executive officer of WuXi Diagnostics. “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.”
The global call to ramp up testing requires a combination of both PCR-based molecular tests and serological tests. Molecular tests are considered the gold standard for determining if a patient has an active infection. Serological tests determine if a patient has antibodies to SARS-CoV-2 that indicate whether they have had — or still have — the virus, and whether they have built up an immune response. When used in combination these tests provide greater clinical efficacy, support contact tracing and enhance epidemiological efforts to stop the spread of the virus.
“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, [the] testing development abilities of WuXi Diagnostics, and [the] clinical and laboratory expertise of Mayo Clinic physicians and scientists,” added Gianrico Farrugia, M.D., chief executive officer and president of the Mayo Clinic.
Thermo Fisher plans to begin manufacturing the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test at its sites in the U.S. and Europe in the next few weeks, as it prepares to submit for an EUA.