NEW YORK – Thermo Fisher Scientific said on Wednesday that it is collaborating with WuXi Diagnostics and the Mayo Clinic to develop a COVID-19 total antibody test.
As part of the ongoing collaboration, Mayo Clinic is clinically evaluating the new assay, called Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test. Thermo Fisher will seek Emergency Use Authorization from the US Food and Drug Administration and international regulatory authorizations for the test over the next few weeks.
As it prepares to submit for EUA, Thermo Fisher will begin manufacturing the test at sites in the US and in Europe in coming weeks.
The test will detect immunoglobulin M and G to help clinicians determine if a patient has been exposed to SARS-CoV-2. It is designed to run on an open instrument platform and will aid in the diagnosis of COVID-19 during the acute and recovery stages of infection.
"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," said Mayo Clinic CEO and President Gianrico Farrugia in a statement.