Thermo Fisher Scientific Inc., a titan in the US device industry and listed on the NYSE under the ticker (TMO), has unveiled the development of a serology test designed to detect the SARS-CoV-2 coronavirus. This collaborative effort with China’s WuXi Diagnostics and the prestigious US medical institution, Mayo Clinic, is now poised to seek approval from the US FDA via the Emergency Use Authorization (EUA) process, with a parallel filing for international clearance.
The manufacturing of the diagnostic kit is set to commence shortly in both Europe and the US. As detailed in the company’s press release, the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test is a significant advancement, enabling physicians to identify whether individuals have previously encountered SARS-CoV-2 by measuring the presence of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies in blood samples.
Understanding the antibody status of the population is crucial for governments as they assess the proportion of individuals who may have developed an immune response to the virus. This information is instrumental in informing decisions regarding the easing of restrictions and the gradual reopening of economies.
Thermo Fisher Scientific is no newcomer to the fight against COVID-19, already providing the PCR-based molecular test, Applied Biosystems TaqPath Combo Kit, which is used to detect active SARS-CoV-2 infections in patients.
