Thermo Fisher intends to start manufacturing the antibody test at its US and European sites
Thermo Fisher Scientific has unveiled its plans to develop a total antibody Covid-19 test in collaboration with WuXi Diagnostics and Mayo Clinic.
The new antibody test will be developed under an ongoing collaboration between the three companies, including clinical evaluation and support from Mayo Clinic,
As part of the collaboration, Thermo Fisher will seek US FDA Emergency Use Authorization (EUA) and international regulatory authorisations for the test in the coming weeks.
Mayo Clinic chief executive officer and president Gianrico Farrugia said: “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, testing development abilities of WuXi Diagnostics, and clinical and laboratory expertise of Mayo Clinic physicians and scientists.”
Thermo Fisher will manufacture the Covid-19 total antibody test in the US and Europe
Molecular tests are considered the gold standard for determining an active Covid-19 infection in patients.
On the other hand, serological tests are used to determine if a patient has antibodies to SARS-CoV-2 that indicate whether they have had the virus and have built up an immune response.
Once approved, the new Thermo Scientific OmniPath Covid-19 Total Antibody ELISA test will be used for detecting Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to determine the presence of SARS-CoV-2 in patients.
The test has been designed to run on an open instrument platform, and the determination of antibody status would help in the diagnosis of the disease during the acute and recovery stages of infection.
Thermo Fisher intends to start manufacturing the Thermo Scientific OmniPath Covid-19 Total Antibody ELISA test at the company’s US and European sites and is planning to submit for EUA.
Thermo Fisher Scientific chairman, president and chief executive officer Marc N Casper said: “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.
“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.”
Recently, the company secured the expanded FDA EUA for its multiplex real-time PCR test to detect nucleic acid from SARS‑CoV‑2, which causes Covid-19.