US life sciences company Thermo Fisher Scientific said that it will collaborate with China-based WuXi Diagnostics and Mayo Clinic to develop a total antibodies Covid-19 test called the Thermo Scientific OmniPath COVID-19 Total Antibody ELISA test.
The new antibody test development is said to emerge from an ongoing partnership between the three organizations, which includes clinical evaluation and support from Mayo Clinic, a US-based academic medical center.
Thermo Fisher will pursue the emergency use authorization (EUA) from the US Food and Drug Administration apart from approvals from other international regulatory authorizations for the total antibodies Covid-19 test in the coming weeks.
Marc N Casper – Thermo Fisher Scientific Chairman, President and CEO 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.”
According to Thermo Fisher, molecular tests like its own Applied Biosystems TaqPath Combo Kit are regarded as the gold standard to determine an active COVID-19 infection in people. The life sciences company said that serological tests are used for finding out if a patient has antibodies to SARS-CoV-2 that indicate if they have had or still have the virus and have developed an immune response. When used in combination, the molecular and serological tests offer better clinical efficacy, support contact tracing while boosting epidemiological efforts to prevent the spread of the virus, said Thermo Fisher.
The company said that the new Thermo Scientific OmniPath Covid-19 Total Antibody ELISA test if approved will be used for detecting Immunoglobulin M (IgM) and Immunoglobulin G (IgG) to find out the presence of the SARS-CoV-2 virus in patients.
The test has been designed to run on an open instrument platform, and the determination of antibody status can assist in the diagnosis of the infection during its acute and recovery stages, said Thermo Fisher.
The US life sciences company is planning to begin the manufacturing of the Thermo Scientific OmniPath Covid-19 Total Antibody ELISA test at its US and European sites in the coming few weeks in preparation of submitting application seeking the FDA’s EUA.
Jason Liu – CEO of WuXi Diagnostics said: “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.
“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.”