Mayo Clinic announced that it launched a new SARS-CoV-2 neutralizing antibody test in support of efforts to establish therapies and vaccines for COVID-19.
As part of the Expanded Access Program for Convalescent Plasma and other critical research efforts, Mayo Clinic intends to make the test available to select labs, blood banks and biopharma clients later this month.
Mayo Clinic designed the new test to measure the level of neutralizing antibodies against SARS-CoV-2, the virus causing COVID-19. The test provides semi-quantitative detection of total neutralizing antibodies in human serum. After infection, most will develop an immune response to COVID-19, including the production of neutralizing antibodies against the SARS-CoV-2 spike glycoprotein. However, it’s currently unknown for how long the neutralizing antibodies persist after infection.
The test should only be ordered upon confirmation of prior infection and it should not be used to diagnose SARS-CoV-2 infection, according to a news release.
It was developed and clinically validated at Mayo Clinic with support from Vyriad, Regeneron Pharmaceuticals (NSDQ:REGN) and Imanis Life Sciences. The basis of the test is Vyriad’s Immuno-Cov neutralizing antibody test, while Regeneron granted a license.
“The neutralizing antibody test is a critical addition to our COVID-19 testing, expanding on the capabilities of the molecular tests used to diagnose active infection and the serology test, which indicates previous infection by identifying antibodies for the SARS-CoV-2 virus,” Mayo Clinic Laboratories president Dr. William Morice, II said in the release. “This new test provides us with incredibly important information about how effective a person’s antibodies are at neutralizing the virus. This will help us identify optimal convalescent plasma donors and ultimately help assess the efficacy of anti-SARS-CoV-2 vaccines.”
“The development of this scalable neutralizing antibody assay was the result of an extraordinary and highly integrated collaborative effort between scientific teams at four companies: Imanis Life Sciences, Vyriad, Mayo Clinic, and Regeneron,” added Vyriad CEO Dr. Stephen Russell. “We believe that the launching of the test at Mayo Clinic Laboratories fills a critical gap in the serology testing landscape and represents a significant milestone in the fight against COVID-19.”