GenScript announced today that it received FDA emergency use authorization (EUA) for its cPass SARS-CoV-2 neutralizing antibody detection kit.
Piscataway, N.J.-based GenScript touts its test as the first commercially available diagnostic for specifically detecting neutralizing antibodies without the use of live virus. It measures the presence of neutralizing antibodies in any sample, both in patients recovering from COVID-19 or those vaccinated against COVID-19, according to a news release.
Results from the live virus assay are difficult to standardize, the company said, while results from different facilities may vary, even under the same protocol. Conversely, cPass uses pure proteins that the company said can be offered in a more reproducible way with shorter turnaround time as well.
“Unlike commercially available antibody-based tests that are routinely used for detecting prior exposure to the virus, the cPass kit can assess both prior exposure and the presence of neutralizing antibodies in convalescent patients,” GenScript VP of new product management David Martz said in the release. “The cPass kit is also a valuable tool for assessing vaccine performance. When vaccine companies start phase II or III trials, a standardized test that can detect neutralizing antibodies will be needed for a large cohort of patients to evaluate the efficacy of vaccines within different populations and regions.”