GenScript Files for EUA of Rapid SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript Biotech announced the company has filed for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to market its cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first test submitted for regulatory approval that specifically detects neutralizing antibodies to SARS-CoV-2, the virus that causes COV-19, without the use of live virus. Current serological antibody tests identify prior exposure to the virus by detecting the presence of antibodies from an immune response, but do not indicate whether these antibodies are neutralizing antibodies.

A virus neutralization test detects the presence of neutralizing antibodies, which are key biomarkers of immunity and act to protect the body by blocking the virus's entry into the cell. Traditional virus neutralization tests require live virus and cells and must be performed in a biosafety containment facility staffed by highly skilled personnel, with results often taking days. The cPass kit enables detection of neutralizing antibodies within an hour, without the need for live virus and biosafety containment, making it broadly available to standard labs in hospitals and clinics. The kit, which is compatible with both manual, automated and high-throughput immunoassay workflows such as ELISA, has received CE marking for commercial use as an in vitro diagnostic product in Europe.

"GenScript's cPass kit would be a valuable tool in our fight against the SARS-CoV-2 outbreak, providing laboratories with a fast, accurate method of testing for neutralizing antibodies against this virus," said David Martz, vice president of new product management in Life Science at GenScript. "We believe that the cPass test kit could be critical in assessing herd immunity, durability of protective immune response and efficacy of SARS-CoV-2 vaccine candidates."

Besides detecting neutralizing antibodies, the cPass kit is species-independent and isotope-independent, enabling scientists and clinicians to screen antibodies derived from any source, such as rabbits, ferrets and other animals, for zoonotic surveillance research. It employs novel technology invented by Professor Wang Linfa, director of Duke-National University of Singapore's Emerging Infectious Diseases program, and team. The cPass kit has also been validated with samples of patients from PROTECT, a multi-centered Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections, coordinated by Singapore's National Centre for Infectious Diseases and granted Singapore's Health Sciences Authority's (HSA) provisional authorization for clinical use.