Instant Report

Date: 10-Nov-2020

US FDA Grants EUA To GenScripts CPass SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript USA Inc., the world's leading research reagent provider, announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This is the first commercially available test in to specifically detect neutralizing antibodies in patient samples without the use of live virus.

Neutralizing antibodies, a subset of antibodies that are specifically able to block the ability of the virus to enter a cell, are widely recognized biomarkers of immunity. The test measures the presence of neutralizing antibodies in patients recovering from COVID-19 or receiving a vaccine.

The conventional method for measuring neutralizing antibodies in patient samples requires testing to be performed in a high safety-level facility (BSL3) staffed with specialized personnel. Typically, results from the live virus assay are available in several days and due to the unpredictable nature of the live virus and live cells reagents used, these tests are also difficult to standardize. Results from different facilities may vary, even if performed using the same protocol. In contrast, the cPass kit utilizes pure proteins that can be produced in a more reproducible way. The detection of the presence of neutralizing antibodies can also be performed in most standard laboratories with short turnaround time (~1hr), making it broadly available and much more consistent between different facilities. Furthermore, a comparison of the direct clinical performance between the conventional live virus and the cPass assay shows results from both tests are strongly correlated.

"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," said David Martz, vice president of new product management in Life Science Group at GenScript, "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."

"This cPass test can be used to screen animals for SARS-CoV-2 infection without modification, as it is a species independent," added Professor Linfa Wang, director of Duke-National University of Singapore's Emerging Infectious Diseases program.

The cPass kit is yet another example of GenScript's continued commitment in supporting the healthcare community in combatting COVID-19 infections.

GenScript Biotech Corporation is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform and the industrial synthesis product platform