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GenScript Gets FDA Emergency Use Authorization for Coronavirus Neutralizing Antibody Assay

NEW YORK — The US Food and Drug Administration on Friday granted Emergency Use Authorization to GenScript Biotech's cPass SARS-CoV-2 Neutralization Antibody Detection Kit.

It is the first SARS-CoV-2 neutralizing antibody test to receive EUA, the FDA said.

The blocking ELISA detection assay, which is designed to mimic the virus neutralization process, detects total neutralizing antibodies to SARS-CoV-2 in human serum and plasma. Results are provided in around one hour.

According to Piscataway, New Jersey-based GenScript, the test does not require live virus, allowing for its use in standard research or clinical diagnostic labs that do not have a biosafety level 3 rating.

In addition to detecting prior SARS-CoV-2 exposure and the presence of neutralizing antibodies in convalescent patients, the test is expected to aid in the assessment of SARS-CoV-2 vaccine candidates where a standardized test that can detect neutralizing antibodies will be needed for large patient cohorts, GenScript said. It can also be used to screen animals for SARS-CoV-2 infection without modification.

The test is authorized for use by any lab CLIA-certified to perform high-complexity tests, according to the FDA.