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FDA Grants Emergency Use Authorization for GenBody Point-of-Care SARS-CoV-2 Antigen Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization to GenBody's COVID-19 Ag point-of-care antigen test for SARS-CoV-2 infection.

The immunochromatographic rapid diagnostic test is designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab specimens.

It is authorized for use by any lab CLIA-certified to perform moderate-, high-, or waived-complexity tests. It may also be used in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, the FDA said.

Earlier this year, South Korea-based GenBody received a US National Institutes of Health contract to develop a visually read, single lateral flow rapid test system for SARS-CoV-2.