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FDA Grants Emergency Use Authorization for Babson Diagnostics Coronavirus Assay

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Babson Diagnostics' SAR-CoV-2 immunoassay.

The test is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in human serum and plasma, and is performed on Siemens Healthineers' Atellica IM Analyzer, according to the FDA. The test may only be performed by the Austin, Texas-based company.

In May, Babson signed an agreement to use its SARS-CoV-2 assay to provide serology testing services for a study of immune responses to the virus being conducted at the University of Texas at Austin's Dell Medical School.