Roche seeks FDA Emergency Use Authorization for SARS- CoV-2 Rapid Antigen Test

Roche has submitted a request for the Emergency Use Authorization (EUA) from the U.S. FDA for a SARS-CoV-2 Rapid Antigen Test.

The test is designed to assist healthcare professionals in identifying — typically in 15 minutes — a SARS-Cov-2 infection in patients experiencing COVID-19 symptoms, according to a company release.

The rapid test includes a nasal swab sample and small, instrument-free kit that can be used by healthcare professionals at an assortment of point-of-care locations near to the patient, as well as in settings where healthcare resources may be limited.

The rapid test works by providing a yes/no answer for the presence of a pathogen — in this case, SARS-Cov-2 — in a patient sample on a strip test performed at the point of care.

While antigen tests generally have a high specificity, they are not as sensitive as molecular tests and therefore do not generate a considerable sign to the presence of a virus in a sample.

To compensate for this, negative results are analyzed with additional patient factors, such as COVID-19 exposure history, clinical symptoms, and other test results to help determine a patient’s diagnosis and ensuing treatment.

At launch, Roche anticipates to 10s of millions of SARS-CoV-2 Rapid Antigen Tests ready for distribution each month in the U.S., along with the bandwidth to roll out additional quantities as needed to assist in addressing the pandemic testing demand, the release stated.

The launch is the product of a global distribution agreement between Roche and SD Biosensor Inc that also launched the SARS-CoV-2 Rapid Antigen Test and the SARS-CoV-2 Rapid Antibody Test in countries accepting the CE Mark in 2020, according to the release.

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