December 16, 2020

Argentum Update: FDA Issues EUA for BinaxNOW COVID-19 Home Test

Today, the U.S. Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test, now authorized for use at home with a prescription.

According to the FDA, if a healthcare provider suspects COVID-19, the test will be offered in partnership with a telehealth service that will take users through the sample collection process.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” said FDA Commissioner Stephen M. Hahn, M.D. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Additionally, we have learned from HHS that they plan to acquire and distribute another 30 million BinaxNOW rapid tests to communities with CLIA waivers through mid-March, which is approximately 6-8 weeks beyond the current supply. We continue to encourage those without CLIA waivers to apply to be considered for this distribution of tests.

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