Lucira's home test for flu and COVID-19 gets U.S. FDA nod for OTC use
Source: Reuters
February 28, 2023 11:57 PM EST Last Updated 7 hours ago
(Reuters) - Lucira Health (LHDX.O) said on Monday the U.S. Food and Drug Administration (FDA) had granted emergency use authorization for its combination diagnostic test for COVID-19 and the flu, making it the first to be available over-the-counter.
The test — called Lucira COVID-19 & Flu Home Test — is a single-use, at-home rapid test kit that provides results from self-collected nasal swab in about 30 minutes. Shares of the medical test maker rose more than four-fold to 66 cents in premarket trade.
The FDA's authorization, which came on Friday, allows the test to be purchased without a prescription and performed completely at home by individuals aged 14 years or older or collected by an adult for children two years or older.
The development comes days after Lucira filed for bankruptcy protection in the United States, and said it intended to pursue a sale of its business.
Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-authorises-luciras-home-test-flu-covid-19-2023-02-27/
Heard about this locally on the radio this morning.
