FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use

Source: ABC News

October 8, 2024, 12:56 PM


The U.S. Food and Drug Administration authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday evening. This means the Healgen Rapid Check COVID-19/Flu A&B Antigen Test is available without a prescription. The FDA said the test is for those who are experiencing respiratory symptoms.

While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency. The new combination test uses a nasal swab sample to deliver at-home results for COVID-19 and influenza in approximately 15 minutes.

Healgen's test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu. "As we enter this year's annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives," said Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, in a statement.

"Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home." "The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions," the statement continued.


The Healgen Rapid Check COVID-19/Flu A&B Antigen Test seen here.
Healgen

Read more: https://abcnews.go.com/Health/fda-authorizes-1st-counter-combo-flu-covid-test/story?id=114591002