SILVER SPRING, Md. , Oct. 7, 2024 /PRNewswire/ -- Today, the U.
S. Food and Drug Administration granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu).
The test detects proteins from both SARS-CoV-2 (the virus that causes COVID-19) and influenza A and B (the viruses that cause flu). This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization.
"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. Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home," said Michelle Tarver , M.D.
, Ph.D., acting director of the FDA's Center for Devices and Radiological Health.
"The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.