**FDA Authorizes First At-Home Flu and COVID-19 Test for Non-Prescription Use**

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, marking a significant advancement in at-home diagnostic testing. This non-prescription test allows individuals to use a nasal swab sample to detect COVID-19 and influenza A and B viruses, with results ready in approximately 15 minutes.

This newly authorized test identifies proteins from SARS-CoV-2, the virus responsible for COVID-19, and the influenza A and B viruses, offering a convenient and quick solution for those experiencing respiratory symptoms. Notably, this is the first over-the-counter test authorized to detect influenza through the traditional premarket review pathway, which permits its marketing even without an emergency use declaration. Previous over-the-counter flu and COVID-19 tests had only been available under emergency use authorization.

Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health, emphasized the importance of this authorization as the flu season approaches. "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," Dr. Tarver stated.

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is intended for individuals aged 14 and older, who can self-administer the test, and for children aged 2 and older, whose test must be administered by an adult. The FDA's review included data from a study demonstrating the test's accuracy: 99% for negative and 92% for positive SARS-CoV-2 samples, 99.9% for negative Flu A and B samples, and 92.5% and 90.5% for positive Flu A and Flu B samples, respectively.

Validation of the test was supported by the Independent Test Assessment Program (ITAP), part of the NIH's Rapid Acceleration of Diagnostics (RADx®) Tech program, launched in 2021. ITAP aims to accelerate test evaluation to facilitate the FDA's regulatory review process and ensure the availability of high-quality diagnostic tests.

Despite the promising accuracy, the FDA noted that, like all rapid antigen tests, this test could yield false negatives due to generally lower sensitivity than molecular tests. Therefore, individuals with persistent symptoms are advised to seek further medical consultation, even if they receive a negative result. Those who test positive are urged to take precautions to prevent virus spread and get follow-up care from their healthcare provider.

With the De Novo authorization, the FDA is laying down special controls for labeling and performance testing, establishing a new regulatory classification. Future devices of the same type with similar intended uses can now follow a less burdensome 510(k) pathway, demonstrating substantial equivalence to this predicate device to gain marketing clearance.

The FDA, under the U.S. Department of Health and Human Services, continues its mission to protect public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, medical devices, and more. This latest authorization is part of its ongoing efforts to support the development and availability of reliable at-home tests for various medical conditions.