FDA Clears First 4-in-1 Home Test for RSV, Flu, and COVID Detection

ACON Laboratories has received 510(k) clearance from the U.S. Food & Drug Administration for its Flowflex® Plus RSV + Flu A/B + COVID Home Test, marking a significant milestone in consumer healthcare accessibility. This over-the-counter rapid antigen test represents the first FDA-cleared device capable of detecting four different respiratory pathogens simultaneously from a single nasal swab sample collected at home.

The test's clearance carries substantial implications for public health management, particularly during respiratory illness seasons when multiple viruses circulate simultaneously. The ability to differentiate between respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 infections from a single test provides consumers with critical information that can inform treatment decisions and isolation protocols. Early identification of specific respiratory infections can lead to more targeted interventions and potentially better health outcomes.

Notably, this authorization includes a groundbreaking provision for pediatric use, making it the first respiratory home test cleared for children aged 6-23 months when administered by an adult using ACON's proprietary nasal swab guard. This development addresses a significant gap in home testing availability for young children, who are particularly vulnerable to severe outcomes from respiratory infections like RSV.

The test's domestic manufacturing at ACON's San Diego facility ensures consistent supply chain reliability, while its lateral flow immunoassay technology provides rapid results that consumers can interpret at home without professional assistance. The company expects the test to be particularly valuable for parents of young children, elderly individuals, immunocompromised patients, and those who regularly interact with at-risk populations.

As the respiratory testing landscape evolves, this 4-in-1 approach represents a shift toward comprehensive diagnostic solutions that mirror the reality of co-circulating respiratory pathogens. The test's availability through major retail channels later this year, with distribution information available at https://www.flowflexcovid.com, will provide consumers with unprecedented access to multi-pathogen respiratory testing outside clinical settings.

This advancement builds on ACON's position in the home testing market, where Flowflex maintains its status as America's leading home test brand according to Circana Retail Sales Data. The integration of RSV detection alongside established flu and COVID testing capabilities addresses growing consumer demand for comprehensive respiratory health management tools that can be used proactively during illness seasons.