FDA Clears First 4-in-1 Home Test for RSV, Flu A/B, and COVID-19

The U.S. Food & Drug Administration has granted 510(k) clearance to ACON Laboratories for the Flowflex® Plus RSV + Flu A/B + COVID Home Test, marking a significant milestone in home diagnostics. This innovative product represents the first FDA-cleared 4-in-1 respiratory home test capable of detecting and differentiating between respiratory syncytial virus, influenza A, influenza B, and SARS-CoV-2 antigens from a single nasal swab sample. The clearance establishes multiple firsts in the home testing market, including the first RSV home test and the first respiratory infection home test authorized for children aged 6-23 months when administered by an adult using ACON's proprietary nasal swab guard.

The test's ability to simultaneously identify four common respiratory pathogens addresses a critical need in public health management. Since symptoms of respiratory infections often overlap, accurate differentiation is essential for appropriate treatment decisions and improved health outcomes. The lateral flow immunoassay design allows for rapid results in home settings, providing consumers with immediate information about their respiratory health status. This development is particularly significant for vulnerable populations, including young children, elderly individuals, and immunocompromised patients who face higher risks from respiratory infections.

Michael Lynch, Vice President of Sales & Marketing at ACON Laboratories, emphasized the product's potential impact on consumer health management. The test enables individuals to take proactive control of their respiratory health while providing peace of mind to parents and caregivers of at-risk populations. The domestic manufacturing at ACON's San Diego facility ensures consistent supply and quality control for this groundbreaking diagnostic tool. As the Flowflex brand maintains its position as America's leading home test brand according to Circana Retail Sales Data, this new addition expands the company's portfolio of accessible health solutions.

The Flowflex Plus RSV + Flu A/B + COVID Home Test will be available through major retail channels later this year, making comprehensive respiratory testing accessible to consumers nationwide. This advancement in home diagnostics represents a significant step forward in empowering individuals to manage their health proactively while supporting broader public health initiatives through early detection and differentiation of respiratory illnesses. Additional information about authorized distributors and retail partners can be found at https://www.flowflexcovid.com.