ACON Laboratories, Inc., a global medical device manufacturer based in San Diego, CA, announced today that its Flowflex Plus RSV + Flu A/B + COVID Home Test has received 510(k) clearance from the U.S. Food & Drug Administration (FDA). This over-the-counter (OTC) rapid antigen test can be administered at home, allowing consumers to simultaneously detect and differentiate respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 (COVID-19) protein antigens from a single nasal swab specimen.
The Flowflex Plus test is a lateral flow immunoassay that provides results in minutes, enabling early treatment decisions that can lead to better health outcomes. According to the company, this is the first FDA-cleared 4-in-1 respiratory home test, the first FDA-cleared 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.
Michael Lynch, VP of Sales & Marketing at ACON, stated, 'We are excited to introduce this game-changing 4-in-1 home test. This product further demonstrates our commitment to enabling consumers to take charge of their own health. Symptoms of respiratory infections can be similar, so knowing which infection you have is important for making early treatment decisions, which can lead to better outcomes.'
The test will be manufactured domestically at ACON's state-of-the-art facility in San Diego, CA. Flowflex continues to be America's #1 home test brand, according to Circana Retail Sales Data (Units sold). The Flowflex Plus RSV + Flu A/B + COVID Home Test will be widely available at major retailers later this year. A list of authorized distributors and retail partners can be found at www.flowflexcovid.com.
This clearance represents a significant advancement in at-home diagnostic testing, particularly for vulnerable populations such as young children, the elderly, and immunocompromised individuals. By offering a single test that can differentiate between four common respiratory viruses, the Flowflex Plus test aims to reduce the need for multiple tests and doctor visits, potentially easing the burden on healthcare systems during respiratory season.
The ability to test for RSV at home is especially notable, as RSV is a leading cause of hospitalization in infants and young children. Early identification can help parents make informed decisions about care and prevent the spread of the virus to others. Similarly, distinguishing between flu and COVID-19 allows for appropriate antiviral treatments and isolation measures.
ACON Laboratories expects the test to bring peace of mind to parents, caregivers, and individuals in contact with at-risk populations. With the test's expected availability at major retailers later this year, consumers will have greater access to comprehensive respiratory diagnostics without leaving home.
