Curated News
By: NewsRamp Editorial Staff
October 28, 2025
FDA Clears First 4-in-1 Home Test for RSV, Flu & COVID
TLDR
- ACON Laboratories' FDA-cleared 4-in-1 home test provides early detection advantage for multiple respiratory viruses, enabling faster treatment decisions and better health outcomes.
- The Flowflex Plus test uses lateral flow immunoassay technology to simultaneously detect RSV, influenza A/B, and COVID antigens from self-collected nasal swab specimens.
- This innovative home test empowers families to protect vulnerable populations including young children and the elderly, promoting better community health and peace of mind.
- ACON's groundbreaking test is the first FDA-cleared 4-in-1 respiratory home test that can detect RSV, flu, and COVID simultaneously, even for infants as young as 6 months.
Impact - Why it Matters
This development matters because it fundamentally changes how people can manage respiratory health at home. For the first time, consumers can quickly distinguish between four major respiratory illnesses—RSV, influenza A, influenza B, and COVID-19—without visiting a healthcare facility. This is particularly crucial during respiratory season when these viruses often circulate simultaneously with overlapping symptoms. Early identification enables faster treatment decisions, potentially reducing severe outcomes and transmission risks. The test's authorization for children as young as 6 months addresses a critical gap in pediatric care, giving parents immediate answers about their child's respiratory symptoms. For vulnerable populations including the elderly and immunocompromised, this test provides accessible diagnostic capabilities that could significantly impact treatment timing and outcomes.
Summary
ACON Laboratories, Inc., a leading global medical device manufacturer, has achieved a significant regulatory milestone with the FDA's 510(k) clearance of its groundbreaking Flowflex® Plus RSV + Flu A/B + COVID Home Test. This innovative over-the-counter rapid antigen test represents a major advancement in home diagnostics, as it's the first device capable of simultaneously detecting four different respiratory pathogens—respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2—from a single nasal swab sample. Manufactured domestically at ACON's state-of-the-art facility in San Diego, California, this 4-in-1 test allows consumers to quickly identify which specific respiratory infection they might have in the comfort and privacy of their own homes, providing crucial information for early treatment decisions that can lead to better health outcomes.
The Flowflex Plus test establishes multiple industry firsts, including being the inaugural FDA-cleared RSV home test and the first respiratory home test authorized for children aged 6-23 months when administered by an adult using ACON's proprietary nasal swab guard. According to Michael Lynch, VP of Sales & Marketing, this "game-changing" product reflects the company's commitment to empowering consumers to take charge of their health. The test's ability to differentiate between similar respiratory symptoms is particularly valuable for parents of young children, elderly individuals, immune-compromised patients, and those in contact with at-risk populations. As America's #1 home test brand, Flowflex will make this innovative product widely available through major retailers later this year, with authorized distributors and retail partners listed at www.flowflexcovid.com.
Source Statement
This curated news summary relied on content disributed by 24-7 Press Release. Read the original source here, FDA Clears First 4-in-1 Home Test for RSV, Flu & COVID
