FDA Grants Marketing Authorization to First OTC Flu, COVID-19 Combination Test
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is the first at-home test to be granted marketing authorization using a traditional premarket review pathway.
The FDA has granted marketing authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test for use by individuals experiencing respiratory symptoms, the agency announced in a release.1 The over-the-counter (OTC) test is the first to be granted marketing authorization using a traditional premarket review pathway, as other similar tests are only currently available under emergency use authorization (EUA).
FDA Grants Marketing Authorization to First OTC Flu, COVID-19 Combination Test / waranyu - stock.adobe.com
The granting of the De Novo marketing authorization was based on data from a study assessing the Healgen rapid test’s quality, accuracy and reliability in individuals with signs and symptoms of COVID-19 and influenza. The study found the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples. It also correctly identified 99.9% of negative flu A and B samples, 92.5% of positive flu A samples and 90.5% of positive flu B samples.
READ MORE: Examining Flu, COVID-19 Infection Outcomes in Children
“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives,” Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, said in a release.1 “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home. The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for use in individuals aged 14 years or older, or adult-collected samples from individuals aged 2 years or older, who are experiencing respiratory symptoms. The test, meant to be used within the first 5 days from when symptoms begin, uses a nasal swab to collect samples and delivers results in 15 minutes by detecting proteins from SARS-CoV-2 and influenza A and B.
The FDA said in its release that rapid antigen tests generally have lower sensitivity compared to molecular tests, which means there is a risk of false negative results. Individuals who receive a negative test result but continue to experience symptoms should seek follow up care with their health care provider, as they could still have the flu, COVID-19, or another respiratory infection.
"Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home," Bingliang Fang, CEO of Healgen, said in a release.2 "Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission."
Validation data for the test was gathered through the Independent Test Assessment Program (ITAP). The program, which is part of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Tech program, was started in 2021 to accelerate test evaluation to support the FDA’s regulatory review, as well as the availability of accurate and reliable diagnostic tests to the general public.
"This De Novo authorization represents a significant milestone for Healgen,” Bryan Fang, president of Healgen, said in a release.2 “With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season."
READ MORE: COVID-19 Resource Center
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