Healgen’s At-Home COVID-19 & Flu Test Wins De Novo Nod

Diagnostic solutions company Healgen has earned U.S. Food and Drug Administration (FDA) de novo authorization for its Rapid Check COVID-19/Flu A&B antigen test for over-the-counter (OTC) use.
 
This, according to the FDA, is the first OTC test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway. Other OTC flu/COVID tests are currently available under emergency use authorization (EUA).
 
The test, according to Healgen, provides rapid, accurate, convenient detection of COVID-19, influenza A, and influenza B infections. Its validation was supported by the Independent Test Assessment Program (ITAP), part of National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program.
 
ITAP found the Rapid Check COVID-19/Flu A&B antigen test demonstrated sensitivity and specificity of greater than 90% and 99%, respectively.
 
The test is authorized for people aged 14 and over, or adult-collected samples from those aged two and older, who are experiencing symptoms within the first five days.
 
“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,” said Dr. Bingliang Fang, CEO of Healgen. “Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission.”
 
“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. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” said Michelle Tarver, MD, Ph.D., acting director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”