The FDA has given a green light to an at-home test that checks for both COVID-19 and the flu—a first for the agency, outside of the additional authorities that it received during the coronavirus pandemic.
Previous over-the-counter combination tests had been granted Emergency Use Authorizations. The Rapid Check test from Healgen received a de novo clearance through the FDA’s traditional product review pathways, allowing its use without a prescription—marking a milestone in OTC tests for influenza, as well.
The antigen test was brought up through the National Institutes of Health’s Independent Test Assessment Program, part of the pandemic-era Rapid Acceleration of Diagnostics initiative known as RADx. The 15-minute nasal swab screener detects the bug behind COVID-19 as well as influenza A and B.
“This de novo authorization represents a significant milestone for Healgen,” President Bryan Fang said in a statement, adding that the Chinese company’s Texas-based subsidiary plans to scale up its respiratory test production ahead of the fall sickness season in the U.S.
A previous report by Houston Public Media profiled a new production facility that aims to produce more than 800,000 tests per day at full capacity, making it Healgen’s largest in the country.
“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, acting director of the FDA’s devices center, said in an agency announcement. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
The test is designed for self-use by people ages 14 and up, or as young as two when performed by an adult. According to the FDA, a study of SARS-CoV-2 samples showed a false-negative rate of about 1% and a false-positive rate of about 8%, with similar accuracy in the flu.