NEW YORK – The US Food and Drug Administration said Monday that it has granted marketing authorization for Healgen Scientific's home-use combination test for flu and COVID-19.
While the agency has previously granted Emergency Use Authorizations for multiple home-use combination tests, Healgen's Rapid Check COVID-19/Flu A&B Antigen Test is the first over-the-counter combination test to gain market access through the conventional regulatory pathway outside of a public health emergency. Healgen received de novo marketing authorization for the lateral flow assay, which is used for the quantitative detection and differentiation of COVID-19 and flu A/B nucleocapsid protein antigens in anterior swab samples within the first five days of signs and symptoms of upper respiratory tract infection.
The test is authorized for use with self-collected nasal swab samples from individuals aged 14 and older or adult-collected samples from individuals aged 2 years and older.
The agency noted that it established with the de novo authorization additional labeling and performance testing requirements that are meant to assure the safety and effectiveness of this type of test. Those special controls were established along with the creation of a new regulatory classification for similar devices, which will allow the review of similar tests through the FDA's 510(k) marketing clearance pathway.
"Today's authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home," Michelle Tarver, acting director of the FDA Center for Devices and Radiological Health, said in a statement. "The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions."
Healgen President Bryan Fang noted that the company plans to increase the production of its respiratory tests to meet global demand this fall.
The FDA said that the test was used in a study to correctly identify 99 percent of negative and 92 percent of positive SARS-CoV-2 samples, 99.9 percent of negative flu A/B samples, 92.5 percent of positive flu A samples, and 90.5 percent of positive flu B samples. The test had been validated through data from the Independent Test Assessment Program (ITAP) that is within of the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) Tech program. The ITAP is used to support FDA regulatory reviews of diagnostic tests.
Healgen also noted that the development of the COVID-19 and flu A/B combination test had been supported through federal funding from two contracts with the NIH National Institute of Biomedical Imaging and Bioengineering.
The FDA published 18 months ago its guidance document for transitioning COVID-19 tests and other devices from EUAs to full marketing and regulatory authorizations. At the time, the agency was winding down its EUA process for COVID-19 tests and directing test developers to apply for traditional regulatory reviews.