WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. This innovative test marks a significant advancement as it is the first over-the-counter (OTC) diagnostic tool authorized via the traditional premarket review pathway to detect both COVID-19 and influenza viruses without needing a prescription.
The Healgen Rapid Check test is designed for individuals experiencing respiratory symptoms, offering a convenient and efficient means of testing from the comfort of home. It utilizes a nasal swab sample to deliver results in approximately 15 minutes, detecting proteins from SARS-CoV-2, the virus responsible for COVID-19, as well as influenza A and B viruses.
As respiratory illnesses like COVID-19 and influenza continue to pose significant health challenges, the availability of such a diagnostic tool is particularly timely. Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health, highlighted the importance of this authorization: “The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”
This authorization is groundbreaking in that it allows the Healgen test to be marketed without an emergency use declaration, setting it apart from other OTC flu/COVID-19 tests presently available under emergency use authorization. The test is suitable for self-administration by individuals aged 14 and older, and for those aged 2 and older with adult assistance.
The FDA’s decision was based on data from a comprehensive study involving individuals showing symptoms of COVID-19 and influenza. The test demonstrated a high accuracy rate, correctly identifying 99% of negative and 92% of positive COVID-19 cases, and 99.9% of negative and over 90% of positive cases for both influenza A and B.
Validation of the Healgen Rapid Check was facilitated through the Independent Test Assessment Program (ITAP), part of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech initiative. This collaboration underscores the commitment to accelerating the availability of high-quality diagnostic tests to the public.
Despite the convenience of rapid antigen tests, it is important to note their generally lower sensitivity compared to molecular tests, which can lead to false negatives. The FDA advises that individuals who test negative but continue to exhibit symptoms such as fever or cough should seek further evaluation from healthcare providers. Conversely, those testing positive should take necessary precautions to prevent viral spread and consult healthcare professionals for follow-up care.
The FDA’s De Novo authorization not only paves the way for this specific test but also establishes a new regulatory classification with special controls for similar future diagnostics. This classification enables subsequent devices to follow the FDA’s streamlined 510(k) pathway, facilitating quicker market access by demonstrating substantial equivalence to an established predicate device.
This authorization represents a significant leap forward in the realm of accessible, reliable at-home testing, providing crucial tools in the ongoing battle against respiratory illnesses.
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