Healgen Scientific LLC, a prominent player in diagnostic solutions, has secured De Novo marketing authorisation from the U.S. Food and Drug Administration (FDA) for its Healgen Rapid Check® COVID-19/Flu A&B Antigen Test, allowing for over the counter (OTC) sales. This development marks a significant step forward in home diagnostics for respiratory infections.
The FDA’s De Novo pathway is tailored for medical devices that lack a legally marketed comparison. This approach paves the way for new device classifications aimed at enhancing patient care and outcomes. Healgen’s innovative test is designed for rapid, accurate, and convenient detection of COVID-19, influenza A, and influenza B infections, providing a user-friendly solution for individuals testing themselves at home.
Dr Bingliang Fang, CEO of Healgen, emphasised the importance of the new test, stating, “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.” He highlighted that early diagnosis facilitates quicker treatment initiation, ultimately improving health outcomes and minimising the risk of disease transmission.
The validation of Healgen’s at-home test was backed by the Independent Test Assessment Program (ITAP), which is part of the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech programme. ITAP evaluated the quality, accuracy, and reliability of the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, concluding that it demonstrated a sensitivity of over 90% and specificity exceeding 99%. Rebekah Neal, Vice President for Commercialization at VentureWell, noted the significance of the De Novo marketing authorisation, stating, “This highlights the success of the RADx Tech programme and ITAP in expediting the authorisation of home-based tests, which will be a vital part of the public health toolkit as we approach the fall respiratory virus season.”
The Healgen Rapid Check test employs a simple nasal swab, allowing individuals to quickly ascertain whether their symptoms stem from COVID-19, influenza A, or influenza B. This eliminates the need for multiple tests and eases the strain on healthcare systems. The test is authorised for individuals aged 14 and above, or for adult-collected samples from those aged 2 years and older experiencing symptoms within the first five days of illness.
Bryan Fang, president of Healgen, expressed optimism about the future, stating, “This De Novo authorisation represents a significant milestone for Healgen. With our state-of-the-art manufacturing facility, we plan to ramp up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season.”
Healgen’s commitment to quality and innovation is reflected in the rigorous development and validation processes the Healgen Rapid Check COVID-19/Flu A&B Antigen Test has undergone. The test has been designed to meet high-performance standards, including accuracy, reliability, and ease of use, ensuring users can trust the results.
This initiative has received partial funding from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of the National Institutes of Health and the Department of Health and Human Services. For more information, please visit Healgen’s website