Healgen Scientific Receives De Novo Marketing Authorization for COVID-19/Flu At-Home Combo Test from FDA

The Healgen Rapid Check antigen test ® COVID-19/Flu A&B was supported by the Independent Test Assessment Program (ITAP), a technical program of the National Institutes of Health (NIH) called Rapid Acceleration of Diagnostics (RADx ® ).

HOUSTON, October 9, 2024 /PRNewswire/ — Healgen Scientific LLC, a leading innovator in diagnostic solutions, announces that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for the Healgen Rapid Check® COVID-19 antigen test. 19/Flu A&B over the counter. Click here to read the FDA press release. The FDA’s De Novo procedure is designed for medical devices that do not have a legally marketed comparator device and provides a unique opportunity for the development of a new device classification that can improve patient care and outcomes .

Combo Cassette (PRNewsfoto/Healgen)

The over-the-counter Healgen Rapid Check® COVID-19/Flu A&B Antigen Test provides rapid, accurate and convenient detection of COVID-19, Influenza A and Influenza B. “Our combination test fills an important gap in clinical diagnostic tests by providing a reliable and user-friendly solution for individuals to test themselves at home,” says Dr. Bingliang Fang, CEO of Healgen. “Early diagnosis allows for earlier initiation of appropriate treatment, which improves health outcomes and reduces disease transmission. »

Data validation of Healgen’s at-home test has been confirmed by the Independent Test Assessment Program (ITAP), part of the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) technical program. ITAP evaluated the quality, accuracy and reliability of Healgen’s Rapid Check COVID-19/Flu A&B antigen test, and found it to have greater than 90% and 99% sensitivity and specificity, respectively. “This De Novo marketing authorization for Healgen highlights the success of the RADx Tech program and ITAP in accelerating the authorization of at-home testing, and will serve as an important public health tool as we approach fall and seasonal respiratory viruses,” says Rebekah NealVice President of Marketing at VentureWell. “VentureWell is proud to have played a role in this collaboration as the NIH/NIBIB Innovation Funnel Commercialization Center.”

A simple nasal swab can quickly determine whether symptoms are due to COVID-19, influenza A or influenza B. This eliminates the need for multiple tests, reducing the burden on health care systems. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for symptomatic individuals at least 14 years of age, or at least 2 years of age and collected by adults, within the first five days.

“This De Novo authorization is an important milestone for Healgen. With our state-of-the-art production facility, we plan to increase production of our respiratory tests to meet global demand for tests for seasonal viruses next fall,” says Bryan Fangpresident of Healgen.

Healgen’s commitment to quality and innovation is evident in the rigorous development and validation process applied to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test has been designed to meet the highest standards of performance, including accuracy, reliability and ease of use, so that users can be confident in the results they receive.

This project was partially funded by federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institutes of Health, the Department of Health and Human Services, under the contracts n° 75N92022D00010 and 75N92022D00013.

About Healgen

Healgen Scientific, LLC, dedicated to improving health outcomes worldwide, is a leading provider of high-quality healthcare products and solutions. With a focus on innovation, quality and affordability, Healgen develops and markets healthcare products and solutions that enable users and healthcare professionals to make informed patient care decisions. . Healgen’s mission is to improve global health and create a healthier world for all.

For more information, please visit the Healgen website or contact [email protected] for media inquiries. The press release announcing the news is available on the FDA website.

Rapid Check® is a registered trademark of Healgen Scientific, LLC. RADx® is a registered trademark of the United States Department of Health and Human Services.

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