Orginal from: PR Newswire
Healgen Scientific LLC, a leading innovator in diagnostic solutions, announced the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for Healgen Rapid Check® COVID-19/Flu A&B Antigen Test for over-the-counter (OTC) use. Click here for FDA Release. The FDA's De Novo pathway is designed for medical devices that do not have legally marketed comparison device and is a unique opportunity for development of a new device classification that can improve patient care and outcomes.
The OTC Healgen Rapid Check® COVID-19/Flu A&B Antigen Test provides rapid, accurate and convenient detection of COVID-19, influenza A and influenza B infections. "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," says Dr. Bingliang Fang, CEO of Healgen. "Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission."
Validation of Healgen's at-home test data was supported through the Independent Test Assessment Program (ITAP), part of National Institutes of Health's (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program. ITAP assessed Healgen's Rapid Check COVID-19/Flu A&B Antigen Test's quality, accuracy and reliability, and found it demonstrated sensitivity and specificity of greater than 90% and 99%, respectively. "This De Novo marketing authorization for Healgen highlights the success of the RADx Tech program and ITAP in speeding the authorization of home-based tests, and will be an important part of the public health toolkit as we move into the fall respiratory virus season," says Rebekah Neal, VentureWell Vice President for Commercialization. "VentureWell is proud to have played a role in this collaboration as the NIH/NIBIB Innovation Funnel Commercialization Center."
With a simple nasal swab, individuals can quickly determine whether their symptoms are due to COVID-19, Influenza A or Influenza B. This eliminates the need for multiple tests and reduces the burden on health care systems. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for individuals aged 14 years or older, or adult-collected samples from individuals aged 2 years or older, who are experiencing symptoms within the first five days.
"This De Novo authorization represents a significant milestone for Healgen. With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season," says Bryan Fang, president of Healgen.
Healgen's dedication to quality and innovation is evident in the rigorous development and validation process that the Healgen Rapid Check COVID-19/Flu A&B Antigen Test has undergone. The test has been designed to meet the highest performance standards, including accuracy, reliability, and ease of use, ensuring that individuals can trust the results they receive.
This project has been partly funded with federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract Nos. 75N92022D00010 and 75N92022D00013.
