Healgen Scientific Gains FDA De Novo Authorisation for At-Home COVID-19 and Flu Test
Wednesday, October 09, 2024
Healgen Scientific has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) Healgen Rapid Check® COVID-19/Flu A&B Antigen Test.
The Healgen Rapid Check® test is designed to provide rapid and reliable detection of respiratory infections, enabling early diagnosis and timely treatment. It eliminates the need for separate tests, thus reducing strain on healthcare services.
The test is authorized for individuals aged 14 and older, or for adult-collected samples from individuals aged 2 and above, who are experiencing symptoms within five days.
This test allows individuals to self-test at home for COVID-19, influenza A, and influenza B using a nasal swab. The De Novo pathway is used for medical devices without an existing comparable device, offering an opportunity to create a new device classification that can enhance patient care.
The Independent Test Assessment Program (ITAP), under the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech initiative, validated the test’s data.
The test demonstrated sensitivity of over 90% and specificity exceeding 99%, confirming its high accuracy and reliability. This authorization marks a significant achievement for Healgen and highlights the role of RADx and ITAP in accelerating the approval of home-based tests.
Healgen plans to scale up production at its advanced manufacturing facility to meet the anticipated demand during the upcoming respiratory virus season.
The project has also received partial federal funding through the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part of NIH, under specific contracts.
Source: prnewswire.com
