Healgen's At-Home COVID-19 and Influenza Test Achieves FDA De Novo Status with Key Support from CovarsaDx® Research Team

News provided by

Oct 09, 2024, 08:43 ET

Healgen Scientific receives FDA De Novo Authorization for 2-in-1,
at-home respiratory illness test by leveraging CovarsaDx's clinical expertise

LOS ANGELES, Oct. 9, 2024 /PRNewswire/ -- CovarsaDx^®, a prominent Clinical Research Organization (CRO) renowned for its expertise in vitro diagnostics (IVDs) and medical devices, proudly announced today that a clinical research study, conducted on behalf of Healgen Scientific, LLC, through the Independent Test Assessment Program (ITAP), part of National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx^®) Tech, has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the Healgen Rapid Check^® COVID-19/Flu A&B Antigen Test.

"Through our partnership with CovarsaDx, we were able to leverage their extensive clinical expertise and resources from meticulous study planning to execution," said Bryan Fang, president of Healgen Scientific, LLC.

CovarsaDx's clinical research efforts supported Healgen, an innovator in diagnostic solutions, in receiving full clearance of an at-home test that simultaneously detects and differentiates COVID-19, influenza A, and influenza B infections with a single nasal swab. With the next respiratory season soon approaching, this cutting-edge solution will enable individuals to get results in minutes and help determine whether their symptoms are due to COVID-19, influenza A, or influenza B, ensuring timely and informed healthcare decisions.

"CovarsaDx has been part of the ITAP initiative since its inception, supporting efficient and effective clinical evaluations of products in the program through VentureWell's Clinical Evaluation Services program," says Rebekah Neal, VentureWell vice president for commercialization. "This De Novo marketing authorization for Healgen highlights the success of RADx Tech program and ITAP in speeding the production of home-based tests."

This significant achievement underscores CovarsaDx's clinical expertise and highlights the company's ability to quickly and effectively help bring diagnostic tests from clinical validation to market, improving access to reliable testing.

"As their trusted CRO, we are excited to work with Healgen and ITAP on this groundbreaking advancement," said Chermaen Lindberg, president and CEO of CovarsaDx. "This De Novo marketing authorization is an important milestone in diagnostic testing, enabling better access to detection for improved health outcomes."

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.

Learn more at CovarsaDx.com. Click here for FDA press release.

About CovarsaDx
CovarsaDx is a leading clinical research organization specializing in in vitro diagnostics (IVDs) and medical devices. The company provides agile responses to patient population needs and fluctuations in regulatory requirements for rapid market pathways. Their team of regulatory, quality and clinical experts have extensive industry experience and consist of regulatory strategists, quality experts, study managers, monitors, data managers, and statisticians who work together to deliver reliable clinical results.

Contacts
Media: [email protected]
Study Inquiries: [email protected]

CovarsaDx^® is a registered trademark of CovarsaDx Corporation. Rapid Check^® is a registered trademark of Healgen Scientific, LLC.

SOURCE CovarsaDx