Summary: CovarsaDx, a leader in clinical research for in-vitro diagnostics and medical devices, supported OSANG Healthcare in securing FDA 510(k) clearance for the QuickFinder COVID-19/Flu Antigen Self-Test and Pro Test, providing fast and accurate results for both home and professional use.

Takeaways

  1. FDA Clearance Achieved: The QuickFinder COVID-19/Flu Antigen Tests, designed for home and professional use, can detect SARS-CoV-2, influenza A, and influenza B with results in 15 minutes.
  2. CovarsaDx’s Expertise: CovarsaDx conducted pivotal studies, ensuring the tests met regulatory standards for safety, efficacy, and ease of use.
  3. Consumer and Professional Solutions: The QuickFinder Self Test offers at-home diagnostics for individuals aged 14+ or adults testing children as young as two, while the Pro Test is tailored for healthcare settings.

CovarsaDx, a clinical research organization (CRO) with expertise in the areas of in-vitro diagnostics (IVDs) and medical devices, announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the QuickFinder COVID-19/Flu Antigen Self-Test and QuickFinder COVID-19/Flu Antigen Pro Test.

CovarsaDx, on behalf of test manufacturer OSANG Healthcare, conducted key studies necessary to support the clearance.

FDA-Cleared COVID and Flu Testing

These tests provide a solution for detecting SARS-CoV-2, influenza A, and influenza B antigens without a prescription using simple nasal swab specimens and provide results within 15 minutes.

“CovarsaDx’s clinical research expertise was instrumental in designing and executing the studies needed to validate the QuickFinder tests, ensuring they are safe, effective, and easy-to-use diagnostic tools,” says Dan Lee, CEO of OSANG Healthcare. “Working with this dedicated team was a seamless and collaborative experience, and their commitment to quality and precision was invaluable in achieving this milestone.”

The QuickFinder Self Test is indicated for home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older. With clear, step-by-step instructions, users of the test can identify COVID-19 and influenza respiratory infections, from the comfort of their homes. The QuickFinder Pro Test will be marketed for professional use in health care settings. 

“Our clinical research team specializes in creating tailored, high-quality studies that provide the data necessary to navigate regulatory pathways successfully,” says Chermaen Lindberg, president and CEO of CovarsaDx. “We are proud to have partnered with OSANG Healthcare in bringing this consumer-friendly diagnostic tool to market.”

This achievement highlights CovarsaDx’s commitment to advancing diagnostic innovation through its specialized clinical research, regulatory and quality services, offering tailored solutions to accelerate product development and regulatory approval.