LOS ANGELES, Jan. 21, 2025 /PRNewswire/ -- CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in-vitro diagnostics (IVDs) and medical devices, proudly announced today that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the QuickFinder™ COVID-19/Flu Antigen Self-Test (Self Test) and QuickFinder™ COVID-19/Flu Antigen Pro Test (Pro Test). CovarsaDx, on behalf of test manufacturer OSANG Healthcare, conducted key studies necessary to support the clearance.
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,” said 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,” said 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.
For more information about CovarsaDx and their clinical research services, visit https://covarsadx.com.
About CovarsaDx
CovarsaDx is a prominent Clinical Research Organization (CRO) specializing in the area of 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, enabling clients to bring life-saving technologies to market efficiently.
About OSANG Healthcare
Osang Healthcare is a leading provider of in-vitro diagnostic products and services, committed to improving global health through innovation and technology. With a global footprint and a diverse product portfolio, Osang continues to advance healthcare solutions that make a meaningful difference in people’s lives.
CovarsaDx is a registered trademark of CovarsaDx Corporation. QuickFinder is a trademark of Osang LLC.
Contacts:
Media: media@covarsadx.com
Study Inquiries: studies@covarsadx.com
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SOURCE CovarsaDx
