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CovarsaDx Supports FDA Clearance for QuickFinder Tests

In a significant milestone for public health, CovarsaDx®, a leading Clinical Research Organization (CRO), announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its QuickFinder™ COVID-19/Flu Antigen Self-Test and QuickFinder™ COVID-19/Flu Antigen Pro Test. This achievement represents a breakthrough in the realm of accessible diagnostics for respiratory infections, including COVID-19 and influenza.

The QuickFinder tests, developed by OSANG Healthcare, allow individuals to detect the presence of SARS-CoV-2, influenza A, and B infections without the need for a prescription. Utilizing simple nasal swabs, these tests can produce results in just 15 minutes, making testing more convenient than ever for everyday users. The QuickFinder™ Self Test is designed for use at home by adults and youth aged 14 and above, while the Pro Test is intended for professional healthcare settings.

Dan Lee, CEO of OSANG Healthcare, emphasized the collaborative effort with CovarsaDx, stating, “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.” This cooperation underscores the importance of rigorous testing and validation in bringing effective healthcare solutions to the market.

CovarsaDx conducted the pivotal studies necessary to support the FDA clearance, showcasing its commitment to advancing diagnostic innovation through tailored clinical research. Chermaen Lindberg, president and CEO of CovarsaDx, highlighted their role: “Our clinical research team specializes in creating tailored, high-quality studies that provide the data necessary to navigate regulatory pathways successfully.” This focus on individualized research and adaptability to regulatory changes exemplifies CovarsaDx's agility within the rapidly evolving healthcare landscape.

The QuickFinder™ Self Test comes with easy-to-follow instructions, allowing users to identify COVID-19 and influenza infections from the comfort of their homes. This accessibility is crucial, especially given the increasing public demand for rapid and user-friendly testing options as we continue to navigate through various respiratory illness outbreaks.

CovarsaDx is not only making strides in this project but is also reflecting its broader mission to enhance diagnostic efficacy through specialized clinical research, regulatory proficiency, and quality services. Their work aims to shorten the path to market for medical devices and diagnostics, ultimately improving patient care.

In addition to this clearance, the ongoing development of similar products showcases OSANG Healthcare’s commitment to innovating health solutions that directly improve patient outcomes. With a robust pipeline of in-vitro diagnostic products, OSANG continues to strive towards its goal of enhancing global health standards.

As the healthcare community embraces these advancements, CovarsaDx and OSANG Healthcare's collaboration is set to redefine how people approach testing for common respiratory infections, providing a significant step forward in public health safety and proactive disease management.

For more information on CovarsaDx and its clinical research services, visit CovarsaDx Website.

About CovarsaDx

CovarsaDx, a prominent Clinical Research Organization (CRO), specializes in in-vitro diagnostics (IVDs) and medical devices. Their experienced team is dedicated to meeting patient population needs and ensuring compliance with evolving regulatory requirements, thus facilitating the swift delivery of life-changing technologies to market.

About OSANG Healthcare

OSANG Healthcare is a leading provider of innovative in-vitro diagnostic products, dedicated to enhancing healthcare through cutting-edge technology and solutions designed to have a significant impact on lives worldwide.