FDA Grants EUA to Wondfo’s WELLlife™ COVID-19/Influenza A&B Test Supported by DCN Dx Clinical Research

CARLSBAD, Calif., May 15, 2024 /PRNewswire/ — DCN Dx, a leading contract research organization for in vitro diagnostics, today acknowledges the FDA’s Emergency Use Authorization (EUA) of the WELLlife™ COVID-19/Influenza A&B Test, developed by Wondfo USA. This important authorization will enable healthcare professionals to differentiate rapidly between COVID-19 and influenza infections, enhancing patient care at the point-of-care.

The National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program established the Independent Test Assessment Program (ITAP) to accelerate regulatory review and availability of high-quality, accurate, and reliable diagnostic tests. Through the NIH ITAP program, Wondfo USA collaborated with DCN Dx to conduct performance and clinical validation within the United States.

“We extend our congratulations to the Wondfo USA team on achieving FDA EUA for the WELLlife™ test,” said Pat Vaughan, Chief Operating Officer at DCN Dx. “Their dedication and expertise have culminated in a crucial tool that will positively impact healthcare.”

“Our role in the clinical research for the WELLlife™ test exemplifies our commitment to supporting the development and commercialization of important diagnostics,” said Emily Friedland, VP of Clinical Research. “We are proud to have supported Wondfo USA in the clinical research and validation stages that were crucial for achieving FDA EUA.”

The WELLlife™ test, developed by Wondfo USA, allows for the qualitative detection and differentiation of influenza A, influenza B, and SARS-CoV-2 using anterior nasal samples. This rapid diagnostic capability is vital for managing and treating respiratory virus infections, which often present with similar symptoms.

About DCN Dx

DCN Dx, based in Carlsbad, California, is a global leader in IVD CDMO and CRO services. Our multidisciplinary team specializes in creating tailored assay systems, consumables, and instruments for point-of-use applications, with a particular expertise in lateral flow assays.

Our personalized approach to IVD product development has supported more than 650 programs from 300 clients. We can oversee every stage from concept to assay development and platform integration, through clinical trials to manufacturing or only handle the aspects you request. In addition to lateral flow assays, our clinical research expertise extends to a wide range of IVD devices, all with a focus on innovation, usability, and performance.

With a commitment to quality, customer satisfaction, and industry-leading expertise, DCN Dx is setting the benchmark for excellence in IVD services. To learn more about how we can support your diagnostic needs, visit dcndx.com.

About Wondfo USA Co., Ltd.
Wondfo is a national high-tech enterprise focusing on the research, development, production, sales, and service of point-of-care testing (POCT) products. As one of the leading POCT companies in China, Wondfo Biotech’s diagnostic products are sold in more than 140 countries and regions, and are widely used in various settings, including clinical testing, critical care medicine, primary care, epidemic monitoring, disaster rescue, on-site law enforcement, and family health management. With a strong commitment to innovation and quality, Wondfo USA aims to make significant contributions to the global healthcare industry.

For more information contact:
Mitzi Rettinger
Chief Revenue Officer, DCN Dx
Main: (760) 804-3886
Mobile: (512) 431-5836