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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.”

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