DCN Dx, a contract research organisation for in vitro diagnostics, has announced that Wondfo USA’s WELLlife Covid-19/Influenza A&B Test received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).
Wondfo USA’s collaboration with DCN Dx through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP) has led to the performance and clinical validation of the WELLlife test in the US.
DCN Dx chief operating officer Pat Vaughan said: “We extend our congratulations to the Wondfo USA team on achieving FDA EUA for the WELLlife test. Their dedication and expertise have culminated in a crucial tool that will positively impact healthcare.”
The authorisation allows healthcare providers to quickly distinguish between Covid-19 and influenza, improving patient outcomes at the point of care.
The test’s rapid diagnostic capabilities are crucial for managing respiratory infections with similar symptoms.
DCN Dx said the NIH’s Rapid Acceleration of Diagnostics (RADx) Tech programme and its ITAP have been instrumental in expediting the regulatory review and availability of high-quality diagnostic tests.
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Wondfo USA’s WELLlife test is designed to allow the qualitative detection and differentiation of influenzas A and B, as well as SARS-CoV-2, from anterior nasal samples.
The rapid diagnostic test is a critical tool for healthcare professionals to manage and treat respiratory virus infections, which often have overlapping clinical presentations.
DCN Dx clinical research vice-president Emily Friedland said: “Our role in the clinical research for the WELLlife test exemplifies our commitment to supporting the development and commercialisation of important diagnostics.
“We are proud to have supported Wondfo USA in the clinical research and validation stages that were crucial for achieving FDA EUA.”
