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
377710@email4pr.com
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SOURCE DCN Dx