Clinical Research Efforts Supported by NIH-FDA's ITAP Program
and Facilitate De Novo Authorization
CARLSBAD, Calif., July 10,
2024 /PRNewswire/ -- DCN Dx, a global leader in IVD
CDMO and CRO services, is proud to amplify the news that the U.S.
Food and Drug Administration (FDA) has granted De Novo marketing
authorization with Clinical Laboratory Improvement Amendments
(CLIA) Waiver for the Cepheid Xpert HCV test. The press release
announcing the news is available on the FDA's website here.
This groundbreaking test, supported by DCN Dx's clinical
research, is the first capillary whole blood (fingerstick)
point-of-care RNA test for Hepatitis C Virus (HCV), designed to
enable HCV diagnosis and initiation of treatment in a single visit.
This innovation simplifies the testing process and provides results
within one hour, reducing the need for multiple appointments and
increasing the likelihood of patients receiving timely
treatment.
The Independent Test Assessment Program (ITAP), a National
Institutes of Health (NIH) RADx Tech program in collaboration with
the FDA, played a crucial role in the evaluation and authorization
of the Xpert HCV test. NIH-FDA ITAP program was launched to
accelerate test evaluation to support the FDA's regulatory review
and the availability of high-quality, accurate, and reliable
diagnostic tests to the public.
DCN Dx's clinical research services team worked closely with
NIH-FDA ITAP, Cepheid, and the many participating clinical sites to
ensure timely enrollment, testing, and documentation that
established the clinical performance for this urgently needed
product.
"We are pleased to receive FDA authorization for the Xpert HCV
test," said Scott Campbell, PhD,
Senior Vice President Quality, Regulatory, and Clinical Affairs at
Cepheid. "DCN Dx's clinical research and the NIH-FDA ITAP program's
support were crucial in achieving this milestone, demonstrating the
value of effective collaboration in public health initiatives."
"Congratulations to Cepheid on this remarkable achievement,"
said Charlie Mamrak, CEO of DCN Dx.
"We are honored to have supported the clinical research that
contributed to the NIH-FDA ITAP program and the successful De Novo
authorization of the Xpert HCV test. This test will have a profound
impact on public health by streamlining HCV diagnosis and
treatment."
"Our team is dedicated to advancing diagnostic solutions that
improve patient care," said Emily
Friedland, VP of Clinical Research at DCN Dx. "We are proud
to have played a role in bringing this innovative test to
market."
About DCN Dx
DCN Dx, based in Carlsbad,
California, is a global leader in IVD CDMO and CRO services.
Our multidisciplinary CDMO excels in creating tailored assay
systems, consumables, and instruments for point-of-use
applications, with particular expertise in lateral flow assays. Our
clinical research services group can plan, execute, and oversee
clinical trials for any IVD device, including clinical operations,
data management, and biostatistics.
To learn more about how we can support your diagnostic needs,
visit dcndx.com.
For more information contact:
Mitzi Rettinger
Chief Revenue Officer, DCN Dx
Main: (760) 804-3886
Mobile: (512) 431-5836
380172@email4pr.com
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SOURCE DCN Dx