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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