DCN Dx has received De Novo marketing authorisation from the US Food and Drug Administration (FDA) for its Cepheid Xpert Hepatitis C Virus (HCV) test.
DCN Dx is an In vitro diagnostic (IVD), contract manufacturing and development organisation (CDMO), and provides contract research organisation (CRO) services.
The California-based company received the marketing nod with Clinical Laboratory Improvement Amendments (CLIA) Waiver for the HCV test.
Cepheid Xpert HCV test, backed by DCN Dx’s clinical research, represents the first-ever capillary whole blood (fingerstick) point-of-care RNA test for HCV.
The test is designed for adults showing signs or symptoms of hepatitis C or those at risk of contracting the virus. It is not meant for monitoring patients undergoing treatment nor for screening blood, plasma, or tissue donors.
It aims to streamline HCV diagnosis and treatment initiation in a single visit, making the test more convenient.
Providing results within one hour, the test reduces the necessity for multiple appointments and enhances the likelihood of patients receiving prompt treatment.
DCN Dx CEO Charlie Mamrak said: “We are honoured to have supported the clinical research that contributed to the NIH-FDA ITAP program and the successful De Novo authorisation of the Xpert HCV test.
“This test will have a profound impact on public health by streamlining HCV diagnosis and treatment.”
The Independent Test Assessment Program (ITAP), part of the National Institutes of Health (NIH) RADx Tech programme in collaboration with the US Food and Drug Administration (FDA), supported the evaluation and authorisation of the test.
ITAP ensures the availability of, accurate, and reliable diagnostic tests to the public by accelerating test evaluation to support the FDA’s regulatory review.
DCN Dx’s clinical research services team collaborated with NIH-FDA ITAP, Cepheid, and clinical sites to ensure timely enrolment, testing, and documentation that verified the clinical performance of this product.
