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Epistem Announces Successful External Assessment of Genedrive® Hepatitis C Test
Feb. 18, 2016 08:40AM PST
Biotech Investing
Epistem Holdings Plc (LSE:EHP) announced today that its Genedrive® point of care Hepatitis C (“HCV”) test has successfully completed its first external assessment.
Epistem Holdings Plc (LSE:EHP) announced today that its Genedrive® point of care Hepatitis C (“HCV”) test has successfully completed its first external assessment.
According to the company:
The assessment was conducted on reference material and patient samples at the Institut Pasteur, Paris, and its success allows clinical trials of the HCV test to commence, in anticipation of regulatory approval and market launch in the EU during 2017.
The Genedrive® qualitative HCV test detects viral RNA, covers all HCV genotypes and is performed at “point of need” medical centres directly on plasma without the requirement for complex laboratory equipment or highly trained operators. The test is completed within 90 minutes and has shown excellent alignment to target product profile specifications for HCV, as specified by the Foundation for Innovative New Diagnostics (FIND)1.
Dr Ian Gilham, Chairman of Epistem, commented:
The commencement of clinical trials of our HCV assay is an important step in our ongoing commercialisation of Genedrive®, alongside the introduction of our TB test into the Indian market. The excellent results seen with HCV serve as a key proof of principle of our ability to develop blood-based tests and allow us to proceed with the development of tests for Hepatitis B and HIV, positioning Genedrive® as the point of care platform of choice for the diagnosis of infectious diseases.