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Epistem diagnostic test cleared for Hepatitis C trials

The Institut’s approval allows clinical trials of the HCV test to commence
Epistem diagnostic test cleared for Hepatitis C trials
Genedrive detects viral RNA, covers all HCV genotypes and is performed at "point of need" medical centres

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Epistem Holdings’ (LON:EHP) genedrive diagnostic test has been cleared for clinical trials in Hepatitis C (HCV) by the Institut Pasteur in  Paris.

The qualitative HCV test was developed in collaboration with Inserm, the French National Institute of Health and Medical Research, under a €6m EU supported programme.

The Institut’s approval allows clinical trials of the HCV test to commence in anticipation of regulatory approval and market launch in the EU during 2017, Epistem said.

Ian Gilham, chairman said: "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." 

Genedrive detects viral RNA, covers all HCV genotypes and is performed at "point of need" medical centres directly on plasma within 90 minutes.

It is also a qualitative test, not a simple yes or no. This ability to measure the viral load is key for physicians as a new range of anti-viral drugs hits the market, said Gilham.

 An estimated 150 - 200mln people are believed to have chronic HCV viral infection with 350,000 deaths each year from related diseases.

Shares rose 7% to 120p.

 

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