Hepatitis C Diagnostics Technology Landscape

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The World Health Organization (WHO) estimates that in 2015, there were 1.75 million new hepatitis C virus (HCV) infections, bringing the total number of infected people to 71 million globally.

Although generic versions of direct acting antivirals (DAAs) are now available in low income settings, the use of DAAs is still limited. It is hoped that the wider availability of DAAs will continue to reduce the cost and complexity of the HCV testing continuum, and reduce adverse events, ultimately improving patient outcomes.

Companies are still developing and improving methods to diagnose, genotype and monitor HCV viral load and as more diagnostic tests/platforms are introduced, it is hoped that access to testing for HCV patients, from screening through to cure, will be improved further. It is also important to highlight the nucleic acid-based/nucleic acid amplification tests (NATs) that are in development for a range of infectious diseases, for use at or near the point of care (POC), without the requirement for expensive laboratory infrastructure. These, in particular, promise to expand access to testing. In addition, there is a significant effort to develop HCV core antigen (HCV cAg) assays that could be used at the POC, and that could potentially be carried out effectively at a lower cost than NAT POC tests.

This report examines the range of platforms/tests currently available for HCV testing, from screening, to confirmation and genotyping, fibrosis staging and treatment monitoring. Finally, it reviews the progress of the pipeline of  ests/platforms for HCV that are planned to be delivered at, or near, the POC.