FIND explores new diagnostic assays for confirmatory HCV diagnosis in community settings

The Foundation for Innovative New Diagnostics (FIND) today announced awards to support the development, manufacture and feasibility testing of two prototype hepatitis C virus (HCV) core antigen (cAg) immunoassays for confirmatory HCV diagnosis at the point of care (POC). Qorvo Biotechnologies, LLC and Novel Biomarkers Catalyst Lab B.V. (NBCL) will each receive funding to develop prototype cartridge-based HCV cAg assays and assess their performance based on their respective platforms: Qorvo’s proprietary investigational Bulk Acoustic Wave (BAW) technology, and NBCL’s proprietary technology based on the use of paramagnetic particles and chemiluminescent detection. FIND will also provide project support including reference samples for assay development, antibodies for capture and detection of HCV cAg, and technical expertise.

Where they exist, HCV screening and diagnosis remain largely centralized and siloed, especially in low- and middle-income countries (LMICs). Following a positive screening test, confirmatory testing – currently only available in a laboratory – is needed to establish if the person is still infected with HCV. HCV cAg testing could be an attractive alternative to HCV RNA detection, and an HCV cAg assay is already recommended by the European Association for the Study of the Liver (EASL). However this test is only available in centralized laboratories. An HCV cAg POC test is likely to be a cheaper alternative to HCV RNA detection technologies, and can be potentially used as a single-step diagnosis for chronic HCV infection in high-prevalence settings, streamlining the HCV cascade of care and reducing loss to follow up.

“Four out of 5 people living with HCV don’t know they are infected, and fewer than 1 in 10 have been treated. Simplifying the HCV diagnostic algorithm so that a confirmed result can be obtained on the spot is essential if we are going to change these sobering numbers and enable patients to begin the treatment they need as soon as possible,” said Catharina Boehme, CEO of FIND. “For that we need accurate, affordable, point-of-care tests that can be administered in community settings without the need for highly trained lab staff.”

This announcement represents a second and final wave of awards following the conclusion of an extensive Request for Proposal (RFP) process that concluded earlier this year. The RFP was the result of wide-ranging consultations that FIND conducted with multiple stakeholders, resulting in the development of a target product profile (TPP) that has the main goal of facilitating the decentralization of differentiated HCV care and treatment services, as recommended in the World Health Organization (WHO) guidelines on hepatitis B and C testing.

The feasibility projects are expected to run for 6 months.