Find Explores New Diagnostic Technologies with the Potential to Confirm Hepatitis C Infection in Community Settings

FIND Press Release

• Awards to Novel Biomarkers Catalyst Lab B.V. and Qorvo Biotechnologies, LLC are the latest advances in FIND’s Unitaid-supported Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) programme
• Both companies will receive support to test the feasibility of cartridge-based hepatitis C virus (HCV) core antigen immunoassays for detection of HCV infection, for use in rapid diagnostic tests at the point of care
• Awards follow conclusion of an extensive Request for Proposal process
  

Geneva, Switzerland – 16 November 2018 – 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).¹ 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.²

“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,³ as recommended in the World Health Organization (WHO) guidelines on hepatitis B and C testing.⁴

The feasibility projects are expected to run for 6 months.

These studies form part of a larger FIND programme known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by Unitaid. HEAD-Start builds on earlier work supported by the government of the Netherlands, and UK aid from the UK government.

About Hepatitis C
HCV is one of the world’s most common infectious diseases, usually contracted through unsafe healthcare and injection drug use. Globally, more than 71 million people are chronically infected, over 80% of whom live in low- and middle-income countries (LMICs) – but only one in five people know they have the disease. Around 400,000 people die every year, and the mortality rate is increasing, making it a global health priority: the World Health Organization has set an ambitious target of viral hepatitis elimination by 2030.

About FIND
FIND is a global non-profit organization that drives innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Our work bridges R&D to access, overcoming scientific barriers to technology development; generating evidence for regulators and policy-makers; addressing market failures; and enabling accelerated uptake and access to diagnostics in low- and middle-income countries (LMICs). Since 2003, we have been instrumental in the delivery of 21 new diagnostic tools used in 150 LMICs. Over 38 million FIND-supported products have been provided to our target markets since the start of 2015. A WHO Collaborating Centre, we work with more than 200 academic, industry, governmental, and civil society partners worldwide, on over 70 active projects that cross six priority disease areas. FIND is committed to a future in which diagnostics underpin treatment decisions and provide the foundation for disease surveillance, control and prevention.

¹ EASL Clinical Practice Guidelines for Management of HCV Infection. http://www.easl.eu/research/our-contributions/clinical-practice-guidelines/detail/management-of-hepatitis-c-virus-infection (accessed 12 October 2018)

² Freiman JM, et al. Ann Intern Med. 2016;165(5):345–55.

³ FIND & Forum for Collaborative HIV Research. High-priority target product profile for hepatitis C diagnosis in decentralized settings: report of a consensus meeting, 2015. https://www.finddx.org/wp-content/uploads/2016/01/HCV-TPP-Report_17July2015_final.pdf (accessed 25 July 2018)

⁴ World Health Organization. Guidelines on hepatitis B and C testing: policy brief, 2016. http://www.who.int/hepatitis/publications/hepatitis-testing-recommendation-policy/en/ (accessed 25 July 2018)