- Grants for feasibility studies to be awarded to Abbott, BLINK-DX, and Diagnostics for the Real World for the development of a molecular point-of-care (POC) test for hepatitis C virus (HCV) RNA detection; and Chembio Diagnostics, Mologic and DCN Diagnostics for development of an HCV core antigen rapid diagnostic test
- Grants for development and implementation of country-specific strategies for demand creation and advocacy activities for HCV diagnosis to be awarded to Treatment Action Group (TAG) and Delhi Network of Positive People (DNP+)
- Awards follow conclusion of an extensive Request for Proposal process and announcements coincide with World Hepatitis Day 2018
Geneva, Switzerland – 28 July 2018 – The Foundation for Innovative New Diagnostics (FIND) announced today, World Hepatitis Day 2018, the conclusion of an extensive Request for Proposal (RFP) process to address the urgent diagnostic needs for hepatitis C virus (HCV). Grants will be awarded to conduct feasibility studies of various technologies that could transform HCV testing at the point of care (POC): Abbott, BLINK-DX, and Diagnostics for the Real World will receive support to advance potential HCV RNA tests on a polyvalent, true POC molecular platform, aiming to provide clinically actionable data in lower level health facilities; and Chembio Diagnostics, Mologic and DCN Diagnostics will receive support to develop and validate prototype HCV core antigen (cAg) tests on their innovative rapid diagnostic test (RDT) platforms. In addition to funding, FIND will provide project support including reference samples for assay development, antibodies for capture and detection of HCV cAg, and technical expertise.
This RFP is the result of extensive 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,1 as recommended in the World Health Organization (WHO) guidelines on hepatitis B and C testing.2
Treatment Action Group (TAG) and Delhi Network of Positive People (DNP+) have been awarded grants to develop and implement country-specific strategies for demand creation and advocacy activities on HCV diagnosis and diagnostics in six countries (Cameroon, Georgia, India, Malaysia, Myanmar and Viet Nam). The feasibility studies and the demand creation and advocacy programmes are both part of the Unitaid-funded Hepatitis C Elimination through Access to Diagnostics (HEAD-Start) project.
HCV is one of the world’s most common infectious diseases. It claims the lives of around 400,000 people every year, and the mortality rate is increasing. 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.3 Where they exist, HCV screening and diagnosis remain largely centralized and siloed, especially in LMICs. Sharing unclean needles or other equipment to prepare or inject drugs is one of the most common source of HCV infection, as the virus is usually contracted when blood from a person infected with HCV enters the body of someone who is not infected.4
WHO has set an ambitious target of viral hepatitis elimination by 2030 to support Sustainable Development Goal 3.5,6 Current diagnostic strategies start with screening – a test to identify antibodies that would be present if a person has ever been exposed to HCV, even if the infection has subsequently been cleared spontaneously or cured through therapy. If the screening test is positive, confirmatory testing is needed to establish if the person is still infected with the virus, either through viral load or core antigen testing – neither of which are currently available for use in community settings. A test to detect active infection (known as HCV RNA) determines presence of HCV in the blood, whereas the HCV CAg is a viral protein that is part of the HCV. HCV CAg testing is simpler and less expensive than HCV RNA testing, but it does not detect low levels of HCV (<3,000 IU/mL).7
“Chronic hepatitis C has surpassed HIV as a leading cause of death in many countries, but to achieve WHO elimination targets – and to avoid a potential 2.1 million HCV-associated deaths – it is crucial to increase the number of people who are diagnosed and link them to treatment,” said Catharina Boehme, CEO of FIND. “We need affordable, point-of-care diagnostics, and smart strategies to ensure they reach patients, including integration into existing testing pathways such as HIV care and support services. Without this holistic diagnostic approach, we will not succeed.”
Individual projects are expected to run for a duration of up to 3 years.
This work forms part of a larger FIND programme known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by Unitaid. It builds on earlier work supported by the government of the Netherlands, and UK aid from the UK government.
FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, non-malarial fever and diseases with outbreak potential, such as Ebola. FIND has partnered in the delivery of 20 new diagnostic tools and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has nearly 200 partners globally, including research institutes and laboratories, health ministries and national disease control programmes, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites.
Sarah-Jane Loveday, Head of Communications
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1 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)
2 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)
3 World Health Organization. Global hepatitis report 2017. www.who.int/hepatitis/publications/global-hepatitis-report2017/en/ (accessed 27 June 2018)
4 Centers for Disease Control and Prevention. Hepatitis C Questions and Answers for the Public https://www.cdc.gov/hepatitis/hcv/cfaq.htm (accessed 18 July 2018)
5 World Health Organization. Disease burden and mortality estimates, 2000–2015. http://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html (accessed 27 June 2018)
6 World Health Organization. Combating hepatitis B and C to reach elimination by 2030, May 2016. http://apps.who.int/iris/bitstream/handle/10665/206453/WHO_HIV_2016.04_eng.pdf;jsessionid=0B0881916BBDF9EB2B47D4B004DB7969?sequence=1 (accessed 5 July 2018)
7 Freiman JM, et al. Ann Intern Med. 2016;165(5):345–55.