FIND and SAMRC team up to tackle childhood tuberculosis diagnosis

Cape Town, South Africa & Geneva, Switzerland – 23 March 2018 – The South African Medical Research Council (SAMRC) and the Foundation for Innovative New Diagnostics (FIND), today announced a new agreement to support diagnostic innovation for childhood tuberculosis (TB) in South Africa. The project is part of a global effort to improve childhood TB diagnosis, guide paediatric treatment, and reduce suffering, disease transmission and deaths from TB in babies and children.

At least 1 million children 15 years old or younger become ill with TB every year, and 250,000 children die from infection.[1] Childhood TB is a neglected disease and innovations that are available to adults often take years to be made available to children. TB is particularly difficult to diagnose in children as the most commonly available tests are done on sputum, which many children cannot produce. Furthermore, children often have disease with few bacteria, so tests need to be extremely sensitive to detect them. TB in children is usually diagnosed from samples that are obtained with invasive procedures and with methods that take weeks to provide a result and are only available in few laboratories. This leads to delayed therapy, suffering and – too frequently – death.

Proof of principle studies have shown that Cepheid’s Xpert Ultra assay (a sensitive molecular test) can be performed on easily accessible stool samples. In partnership with Rutgers University, the University of Cape Town and product development consultancy 42 Technology, in a project also being supported by the United States National Institute of Allergy and Infectious Diseases, FIND is developing a disposable Stool Processing Kit (SPK) that can be used as an accessory to molecular TB tests such as the Xpert Ultra assay, enabling simple processing of stool specimens from babies and children.

Today’s announcement brings this life-saving technology to South Africa. SAMRC will provide funding to support the South Africa arm of clinical trials for the SPK, which will be conducted in collaboration with the National Health Laboratory Services, Stellenbosch University and the University of Cape Town.

Additional clinical data in settings of intended use is necessary to support development of recommendations by international (e.g. the WHO) and national bodies, which is necessary for uptake into public sector health facilities in low- and middle-income countries (LMICs).

“South Africa has one of the highest burdens of TB globally, but is also at the forefront of testing and successfully deploying innovative TB solutions,” said Professor Glenda Gray, President & CEO of the SAMRC. “This programme is an opportunity to bring that innovation to one of our most vulnerable populations – children with TB.”

“South African institutions have long been strong partners of ours,” said Dr Catharina Boehme, CEO of FIND. “Working with SAMRC on this important project will bring the benefit of South African innovation to babies and children with TB around the world.”

FIND is partnering with Lifeassay Diagnostics, a Cape Town-based biotechnology company specialising in diagnostics for diseases prevalent in LMICs, on SPK manufacturing and scale-up, pending successful clinical evaluation.

This announcement follows the signing of a Memorandum of Understanding between FIND and SAMRC in January 2018, pledging a commitment to identify collaborative opportunities for joint research, development, manufacturing, introduction and scale-up of innovative health technologies and programmes that result in the reduction of mortality and morbidity due to antimicrobial resistance and TB.

Research reported in this press release is supported by the South African Medical Research Council with funds received from the South African National Department of Health. FIND’s contribution to this initiative is supported by The ELMA Foundation, Bill & Melinda Gates Foundation, German government, Australian government and UK aid from the UK government.

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About the South African Medical Research Council (SAMRC)
The scope of the SAMRC’s research includes basic laboratory investigations, clinical research and public health studies. Research at the SAMRC focuses on the following top 10 causes (www.samrc.ac.za) of death in South Africa. To assist with delivering on this vital mandate, the organisation is led by the National Department of Health, and works with other key stakeholders such as the Department of Science and Technology, South African and international science councils, medical schools, universities, research institutions and international collaborators.

About FIND
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.

[1] WHO. Childhood TB. http://www.who.int/tb/areas-of-work/children/en/