- The Diagnostics for Epidemic Preparedness strategy focuses on the need for innovative technical solutions, market sustainability and improved response speed to boost outbreak response
- Grant awarded to altona Diagnostics for the development of an automated Lassa virus assay, in a partnership-based business model that uses Cepheid’s Flex cartridge system, with evaluation to be conducted by the Bernhard Nocht Institute for Tropical Medicine
- Announcement to be made during side event at the 71st World Health Assembly
Geneva, Switzerland – 21 May 2018 – The Foundation for Innovative New Diagnostics (FIND) will announce today, during the 71st World Health Assembly, the award of a grant to pilot a partnership-based business model that pairs assay developers with instrument manufacturers to develop diagnostics for pathogens with outbreak potential. The model is designed to facilitate sustainable, rapid expansion of diagnostic test menus in order to be able to address newly emerging pathogens. For this pilot, FIND has given a grant to altona Diagnostics (Hamburg, Germany), the Bernhard Nocht Institute for Tropical Medicine (BNITM; Hamburg, Germany) and Cepheid (Sunnyvale, USA). The award is the first investment in FIND’s new Diagnostics for Epidemic Preparedness strategy to address diseases with outbreak potential. The strategy focuses on improving diagnostic preparedness by developing enhanced technical solutions, increasing response speed and ensuring market sustainability despite the unpredictability of outbreak situations.
Disease outbreaks are an ever-present threat. Diagnostics are essential to identify the cause of an outbreak and determine its extent so that evidence-based control strategies can be implemented without delay to avoid a global epidemic. Diagnostic surveillance can track the course of an outbreak, monitor trends and assess the impact of control interventions – enabling rapid containment that will minimize the cost of response and, most importantly, save lives. The World Health Organization (WHO) maintains a list of high-priority pathogens that could spark a major international public health emergency – including “Disease X”, an as-yet-unknown pathogen that could pose a future risk. Six of these ten priority pathogens have significant unmet diagnostic needs.
Outbreak-causing pathogens are typically due to resurgence of an existing endemic pathogen. Annual outbreaks of Lassa fever are common in West Africa; in Nigeria alone, over 100 lives have been lost so far this year. FIND is using this specific threat to pilot a partnership-based business model designed to improve market sustainability and response speed.
Through a competitive selection process, FIND has awarded a grant to altona Diagnostics for the development of an automated Lassa virus assay, which will be ported onto a Flex cartridge system that Cepheid is developing for GeneXpert®. Evaluation of this diagnostic solution will be carried out independently by BNITM in both the biosafety level 4 (BSL-4) laboratory in Germany and in collaboration with partner institutions in Nigeria.
“The Ebola and Zika outbreaks have demonstrated the acute needs in diagnostic preparedness and we will only be able to meet these needs if we think differently about how private sector companies can work together in the interest of global health security,” said Catharina Boehme, CEO of FIND. “Novel industry partnerships are key to creating flexible and comprehensive diagnostic solutions that address surveillance and rapid response needs.”
The assay development work is slated to make rapid progress with a prospective goal of running field demonstration studies by as early as the first quarter of 2019.
FIND’s contribution to this initiative is supported by 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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 World Health Organization. List of Blueprint priority diseases, February 2018 http://www.who.int/blueprint/priority-diseases/en/
 World Health Organization. Lassa Fever – Nigeria. Disease outbreak news, 20 April 2018. http://www.who.int/csr/don/20-april-2018-lassa-fever-nigeria/en/