Multinational Research Team Granted Eight Million Euros to Help Reduce Burden of Parasitic Disease in African Countries

Sensitivity of CytoFLEX Flow Cytometer Delivers Advanced Research Tool

(Miami, Florida - May 13, 2020) The sensitivity of Beckman Coulter Life Sciences’ CytoFLEX Flow Cytometer is underpinning a pioneering multinational research initiative. This is designed to transform the lives of those suffering from a disfiguring and potentially life threatening parasitic disease.

The research team has just secured a grant of eight million Euros from the European & Developing Countries Clinical Trials Partnership (EDCTP), a program supported by the European Union*. Part of this will be used to evaluate the immune status of people suffering from a disfiguring type of leishmaniasis, caused by a tiny single-celled parasite. Leishmaniasis primarily affects people in South America, East Africa and Asia, especially those weakened by malnutrition and poverty.

The project is coordinated by the European Vaccine Initiative and includes researchers from Ethiopia, Kenya, Sudan and Uganda as well as the UK. It is led by Prof. Paul Kaye, a global expert in tropical diseases and based at the Hull York Medical School at the UK’s University of York. Prof. Kaye has developed a new therapeutic vaccine which it is hoped will boost immunity. A prototype is currently being tested in Sudan and will also be evaluated by the research project.

Prof Kaye explained: "To do this successfully, we had to identify better ways of evaluating blood cells in a robust and standardized manner and also be able to carry this out at different research laboratories across East Africa." They therefore needed to find a technologically advanced tool, sensitive enough to support the research aims of identifying rare cell populations, even those with low levels of surface marker expression.

In collaboration with Dr. Peter O’Toole, Director of the University of York’s internationally renowned Imaging and Flow Cytometry Centre, they found the solution in the CytoFLEX, Beckman Coulter Life Sciences’ research flow cytometer, which uses avalanche photodiode detection to achieve the sensitivity required.

Prof Kaye went on: "Our first step was to find a highly sensitive, blood testing system, based on flow cytometry technology, which was easy for less experienced staff to use and straightforward to maintain. As well as being able to test samples quickly, researchers also had to be confident in the reproducibility of their results, so that they were able to identify the same cell types wherever their laboratory was located. This required both the right equipment and well-trained staff."

The project wanted to lay down a technological framework which would support other scientists in East Africa, encouraging the expansion of their discovery research. "By demonstrating the high speed, analytical power of modern flow cytometry, and training others in its use, we hope to open up research possibilities for other African colleagues," added Prof Kaye.

New Flow Cytometry Centre of Excellence for East Africa

Dr. O’Toole established York’s Imaging and Flow Cytometry Centre 17 years ago and it has become a leading center for flow cytometry training and expertise, working with global healthcare companies and pioneering researchers.

Using his expertise and that of project coordinator Dr. Karen Hogg, they have set the ambitious task of establishing a flow cytometry Centre of Excellence in East Africa. "Right from the start, we wanted to create a nucleus of highly skilled flow cytometer experts to look after this investment and able to foster further local research and training in their own countries," said Dr. O’Toole. "This would benefit research not only on leishmaniasis but many other infectious and non-communicable diseases."

Along with Dr. Hogg, they have already run an initial training course, providing high level data analysis skills and instrument maintenance to a group of newly appointed flow managers from each partner country. As part of this, new CytoFLEX instruments have been located at each partner site.

Dr. O’Toole also explained the importance of reproducibility of results. "For research programs on neglected diseases, every penny counts - and in multi-center studies, comparability of data is paramount to success. This would simply not be possible without having access to such an easy to use and compact instrument like the CytoFLEX. It is capable of sophisticated and detailed analysis even when working with only small volume samples and across different labs."

Beckman Coulter’s own data indicates that a significant amount of time spent on preparing the antibody cocktails in flow cytometry labs is wasted due to manual errors, spillage and stock control mistakes. It estimates that an average 25% of the reagents used in a lab are wasted1 .

In African labs, it is especially important that reagent antibody supplies can be stored and transported at normal temperatures without needing refrigeration. Dr. Hogg added: "With the CytoFLEX platform we have the opportunity to replace liquid antibodies with standardized panels of dry, pre-formulated reagents. This makes it easier to reproduce results and ensure accuracy. It also means less preparation time, with our partner labs able to reduce the inevitability of waste, whilst decreasing variability and errors due to human handling."

Samuel Boova, Beckman Coulter Life Sciences’ Director Alliance Development, High Burden Markets, commented: "The prevalence of leishmaniasis continues to rise, having a devastating economic impact on some of the poorest countries in the world, already struggling with high burden of disease. Robust research programs are vitally needed if we are to discover ways to improve life expectancies and the quality of life of such vulnerable people.

"Scientists such as Prof Kaye and Dr. O’Toole recognize the sensitivity and power of the CytoFLEX, even though it is a relatively small device. The way it uses fiber optics was first seen in the telecommunications industry and we are the only company to enlist the power of avalanche photodiode detection in a flow cytometer to deliver such detailed immunophenotyping data.

"By training researchers to accurately understand and interpret the analysis, they and their colleagues will have access to accurate and significant information to further this vital research program."

APPENDIX:

*grant number RIA2016V-1640 – PREV_PKDL.

1 Rajab A, Axler O, Leung J, Wozniak M, Porwit A. Ten- color 15-antibody flow cytometry panel for immunophenotyping of lymphocyte population. International Journal of Laboratory Hematology 2017 May;39 Suppl 1:76-85. doi: 10.1111/ijlh.12678.

Leishmaniasis - https://www.who.int/en/news-room/fact-sheets/detail/leishmaniasis
The World Health Organization (WHO) identifies leishmaniasis as a neglected tropical disease for which new treatments are vitally needed. It is caused by a parasite in the bite of a sand-fly and is endemic in almost 100 countries. Between 20,000 to 30,000 deaths and 700,000 to one million new cases are reported each year. Forced displacement in conflict areas encourages its spread, with tourists and military forces of Western governments based in those countries also at risk

European & Developing Countries Clinical Trials Partnership (EDCTP) - http://www.edctp.org/
The EDCTP funds clinical research to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials.

European Vaccine Initiative (EVI ) - http://www.euvaccine.eu/portfolio/project-index/prev_pkdl
EVI is a non-profit organization dedicated to developing effective, accessible, and affordable vaccines for diseases of poverty and emerging infectious diseases. Through promoting innovative solutions for disease control involving their global partner network of partners, EVI is striving for a world free of the intolerable burden of diseases of poverty within the coming decades. Since its inception in 1998 EVI has contributed to the development and clinical assessment of more than 30 different vaccine preparations. EVI operates with support from the European Commission, the European & Developing Countries Clinical Trials Partnership (EDCTP), the Innovative Medicines Initiative (IMI), the Global Health Innovative Technology Fund (GHIT), the Coalition for Epidemic Preparedness Innovations (CEPI) and others. EVI is hosted by Heidelberg University in Germany.

Hull York Medical School - https://www.hyms.ac.uk/YORK
HYMS is a joint partnership between the University of York and the University of Hull. Established in 2003, it has a reputation as one of the UK's most exciting, contemporary medical schools. The impact of its research is felt not only in the UK, but internationally. Not only does it provide exceptional medical education, centered on professional learning, but clinical and communication skills and early, sustained clinical exposure.

Prof. Paul Kaye - https://www.york.ac.uk/biology/research/infection-immunity/kaye/
Paul Kaye is Professor of Immunology at the University of York. He has worked for over 30 years on the immunology and immunopathology of the neglected tropical disease leishmaniasis. He is internationally recognized for his research on macrophages and dendritic cells, contributing to a fundamental understanding of their biology in health and disease, and for his work on lymphoid tissue remodeling and granulomatous inflammation during chronic infection. Paul is a Welcome Trust Senior Investigator and an elected Fellow of the UK Academy of Medical Sciences. His research tackles leishmaniasis from a holistic viewpoint, rooted in the immunology of the host-parasite interaction, but employing tools and approaches spanning mathematics, ecology, vector biology and neuroscience. He is currently leading a Phase II therapeutic vaccine trial in Sudan and developing a digital pathology platform to facilitate a greater understanding of disease pathogenesis through data sharing and collaboration across geographic borders. The Imaging and Cytometry Laboratory, University of York www.york.ac.uk/biology/technology-facility/imaging-cytometry/

Dr. Peter O'Toole - An expert in fluorescence imaging and flow cytometry, Dr O’Toole established York’s Imaging and Cytometry Laboratory 17 years ago and now directors the overall Bioscience Technology Facility. Under his leadership, it has become one of Europe’s leading centers, bridging the gap between science and commerce. By fostering collaborations and consultancies with external organizations and companies, the center plays a key role in influencing the direction of future commercial systems. Peter holds multiple key positions with different organizations. He is Vice-President of the Royal Microscopical Society, executive committee member for the Core Technologies for Life Sciences, committee member of Flow Cytometry UK and a member of European Light Microscopy Initiative steering committee.

Dr. Karen Hogg - As experimental Officer in the Department of Biology's Imaging and Cytometry Technology Laboratory, she advises manufacturers and users from all over the world and has trained over 1000 experts from over 30 different countries. In 2016, she was awarded the inaugural Royal Microscopy Society (RMS) Medal for Flow Cytometry for her outstanding achievements applying flow cytometry in Life Sciences in fields from immunology to cell biology, bacteriology to plant studies.