Development and Commercialisation of a Second Generation Rapid Diagnostic Test (RDT) for Human African Trypanosomiasis (HAT) and other Kinetoplastida
Lead Research Organisation:
University of Kent
Department Name: Sch of Biosciences
Abstract
The overall aim of this research is to complete the further development and commercialisation of new tests for the detection and diagnosis of the parasite Human African Trypanosomiasis (HAT or sleeping sickness), building upon and completing previously funded BBSRC applications. HAT threatens 43.4 million people in the sub-Saharan area of Africa, is the result of infection by parasites transmitted by the tsetse fly, and the development of new, more reliable and economic diagnostic biomarkers and assays is essential, particularly for surveillance and to curb transmission in the remaining moderate to high risk foci. Our approach is also amenable to the development of new diagnostic tests for the diagnosis, monitoring and surveillance of other diseases caused by parasite diseases. We will therefore also apply our technology to the development of new diagnostic tests for other diseases caused by Trypanosomes and Kinetoplastid diseases of commercial and social importance.
People |
ORCID iD |
| Christopher Smales (Principal Investigator) |
Publications
Murphy N
(2020)
Glycosylation of Trypanosoma cruzi TcI antigen reveals recognition by chagasic sera.
in Scientific reports
| Description | We have optimised the development of a rapid diagnostic assay for sleeping sickness that can be used in the field to detect infection with the causative parasite. This test is now undergoing a field trail alongside other potential tests to determine if it offers superior performance. Alongside this we are developing such rapid diagnostic tests for other neglected tropical diseases by generating recombinant antigens, including animal forms of diseases. A key findings is that, by using alternative expression systems to develop antigens for rapid-point-of-care diagnostics, we are able to generate tests for African sleeping sickness that are more sensitive than existing tests. We believe this is due to the nature of the expression system used, whereby the system has the ability to produce post-translational modifications on the antigen that mirror those that the parasite itself would undertake and present to the immune system. The recombinant antigens are therefore more likely to recognised by a persons own antibodies to the parasite that causes sleeping sickness, resulting in a more sensitive test. The work has also now resulted in investigations into development of assays for other neglected tropical diseases with collaborators. |
| Exploitation Route | Currently the tests are undergoing field trial in Africa. If successful this could result in the adoption of our test for sleeping sickness diagnosis and monitoring as a recommended test. These tests will be on-going for several years and are still in process at the time of writing. Both the tests developed within this project, but also the approach of using an alternative expression system to develop antigens tailored to the organism you wish to detect, can be utilised by others in developing new diagnostic tests. One of the commercial partners that worked with us on the project is now looking to further develop and commercialise the expression of the antigen and subsequent test. |
| Sectors | Communities and Social Services/Policy,Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| URL | https://bbsrc.ukri.org/documents/1609-sleeping-sickness/ |
| Description | The rapid diagnostic tests have both a social impact and potentially economic. The rapid diagnostic test developed is currently under clinical field trial to determine the specificity and sensitivity in the filed and how this performs against competitor tests that have been developed. The trial is on-going and we have learnt that a commercial company may now look to develop this commercially further. The work has also been developed into investigating other neglected tropical diseases. The work has helped underpin the launch of the not for profit company Trozon X17. |
| Sector | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Cultural,Societal,Economic |
| Description | Rapid diagnostic for sleeping sickness |
| Geographic Reach | Africa |
| Policy Influence Type | Influenced training of practitioners or researchers |
| Impact | Development of a diagnostic for sleeping sickness and travel of Dr Barrie Rooney to Africa to test for sleeping sickness. Discussion of diagnostics and approaches to develop these and link to treatment and monitoring of population. |
| Title | Diagnostic fo African Sleeping Sickness |
| Description | Rapid point-of-care rapid diagnostic for sleeping sickness. Currently undergoing clinical trail in Africa. |
| Type Of Material | Technology assay or reagent |
| Year Produced | 2016 |
| Provided To Others? | Yes |
| Impact | Awaiting results of trail. |
| Description | Development of diagnostics and treatments for dengue fever |
| Organisation | Mahidol University |
| Department | Faculty of Tropical Medicine |
| Country | Thailand |
| Sector | Academic/University |
| PI Contribution | Development of antibodies to Dengue fever for diagnostics and treatment. Collaborator has contributed knowhow and vectors for antibody sequences and we have generated expression vectors and ability to produce these antibodies in Chinese hamster ovary (CHO) cells. |
| Collaborator Contribution | As above, gene sequences, DNA, plasmids and knowhow around antibodies against dengue fever. |
| Impact | Collaboration between life scientists and clinical scientists. |
| Start Year | 2018 |
| Description | Tropical Institute Collaboration |
| Organisation | Institute of Tropical Medicine Antwerp |
| Country | Belgium |
| Sector | Academic/University |
| PI Contribution | Development of recombinant antigens for rapid diagnostic test for sleeping sickness. |
| Collaborator Contribution | Providing serum and samples to test and validate antigens and diagnostics. |
| Impact | Development of new diagnostic for sleeping sickness that is now in field trial in Africa. |
| Start Year | 2014 |
| Title | A second generation Rapid Diagnostic Test (RDT) for Human African Trypanosomiasis (HAT) |
| Description | Currently in trial in Africa and being tested against other diagnostics to determine if the one developed during this project is superior. |
| Type | Diagnostic Tool - Non-Imaging |
| Current Stage Of Development | Late clinical evaluation |
| Year Development Stage Completed | 2017 |
| Development Status | Under active development/distribution |
| Clinical Trial? | Yes |
| Impact | Outreach and Dr Barrie Rooney awarded BBSRC Social Innovator of year. |
| Company Name | Trozon X |
| Description | The PDRA on the project has developed this spin out project and is the CEO. The aim of TROZON X is to design diagnostics for Tropical Zone Diseases which are easy to use in any environment. |
| Year Established | 2017 |
| Impact | None yet. |
| Website | http://www.trozonx.com |
| Description | 7 open days at University |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Describing the research we undertake in the laboratory, covering all aspects of the research and the impact this has/can have. Particular questions around genetic modification of cells to produce recombinant proteins in all sessions and discussions around both the ethical aspects of this and the potential applications of such technology. |
| Year(s) Of Engagement Activity | 2015,2016 |
| Description | Barrie Rooney spoke on BBC Radio Kent about working in Africa with contagious diseases |
| Form Of Engagement Activity | A press release, press conference or response to a media enquiry/interview |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Public/other audiences |
| Results and Impact | Discussion afterwards. Asked about tropical diseases. |
| Year(s) Of Engagement Activity | 2014 |
| URL | http://www.bbc.co.uk/programmes/p027d7jt |
| Description | Big Bang at Discovery Park |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Regional |
| Primary Audience | Schools |
| Results and Impact | Student and teacher evaluation suggest it was a day of 'awesome activities', 'wonderful activities' and STEM professionals who inspired the students to think they could and they can be successful in STEM'. Teacher feedback suggested that this was the best year yet and that it was a success in meeting the needs of their pupils. |
| Year(s) Of Engagement Activity | 2016,2017,2018,2019 |
| URL | http://www.thestemhub.org.uk |
| Description | Langton MBP project |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Schools |
| Results and Impact | Mentoring and aiding in running of research project at Simon Langton Grammar School for boys to sixth formers. |
| Year(s) Of Engagement Activity | 2019,2020 |
| Description | Open Day talks and lab tours |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Tours of research laboratory, demonstrating of research and talk/presentation on the work that we do. |
| Year(s) Of Engagement Activity | 2019,2020 |
| Description | Open day tours of research laboratory and discussions with participants |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Undergraduate students |
| Results and Impact | 8 days of open day activities. |
| Year(s) Of Engagement Activity | 2017 |
| Description | Outreach Presentation on Diagnostics for Neglected Tropical Diseases |
| Form Of Engagement Activity | Participation in an open day or visit at my research institution |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | Discussions and demonstrations on mass spectrometry analysis of recombinant biotherapeutic proteins and how these are expressed. |
| Year(s) Of Engagement Activity | 2018 |
| Description | Outreach Presentation on Diagnostics for Neglected Tropical Diseases |
| Form Of Engagement Activity | A talk or presentation |
| Part Of Official Scheme? | No |
| Geographic Reach | Local |
| Primary Audience | Public/other audiences |
| Results and Impact | Rotary Club Presentation on Diagnostics |
| Year(s) Of Engagement Activity | 2016 |
| Description | Royal Society Summer Science Exhibition |
| Form Of Engagement Activity | Participation in an activity, workshop or similar |
| Part Of Official Scheme? | No |
| Geographic Reach | National |
| Primary Audience | Public/other audiences |
| Results and Impact | The Summer Science Exhibition is an annual display of the most cutting-edge science and technology in the UK. This free, week-long festival features exhibits and a series of inspiring talks and activities for all ages. Meet the scientists, discover the exciting research and technology they work on and have fun with great hands-on activities. |
| Year(s) Of Engagement Activity | 2018 |
| URL | https://royalsociety.org/science-events-and-lectures/2019/summer-science-exhibition/ |
| Description | Turkey Public Biotechnology Talk |
| Form Of Engagement Activity | A broadcast e.g. TV/radio/film/podcast (other than news/press) |
| Part Of Official Scheme? | No |
| Geographic Reach | International |
| Primary Audience | Public/other audiences |
| Results and Impact | Presentation to public audience in Turkey on behalf of the British Council around biotechnology and its application. Event was filmed and followed by a question and answer session, answering questions sent in before the talk by social media and then from the audience. The event was filmed and shown on national TV in Turkey. Large range of topics discussed around the application of biotechnology to every day life and issues with long discussion/debate. |
| Year(s) Of Engagement Activity | 2016 |
| URL | http://www.britishcouncil.org.tr/en/programmes/education/science-innovation-talks/biotechnology |