New, more sensitive test is easier to manufacture at scale
LIVINGSTONE, ZAMBIA – 12 September 2017 – Standard Diagnostics, Inc. (SD)/Alere, a global leader in rapid diagnostics, and FIND, a global non-profit dedicated to supporting the development and delivery of diagnostics for poverty-related diseases, announced today the commercial launch of a new rapid diagnostic test (RDT) for human African trypanosomiasis (HAT), also known as sleeping sickness, at the 34th General Conference of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC).
Development of this new RDT was supported by the Bill & Melinda Gates Foundation, UK aid from the UK government and the Swiss Government to accelerate the elimination of sleeping sickness.
The new test, SD BIOLINE HAT 2.0, is an immunochromatographic rapid test that detects antibodies against Trypanosoma brucei gambiense, the parasite responsible for more than 98% of sleeping sickness cases. It will facilitate screening for gambiense HAT patients and contribute to current efforts to eliminate this devastating disease, which causes a severe burden on the socio-economic development of some of the most impoverished communities in 24 sub-Saharan African countries.
The simple test can be performed by health workers with minimal training, using fresh blood from a finger prick, and results are obtained after only 15 minutes. The RDT can be stored at ambient temperature and does not require specialized equipment or electricity, which allows for it to be used in remote and resource-limited settings, where HAT patients are found.
FIND previously collaborated with SD/Alere to support the development of the first RDT for HAT (SD BIOLINE HAT), which has already been introduced in at least 17 endemic countries. The SD BIOLINE HAT test will continue to be available along with the new SD BIOLINE HAT 2.0 test. While these two tests have a comparable diagnostic performance, using them together might be considered in order to further enhance the sensitivity of diagnostic algorithms.
Unlike the first HAT RDT, the SD BIOLINE HAT 2.0 test is made using recombinant parasite antigens, which makes its production easier to standardize, control and scale up. It is now available at a price of USD 0.50 per test (ex works). The new test includes two antigens that were developed in partnership with the University of Dundee and the University of Cambridge (United Kingdom).
“FIND’s role in supporting the development of the new HAT screening test has included the selection of candidate antigens, collection of clinical samples and conducting clinical trials,” explained Dr Catharina Boehme, Chief Executive Officer of FIND. “Today, we are thrilled to announce the launch of this new test, which will facilitate diagnosis of sleeping sickness patients in even the most remote corners of affected countries, and enhance the prospects of achieving and sustaining elimination of the disease.”
“This test is the fruit of several years of joint efforts, and a major achievement resulting from the successful partnership that has been established with FIND to support the development of rapid tests for diseases associated with poverty. We are very proud to be part of the global efforts underway towards meeting WHO’s goal to eliminate HAT as a public health problem by 2020,” said Dr Byung-Ki Cho, General Manager of Standard Diagnostics, Inc. and Vice President of Asia Pacific Operations of Alere.
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.
About Standard Diagnostics, Inc./Alere
Standard Diagnostics, Inc. (SD), an Alere company, is based in the Republic of Korea and focuses on rapid diagnostics.
Alere Inc. delivers reliable and actionable information through rapid diagnostic tests, resulting in better clinical and economic healthcare outcomes globally. Headquartered in Waltham, Massachusetts, Alere focuses on rapid diagnostics for infectious disease, cardiometabolic disease and toxicology. For more information on Alere, please visit www.alere.com.
This press release contains forward-looking statements within the meaning of the United States securities laws, including statements regarding the anticipated impact of the potential product. These statements reflect current views with respect to future events and are based on current assumptions and information currently available. Actual results may differ materially due to numerous factors including the risks described in Alere’s most recent Annual Report on Form 10-K, as amended, which is available on Alere’s website at http://www.alere.com/ww/en/investor-relations/sec-filings-and-financials.html. The parties undertake no obligation to update any forward-looking statements contained herein.
|FIND: Sylvain Biéler, Senior Project Manager
Tel. +41 22 710 27 81
|Alere: Jackie Lustig, Senior Director, Corporate Communications
Tel. +1 (781) 314-4009
- University of Dundee: New diagnostic test for human African sleeping sickness
- University of Cambridge: Cambridge researchers help develop new diagnostic test for African sleeping sickness
- Performance of the SD BIOLINE® HAT rapid test in various diagnostic algorithms for gambiense human African trypanosomiasis in the Democratic Republic of the Congo. Lumbala C, Bessell PR, Lutumba P, Baloji S, Biéler S, Ndung’u JM, PLoS ONE, July 2017.
- French press release: Alere et FIND lancent un test de diagnostic rapide de deuxième génération pour la maladie du sommeil [PDF]