The first rapid test to screen for sleeping sickness is launched

Kinshasa, DRC – 6 December 2012 – FIND and Standard Diagnostics, Inc. of the Republic of Korea, announced today the launch of the first rapid test to screen for sleeping sickness– a deadly parasitic disease also known as human African trypanosomiasis (HAT).

The announcement was made at a workshop hosted by the Ministry of Health in Kinshasa, Democratic Republic of the Congo (DRC). The new test, named SD BIOLINE HAT, has been developed using parasite antigens provided by the Institute of Tropical Medicine in Belgium under a materials transfer agreement with FIND.

The test has the potential to dramatically change the way the disease is managed by bringing cheap, easy and rapid testing to HAT patients who often live in remote, rural settings with minimal health infrastructure. Clinical trials have recently been completed in Angola, the DRC and the Central African Republic, where data obtained from more than 14,000 individuals confirmed the excellent performance of the test.

“This important milestone brings us one step closer to the elimination of sleeping sickness, as the new rapid test is expected to significantly facilitate diagnosis and therefore speed up identification of patients suffering from this crippling disease”, said Philippe Jacon, Chief Executive Officer of FIND.

Sleeping sickness is a deadly, neglected tropical disease transmitted by the bite of the tsetse fly and affects impoverished rural communities in sub-Saharan Africa. About 70 million people in 36 countries are thought to be at risk. There are no clinical signs that are characteristic of the disease, which makes it difficult to diagnose. If infected people are not treated, they eventually die. Diagnosis of sleeping sickness is done by demonstrating parasites in either blood, cerebrospinal fluid (CSF) or lymph node aspirates using microscopy, which is not easy to perform in screening programmes. Development of a rapid test for trypanosomiasis that detects antibodies to infection, such as the one launched today, has been hindered by the ability of the parasite to keep changing its surface antigenic coat, which allows it to evade the host’s defence mechanisms.

“We urgently need simple and cheap screening tools to detect sleeping sickness, especially in our country, which has the largest proportion of all reported cases in Africa. More practical field-applicable tests that can be used in remote settings will greatly enhance our surveillance and control activities. We are very pleased about the news of this important achievement.” commented Dr Félix Kabange Numbi Mukwampa, Minister of Health of the Democratic Republic of the Congo.

The new test is an immunochromatographic rapid test that detects antibodies against Trypanosoma brucei gambiense, the parasite responsible for more than 90% of sleeping sickness cases. This cheap and very simple-to-use test can be performed by health workers with minimal training, using fresh blood from a finger prick, and the results are obtained after only 15 minutes. The test is unlike any screening tools in use today, as it is stored at ambient temperature and does not require specialized equipment or electricity, meaning that it can thus be used in very remote settings where most of the infected people are found. This will also be the first-ever test for sleeping sickness to be CE marked and to be manufactured by an industrial company following ISO 13485:2003 quality requirements.

“We are committed to continuously develop new rapid tests, always ensuring that neglected tropical diseases such as HAT are amongst our highest priorities. Today, SD is very proud to announce the launch of the first rapid diagnostic test for HAT, which we believe will revolutionize control of the disease. Even though this is a great achievement for us, we look at it as a starting point, as more tests for HAT and for other neglected tropical diseases are and will continue to be in our pipeline”, said Dr. Byung-Ki Cho, Chief Executive Officer of Standard Diagnostics, Inc.

Development of the rapid test for sleeping sickness has been a joint effort of FIND and numerous partners, among them the Institute of Tropical Medicine (Belgium), MicroCoat Biotechnologie GmbH (Germany), the International Livestock Research Institute (Kenya), the Institute of Tropical Neurology (France), Médecins sans Frontières (Spain), the National HAT Control Programme of the DRC (PNLTHA, Democratic Republic of the Congo), the Centrafrican Institute of Agronomical Research (Central African Republic), the World Health Organization and Standard Diagnostics, Inc. (Republic of Korea). This work is supported mainly by the Bill and Melinda Gates Foundation and the Department for International Development (DFID) of the United Kingdom.

About human African trypanosomiasis, HAT
Sleeping sickness is a deadly, neglected tropical disease that affects impoverished rural communities in sub-Saharan Africa. The clinical signs observed are not characteristic of the disease, which makes it difficult to diagnose, and if infected people are not treated, they eventually die. It progresses from an early or stage 1 disease to a devastating 2nd or late stage form associated with damage to the central nervous system. During this 2nd stage, patients display a range of psychotic signs that lead to stigmatization by their families and communities. The few drugs that are used to treat patients in this stage are administered over prolonged periods of hospitalization, and are associated with potentially fatal adverse reactions.

About FIND
The Foundation for Innovative New Diagnostics (FIND) is a not-for-profit international organization dedicated to supporting the development of affordable, easy-to-use, cutting edge diagnostic tests that save lives in the poorest areas of the world. From proof of concept to putting new tests into practice, the organization works with multiple and diverse groups, such as academia, industry, donors, partners in the field, Ministries of Health and the World Health Organization. In addition to HAT, FIND also has strong programmes in TB, malaria, leishmaniasis and Chagas disease. Launched in 2003, FIND is ISO certified and financed by both the private and public sectors, including the Bill & Melinda Gates Foundation, the Governments of Germany and of the Netherlands, European Union, UNITAID, UK Department for International Development (DFID), National Institutes of Health (USA), UBS Optimus Foundation, among others.

About Standard Diagnostics 
Standard Diagnostics (SD) has developed about 100 different products, including tests for malaria, HIV, dengue fever and syphilis. Since its inception in February 1999, SD has been renowned worldwide for the excellent quality of its rapid point-of-care tests. This quality relies on in-house developed recombinant antigens and monoclonal antibodies that are the key raw materials used in manufacturing the tests. Through international organizations such as WHO, UNICEF, government procurement and overseas distributors, SD products are supplied to more than 120 countries around the world. Rapid tests for malaria and dengue fever account for 60% of worldwide sales. With a turnover of over 100 million US dollars, SD has evolved into a global pharmaceutical manufacturing company specialized in in vitro diagnostics. As a result of the increasing market demand for SD’s new products, additional manufacturing plants are being established in Nigeria and Ethiopia.

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