Media statement

FIND, the SAMRC and NHLS seal MOU to begin trial of two new tests for MDR-TB in South Africa

Pretoria, South Africa and Geneva, Switzerland, 12 March 2007 - A Memorandum of Understanding (MOU) was established on 12 March 2007 between the Foundation for Innovative New Diagnostics (FIND), the South African Medical Research Council (SAMRC) and the National Health Laboratory Service (NHLS) to undertake large scale demonstration studies in anticipation of the roll-out of two new tests for the rapid diagnosis of multidrug-resistant tuberculosis (MDR-TB).  
 
The MOU was signed jointly by Dr Giorgio Roscigno, FIND Chief Executive Officer (CEO), Prof Anthony Mbewu, SAMRC President, and John Robertson, CEO of the NHLS during a special ceremony held at the SAMRC in Pretoria, South Africa.
 
For the three parties, these projects represent a concrete and rapid response to the recently highlighted outbreaks of extensively drug-resistant TB (XDR-TB) in the country.  Experts consider this form of TB to be rapidly fatal, especially if associated with HIV/AIDS.
 
“This is a great step forward in accelerating access to new tools for better diagnosis of TB to prevent the spread of MDR-TB and XDR-TB in South Africa and also in other countries affected by this disease,” said Dr Giorgio Roscigno, FIND CEO.
 
The two new technologies are the FASTPlaque-Response® test from Biotec, Ltd., and the MTBDRplus® assay from Hain Lifescience, Gmbh.  FIND has partnered with both of these companies on the development of the assays, which enable the presumptive diagnosis of MDR TB in just one to two days, compared with two or more months when using conventional culture and drug susceptibility tests.

Rapid diagnosis of MDR-TB will have several benefits.  These include earlier treatment of patients which will undoubtedly save more lives, reducing the time spent on inappropriate and ineffective patient treatment (thereby promoting the development of further drug resistance), and reducing the spread of MDR-TB in congregate settings.  Most importantly, early identification of MDR-TB will allow much faster investigation into the possibility that patients may have XDR-TB, speeding up the time to diagnose MDR-TB patients who should then be fast-tracked for XDR-TB laboratory tests.
 
As the largest provider of TB diagnostic services in South Africa, the NHLS is excited about this ambitious initiative and the possibility of bringing modern TB diagnostics to better serve TB patients throughout South Africa, said John Robertson, CEO of the NHLS.
 
The project’s protocol, which will evaluate the tests in 40,000 TB patients who are at increased risk of MDR-TB during the next 12 months, was approved by the SAMRC Ethics Committee last week. Project preparation is underway in five South African provinces most affected by the disease namely Gauteng, KwaZulu-Natal, the Northern Cape, North-West Province and Western Cape.  Testing is scheduled to begin on 1 April 2007and expected to last for 12 months.  Scale-up to the other four provinces is also envisaged.
 
”These demonstration projects are the beginning of what we hope will be a long and fruitful collaboration between the Medical Research Council of South Africa and FIND Diagnostics in bringing new, validated, affordable and highly effective diagnostics to South Africa and other African countries” said Prof Anthony Mbewu, President of the SAMRC.
 
Based on the results of the demonstration studies, the SAMRC and NHLS will issue policy recommendations on the routine use and roll-out of the two tests in the National TB Control Programme of the Department of Health.  The data will also be presented to the World Health Organization for formulation of guidelines on the use of these rapid diagnostics for global MDR-TB control.
 
Dr Mario Raviglione, Director of WHO's Stop TB Department said, "We are very pleased that, following our global call for action to address XDR- TB, our partners, FIND, the SAMRC, and the NHLS, have embarked on this remarkable and laudable initiative.  We eagerly look forward to the results as a prelude to the rapidly expanded use of these technologies to address the MDR-TB and XDR-TB emergency."

For more information, please contact:

• FIND
  Dr Rick O’Brien
  Tel:  +41 22 710-0590
• SAMRC
  Dr Karin Weyer
  Tel:  +27 12 339-8550
• NHLS
  Dr John Robertson
  Tel:  +27 11 386-6070
• WHO
  Dr Mario Raviglione
  Tel:  +41 22 791-2663

About FIND (www.finddiagnostics.org)
The Foundation for Innovative New Diagnostics (FIND) is a non-profit Swiss foundation based in Geneva. Its purpose is to support and promote the health of people in developing countries by sponsoring the development and introduction of new but affordable diagnostic tools for poverty related diseases. FIND’s current donors include the Bill & Melinda Gates Foundation, USAID, the European Union and the Dutch Government.

About the National Health Laboratory Service (NHLS)
The NHLS mission is to provide cost-effective and professional laboratory medicine through state-of-the art technology to all South Africans.  Its research focuses on major South African health problems, including HIV/AIDS, tuberculosis, cancer and malaria.

About the South African Medical Research Council (www.mrc.ac.za)
The Medical Research Council is the Statutory Council for Health Research in South Africa, with a vision of building a healthy nation through research. It is an independent parastatal institution, reporting to the National Department of Health, and receiving half its budget of R420 million from the South African Government. The SAMRC carries out research across the whole spectrum of health and disease, using the methodologies of modern health research from the laboratory, to the clinic and to the community. The SAMRC funds over 600 scientists, and produce 40% of South Africa’s health research output with more than 600 peer reviewed publications per annum, as well as numerous technical reports and patents.