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Rapid economical TB tests with Biotec Laboratories
Press releaseMay 2004 FIND speeds development of rapid economical TB tests with Biotec LaboratoriesAim to provide Tuberculosis tests yielding results within 48 hours, rather than weeks First new TB test to be available in 2005The Foundation for Innovative New Diagnostics (FIND) and Biotec Laboratories Ltd. this week announce a milestone that will speed the process of delivering simple, rapid diagnostic tests for tuberculosis to developing countries. Following the launch of FIND in May 2003 at the World Health Assembly, its first development agreement has been signed with Biotec Laboratories Ltd, an established independent UK company with expertise in the development of a number of diagnostic products. FIND’s involvement will accelerate the development, evaluation and demonstration of two improved diagnostic tests that use Biotec’s FASTPlaque technology. One of these tests will enable rapid and sensitive detection of tuberculosis (TB) in patients seeking a diagnosis, while the other will be used in TB cases to detect multi-drug resistance directly from sputum. The development target is a test that is as accurate as culture, the current internationally recognised standard, but that gives results in 48 hours rather than several weeks, and that uses a simple manual procedure that is easy to perform in routine laboratories. The FIND investment will be used primarily to enhance the capacity of Biotec’s R&D facilities in Cape Town, South Africa, which will accelerate the development of these tests. “Improved case detection is the highest priority for TB Control. This technology has the potential to replace existing slow culture methods, boosting TB case detection far above that achieved with microscopy alone by bringing a rapid and sensitive test to developing country laboratories”, said Dr. Mark Perkins, Chief Scientific Officer of FIND. FIND, a non-profit organisation, will leverage its development investment with Biotec to ensure affordability of the tests for low-income countries where they are most urgently needed. Under the terms of this agreement, FIND has obtained a royalty-free license for the use of this technology in the public health sector of low-income countries, with Biotec retaining exclusive rights for the private health sector in low-income countries and all markets in high income countries. “Through this unique partnership, we are addressing the critical need for improved diagnostic tests for tuberculosis. Our investment in Biotec’s FASTPlaque technology signifies real progress - we are aiming for availability of these tests as early as 2005” said Dr. Giorgio Roscigno, Chief Executive Officer for FIND. Ian Dalgleish, Chairman of Biotec said, “This is an exciting new partnership. FIND is changing the way that TB diagnostics are developed. By applying their considerable expertise and financial resources in such a focused way, FIND will dramatically accelerate our new product development programme, and help to open up those markets where the need for new, simple, rapid TB diagnostics is most acute. We are very encouraged by this endorsement of the considerable effort and investment Biotec has already made in developing this technology into a valuable product.” One use of these new FASTPlaque tests is to screen for rifampicin resistant strains directly from sputum. FIND is collaborating with the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) to evaluate the accuracy and effectiveness of this newly developed test for drug resistance that gives a result in 2 days. Existing indirect methods to detect drug resistance in TB give results only after weeks to months of delay, which markedly decreases their utility for patient care. “We are very happy to hear about this progress from FIND, the lead Agency for Diagnostics of the STOP TB Partnership” said Dr. Marcos Espinal, the Partnership’s Executive Secretary. “Moreover, this announcement coincides with the release of the World Health Organisation third global report on ’Anti-TB Drug Resistance in the Developing World’ This report highlights the utility of rapid rifampicin resistance tests in TB to predict multi-drug resistance in areas where it is prevalent”. See also news article from Clinica 1107 - May 14, 2004 (pdf, 18Kb) Biotec
Laboratories Ltd. FastPlaque tests website:
www.biotec.com/fptb Media inquiries: Foundation for Innovative New Diagnostics (FIND)
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