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FIND and Biotec Announce
Development of New Test for Rapid 21 March 2006 – London, UK : The Foundation for Innovative New Diagnostics (FIND) and Biotec Laboratories Ltd. (Biotec) today announce completion of the development of FASTPlaque-Response, a new diagnostic test for multi-drug resistant TB that provides results in just two days, a significant improvement over conventional methods which take weeks to yield results. This new product is a result of public and private collaboration between FIND and Biotec.“We are extremely pleased with the first outcome of our collaboration with FIND,” said Peter Ellis, CEO of Biotec Laboratories Ltd., which has registered the test in Europe. “This new test will give clinicians the opportunity to effectively manage a patient’s treatment at the time of diagnosis, rather than using a standardized treatment in the hope that they got it right.” FASTPlaque-Response is able to detect resistance to the critical TB drug Rifampicin directly from the sputum of patients with advanced tuberculosis, with accuracy comparable to current conventional methods. Rifampicin resistance indicates a high chance of multi-drug resistant (MDR) TB, which is often fatal if incorrectly diagnosed and treated. Some 450,000 people are thought to develop MDR-TB, worldwide, each year. The test works by using mycobacteriophage (virus that infect TB) to reflect the presence of viable TB bacilli within a sample. “It is critical that we are able to identify patients who are infected with TB bacteria that are resistant to current treatment regimens before they transmit the disease or are beyond the ability to respond to available treatments,” said Dr. Giorgio Roscigno, CEO of FIND. “Without effective diagnostics, identifying MDR-TB is largely guess-work, and patients are either treated inappropriately with expensive and toxic therapies they do not need and cannot afford, or fail to get specialized treatment,” he added. The new test will cost less than one tenth of the cost of the more technically demanding molecular tests, the only other rapid test for MDR-TB currently available on the market. The product has received regulatory approval within Europe. Biotec is about to launch the new test globally, with the initial focus in countries with a known high disease burden, such as Eastern Europe, Russian Federation, Central Asia, India, China and South Africa. "Data published to date suggest that the test is both fast and accurate," said Dr Mark Perkins, Chief Scientific Officer of FIND. "With the completion of a current large clinical study in Lima, Peru," he continued, "we expect to have an excellent understanding of test performance in controlled settings. FIND plans to further evaluate this technology through large-scale demonstration projects, which assess the feasibility and impact of using the test in the public sector of low-income countries." Once these projects are completed, the test will be made available for the public sector of developing countries at concessionary prices, as ensured by an agreement signed between FIND and Biotec. - ENDS - For further information please contact: FIND, Dr. Giorgio Roscigno, CEO +41 22 710 0590 (phone) giorgio.roscigno@finddiagnostics.org
Biotec Laboratories
Dr. Richard Mole,
FASTPlaque Product Manager Northbank Communications Gemma Bradley/Katja Stout +44 20 7886 8150 g.bradley@northbankcommunications.com
About FIND (http://www.finddiagnostics.org/) FIND is the only non-profit organisation dedicated solely to the development of diagnostic tests for infectious diseases in developing countries. FIND was established with a five year, $30 million grant from the Bill and Melinda Gates Foundation, supporting a concerted research effort in collaboration with academia and industry with the aim of delivering affordable, simple diagnostics for the priority needs of developing countries. Driven by the huge burden of disease, the existence of global control strategies and the capacity to treat detected cases, FIND has selected tuberculosis as an initial disease focus.
About
Biotec (http://www.biotec.com) Additional Information The new test will determine the susceptibility of a TB strain to Rifampicin, one of the critical drugs used in TB chemotherapy and a marker for multi-drug resistant TB. The test is performed directly on a patient’s sputum and results are available in 2 days. Conventional drug susceptibility testing requires the growth of TB from a sample, a process that may take 3-8 weeks, followed by a second test, which takes an additional three weeks, to determine the drug susceptibility of the isolate. The FASTPlaque-Response test was developed in Biotec’s R&D labs based in Cape Town, South Africa, along with a number of collaborators both within South Africa and also in the UK and India. Manufacturing and distribution takes place at the company's headquarters in Ipswich, U.K. Along with the test, an antimicrobial supplement has been developed, termed NOA (noah). NOA controls contamination, while permitting the TB to be detected effectively. Incorporation of this supplement increases the range of use of the test. Tuberculosis Tuberculosis remains a significant problem as the greatest cause of death globally from a bacterial pathogen. The problem is so severe that the World Health Organization (WHO) has declared TB an emergency, both worldwide and in Africa, more specifically. Tuberculosis is an indiscriminate pathogen. Transmission of the bacterium is by air and can occur from a mere passing contact with an infected individual with active disease. Once infected, the TB bacilli may form a localised infection and remain dormant in the lungs, without causing disease. It is estimated that 1/3 (2 billion) of the world’s population are latently infected with TB. Active infection can occur immediately after infection or after the latent forms have been triggered by a reduction in immune status, such as caused by illness, malnourishment or HIV infection. Lung function is lost and eventually death will occur if untreated. WHO estimates that in 2003, there were 8.8 million cases globally of TB and 1.7 million deaths. Much of the burden of disease is in low resource countries, where the health infrastructure is limited. However, the problem is not confined to these settings. In 2003, 415,786 cases of TB reported in Europe, including an emerging MDR-TB problem. The presence of HIV infection in the population often results in the upsurge of TB, and is a factor driving the TB epidemic in Africa. Until 50 years ago, there were no medicines to cure TB. Now, strains that are resistant to a single drug have been documented in every country surveyed; what is more, strains of TB resistant to all major anti-TB drugs have emerged. Drug-resistant TB is caused by inconsistent or partial treatment, when patients do not take all their medicines regularly for the required period because they start to feel better, because doctors and health workers prescribe the wrong treatment regimens, or because the drug supply is unreliable. A particularly dangerous form of drug-resistant TB is multidrug-resistant TB (MDR-TB), which is defined as the disease caused by TB bacilli resistant to at least isoniazid and rifampicin, the two most powerful anti-TB drugs. Rates of MDR-TB are high in some countries, especially in the former Soviet Union, and threaten TB control efforts.
From a public health perspective, poorly supervised or incomplete treatment of TB is worse than no treatment at all. When people fail to complete standard treatment regimens, or are given the wrong treatment regimen, they may remain infectious. The bacilli in their lungs may develop resistance to anti-TB medicines. People they infect will have the same drug-resistant strain. While drug-resistant TB is generally treatable, it requires extensive chemotherapy (up to two years of treatment) that is often prohibitively expensive (often more than 100 times more expensive than treatment of drug-susceptible TB), and is also more toxic to patients. MDR-TB (Multi-drug resistance) renders standard TB therapy either less or ineffective, and presents a serious public health problem. It is estimated that 450,000 people become infected with MDR-TB per year. MDR-TB can be treated, but treatment is long (2 years or more) and is less effective and much more expensive than standard TB treatment. In addition the drugs used are more toxic, and patients are more likely to have side effects from treatment. |
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