GenoType® MTBDR plus, a new molecular test for multidrug-resistant tuberculosis has recently been approved in Europe. The test, developed by the Foundation for Innovative New Diagnostics (FIND) and Hain Lifescience, offers a fast solution to detect MDR-TB and XDR-TB at a reasonable price, a good condition for the application in poorer countries.
According to the World Health Organization, one third of the world´s total population are infected with the tuberculosis bacillus, an estimated 5,000 people die of the disease every day. As tuberculosis is a main cause of death among persons with HIV-Infections, especially developing countries are affected. Beneath the approval in Europe, FIND and Hain Lifescience have signed an agreement to begin large-scale demonstration projects of the new test in high burden countries like South Africa. “Efficient medical treatment depends on rapid and reliable diagnostics at an affordable price. Together with FIND we are able to roll out the GenoType® MTBDR plus test in high endemic regions of the world. We are confident that we can soon supply local TB laboratories with our new test as well as with the required training and service,” David Hain, General Manager of Hain Lifescience said.
The development of the test addresses the recent outbreaks of MDR-TB, a form of TB in which the TB-bacilli are resistant to rifampicin and isonisazid, and the extensively drug resistant tuberculosis (XDR-TB) with bacilli even resistant to at least three “second-line” drugs used when “first line” treatment has failed. GenoType® MTBDR plus can be used both on culture-based isolates and directly on smear positive sputum samples from patients with pulmonary TB. Preliminary data suggest that the test can detect at least 90% of MDR-TB cases in only a few hours. Conventional methods of detecting drug resistance can take as long as two to three month to produce results.
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