New Diagnostics Help Fight Tuberculosis - FIND And Hain Lifescience Plan Worldwide Demonstration Projects

Main Category: Tuberculosis
Article Date: 14 Jan 2007 - 2:00 PDT


The Foundation for Innovative New Diagnostics (FIND) and Hain Lifescience (Hain) announced today that the Hain "GenoType® MTBDR plus" test, a new improved molecular test for multidrug-resistant tuberculosis (MDR-TB), has been approved in Europe and that they have signed an agreement to begin large-scale demonstration projects of the test in high burden countries.

The announcement came just two months after an initial agreement between FIND and Hain Lifescience to fast-track the development of a new tool to address the recent outbreaks of MDR-TB and extensively drug resistant tuberculosis (XDR-TB). In the case of MDR-TB, the TB-bacilli are resistant to rifampicin and isoniazid, two of the most important drugs used to treat TB. XDR-TB organisms are also resistant to at least three "second-line" TB drugs used when "first-line" treatment has failed.

The new Hain "GenoType® MTBDR plus" test, which is CE marked, 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 months to produce results. Consequently, this new test may revolutionize TB diagnostics.

According to the World Health Organization, two billion people or one-third of the world's total population are infected with the TB bacillus. Nearly nine million people develop TB disease each year, and an estimated 5,000 people die of the disease every day. TB is also the main cause of death among persons with HIV-infection. In Africa, Asia and Eastern Europe tuberculosis is becoming a major threat to public health and economy as it affects mostly young adults in their productive years.

"Efficient medical treatment depends on rapid and reliable diagnostics at an affordable price", says David Hain, General Manager of Hain Lifescience. "With FIND we are happy to have a partner who will help us to successfully roll out our "GenoType® MTBDR plus" test in high endemic regions of the world. We are very confident that we can soon supply local TB laboratories with our new test as well as with the required training and service. It is needed."

FIND will now organize and manage the new demonstration trials planned to be implemented in South Africa, Russia, Uzbekistan and Nepal, exemplifying its role as bridge between industry and the health system of developing countries. As part of the agreement, both Hain Lifescience and FIND have worked to make this test affordable for countries who are most affected by the disease.

"It is imperative to introduce effective and inexpensive tools as soon as possible for diagnosing MDR-TB, and by extension, XDR-TB, before this epidemic reaches unfathomable proportions," said Dr Giorgio Roscigno, FIND CEO. "We look forward to collaborating with Hain Lifescience on these demonstration trials."

These projects are expected to begin in the first quarter of 2007.

About FIND

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.
For more information: http://www.finddiagnostics.org

About Hain Lifescience

Hain Lifescience GmbH is an innovative manufacturer and supplier of modern diagnostic systems. The Hain assays are based on the DNA•Strip® technology, a robust and reliable method for routine diagnostics of disease-associated polymorphisms, microbiological species differentiation and resistance determination. Founded and managed by the brothers David and Tobias Hain in 1986, Hain Lifescience has grown to 60 specialized employees in Nehren, Germany.
For more information: http://www.hain-lifescience.de

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