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Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin
Date:4/27/2009

ve MDR-TB patients untreated for weeks or months, leading to an increased likelihood of community transmission and eventual death of the patient.

"Multidrug-resistant TB is becoming increasingly prevalent throughout the world, making TB harder to treat with the usual regimen that includes rifampicin," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "In my opinion, this new test is one of the most important diagnostic developments to have occurred in many years. It is the most technologically advanced test for TB ever developed, yet it is simple enough to perform anywhere testing is needed."

Currently, the most common testing method for TB is sputum microscopy, or the smear test, that has remained largely unchanged in its sophistication and sensitivity for over 100 years. The smear test has been proven to only detect around half of all active TB cases and is not capable of identifying drug resistance. As a result, TB is under-diagnosed today -- a major contributor to the 90,000 new TB cases and 10,000 deaths that occur annually in Europe alone. The Health Protection Agency recently announced that the number of TB cases reported in the United Kingdom is actually increasing, with a 2 percent rise in reported cases in 2008 when compared to 2007.

Patients who remain undetected are often co-mingled within general hospital populations, placing others at risk of infection. Due to their low accuracy, smear tests are followed up with culture tests, which offer more accurate results but take several weeks. To determine drug resistance, culture testing can take months to return a result.

"We designed this test so that it could be used by someone with minimal training," said UMDNJ's David Alland, M.D. who collaborated closely with Cepheid and FIND with support from the NIAID. "We're gratified to find that it requires less hands-on work than the acid fast smear,
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