Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to ...( Unique GeneXpert(R) System Capabiliti...),Health

Unique GeneXpert(R) System Capabilities Enable Powerful New TB Diagnostic Tool

SUNNYVALE, Calif., April 27 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the release of Xpert(R) MTB/RIF as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. For the first time, European clinicians will have access to a rapid test that can simultaneously identify Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF), a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB).

Xpert MTB/RIF is expected to enable clinicians to dramatically improve patient outcomes -- a situation possible only through on-demand, actionable test results that can help guide therapy decisions during an initial patient visit. The new test, developed in partnership with the Foundation for Innovative New Diagnostics (FIND), the University of Medicine and Dentistry of New Jersey (UMDNJ), and funded by the National Institute of Allergy & Infectious Diseases (NIAID), will leverage the power of Cepheid's GeneXpert(R) System to deliver a highly accurate diagnosis of the disease in less than two hours.

According to the World Health Organization (WHO), approximately two billion people are currently infected with MTB. An estimated nine million people develop active TB each year, and two million people lose their lives to the illness. This equates to one life every 20 seconds.

"With the documented re-emergence of TB and the development of drug-resistant strains, the need for accurate and rapid detection of tuberculosis is becoming increasingly acute," said John Bishop, Cepheid's Chief Executive Officer. "The GeneXpert System has a unique level of technical capability never be
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