Cepheid Announces European Release of Test for Simultaneous Detection of MTB and Resistance to Rifampicin
News May 04, 2009
Cepheid has announced the release of Xpert® 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 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 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® 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 before seen in molecular diagnostics - and this capability is on full display with this test. Clinicians will now be able to obtain dependable test results in virtually any clinical setting not only for detection of TB, but simultaneous determination of whether or not it is a drug resistant strain. Xpert MTB/RIF should be a breakthrough technological leap forward in helping to ensure appropriate therapeutic management and in helping to halt transmission of this disease,” he continued.
“I would also like to note that the Xpert MTB/RIF is Cepheid’s first test released in the new Reagents on Board configuration. This new test configuration includes the packaging of liquid reagents along with the previously included dry reagents in the test cartridge. This added feature makes the test procedure even easier to perform and further reduces hands-on time to about one minute. This new test configuration is also expected to form the foundation for Cepheid’s projected future line of CLIA waived products”.
Appropriate therapeutic management has been a significant factor in the development of drug resistant TB strains. Optimal management of the disease requires access to detection, prevention, and treatment.
“Rapid diagnosis of rifampicin-resistant TB will have will have three main benefits, including earlier proper treatment, earlier interruption of the transmission chain-of resistant strains, and promote appropriate accommodation of patients infected with a resistant strain,” said Dr. Sabine Rusch-Gerdes, Head of the National Reference Center for Mycobacteria, Borstel, Germany. “This will undoubtedly save more lives by reducing the time spent on inappropriate and ineffective patient treatment which ultimately promotes the development of further drug resistance.”
According to data published by WHO, only 2 percent of multidrug-resistant (MDR) TB cases worldwide are being diagnosed and treated appropriately. This may leave 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.”