Cepheid (Nasdaq: CPHD) today announced that its Xpert® MTB/RIF test was the subject of a study published in the latest edition of the New England Journal of Medicine (NEJM), "Rapid Molecular Detection of Tuberculosis and Rifampin Resistance." The complete study is now available online (http://www.nejm.org) and will appear in the September 9 print edition.
Funded and led by the Foundation for Innovative New Diagnostics (FIND), the study compared the sensitivity and specificity of Xpert MTB/RIF to the best available reference standards in the diagnosis of 1,730 patients with suspected drug-sensitive or multi drug-resistant pulmonary tuberculosis (TB) at five centers in Peru, Azerbaijan, South Africa, and India. The study concluded that Cepheid's Xpert MTB/RIF - an easy-to-use molecular test developed in partnership with FIND and the University of Medicine and Dentistry of New Jersey (UMDNJ), with additional funding from the National Institute of Allergy & Infectious Diseases (NIAID) - provided sensitive and specific detection of tuberculosis and rifampin resistance (a critical marker of multidrug resistance) directly from untreated sputum specimens in less than two hours.
"One of FIND's primary goals is to help save the millions of lives needlessly lost to TB every year," said Giorgio Roscigno, chief executive officer of FIND. "Early, rapid and accurate detection of TB, including identification of drug-resistant strains, is critical to effectively treating the disease, reducing secondary resistance, stopping further transmission and saving lives. Cepheid's commitment to researching and bringing this test to market has been outstanding. This study demonstrates that Xpert MTB/RIF delivers a quantum leap in patient management to the developing world, where it is most needed. We are proud to be a part of this landmark project."
Designed for use on Cepheid's GeneXpert® Systems, Xpert MTB/RIF not only detects the presence of TB, but also identifies whether it is resistant to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant (MDR-TB). The CE-IVD test is enabling physicians outside of the U.S. to dramatically improve patient outcomes through rapid, actionable results that guide therapy decisions within the timeframe of an initial patient visit.
"The need for accurate and rapid detection of tuberculosis for the growing at-risk populations in the developing world has been well documented," said John Bishop, Cepheid's chief executive officer. "The GeneXpert System has a unique level of technical capability - no other molecular system could have enabled a TB test as accurate, fast, and easy-to-use as Xpert MTB/RIF. Clinicians are now able to obtain dependable test results for not only detection of TB, but also simultaneous determination of whether or not it is a drug resistant strain in virtually any clinical setting."