Cepheid, a leading molecular diagnostics company, has received market authorisation from the US Food & Drug Administration (FDA) for its Xpert MTB/RIF test. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market. Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.
"With results available to clinicians in approximately two hours instead of weeks, the dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the US," said John Bishop, Cepheid's chairman and chief executive officer. "Now, US clinicians can leverage those same transformative results not only for the detection of TB (tuberculosis), but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."
Designed for use on Cepheid's GeneXpert Systems, Xpert MTB/RIF not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant (MDR-TB). Patients with multidrug-resistant TB need more intensive and prolonged therapy. Xpert MTB/RIF will enable US clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not six weeks later as is the case with standard laboratory methods.
"Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country," said David H Persing, MD, Ph.D., Cepheid's chief medical and technology officer. "About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the US, as already demonstrated abroad."
Tuberculosis remains a major global health concern, with an estimated 8.7 million new cases reported worldwide in 2011 according to the WHO. Continuing the decline in TB cases in the United States will require sustained focus on domestic TB control activities and further support of global TB control initiatives.
Xpert MTB/RIF is now available for immediate shipment in the US.
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.