FDA categorizes Cepheid's Xpert MTB/RIF test as 'Moderate Complexity' under CLIA

CepheidAug 28 2013

Cepheid (NASDAQ: CPHD) today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert^® MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). 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. The test runs on Cepheid's GeneXpert^® Systems and is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.

"The 'Moderate Complexity' categorization of Xpert MTB/RIF will allow a broad range of healthcare facilities access to actionable results in approximately 2 hours instead of weeks," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "The dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the U.S.¹ Now, U.S. 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 U.S. clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not 6 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, M.D., 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 U.S., as already demonstrated abroad."

In the early 1900s TB was the leading cause of death in the United States. Tuberculosis disease and deaths have declined steadily from the early 1900s due largely to the introduction of effective antibiotics and improvements in living conditions. While some improvements in global control of TB have been achieved over the last decade, TB continues to be a leading cause of death from an infectious disease in many countries. In 1993, the World Health Organization (WHO) declared TB a "global health emergency." ²