Cepheid Receives FDA Clearance for Expanded Claims on Tuberculosis Test

Cepheid has announced it has received clearance from the U.S. Food & Drug Administration (FDA) for expanded claims on its Xpert® MTB/RIF test. Xpert MTB/RIF detects Mycobacterium tuberculosis complex (MTB-complex) DNA and in positive specimens, provides simultaneous identification of rifampin-resistance associated mutations of the rpoB gene.

The expanded product claim enables clinicians to use either one or two negative Xpert MTB/RIF test results, in conjunction with other clinical and laboratory data, to remove patients from airborne infection isolation (AII), commonly referred to as respiratory isolation. The test runs on the Cepheid GeneXpert ® System, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.

"Xpert MTB/RIF has been heralded as a game-changer with its ability to deliver actionable results in under two hours. This claim expansion significantly extends the diagnostic utility of Xpert MTB/RIF for U.S. hospitals," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Placing patients in respiratory isolation is expensive for healthcare facilities and can impede patient care."

Despite the continued decline in U.S. TB cases and rates since 1993, the goal of TB elimination in the United States remains unmet. Most states reported fewer cases of TB in 2013. However, elevated rates of TB in specific populations remain a major challenge that impedes progress toward TB elimination. The TB incidence rate among foreign-born persons in 2013 was approximately 13 times greater than the incidence rate among U.S.-born persons, and the proportion of TB cases occurring in foreign-born persons continues to increase, reaching 64.6% in 2013.1

"Although the incidence of tuberculosis in the U.S. is low, due in large part to successful public health strategies, the number of patients being evaluated for possible tuberculosis is still significant," said Dr. David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert MTB/RIF returns test results in two hours, allowing clinicians to discontinue airborne infection isolation precautions quickly rather than waiting days or weeks for the return of three negative smear tests. The ability to quickly differentiate patients that require TB respiratory isolation from those that do not pose a risk of transmitting TB will allow hospitals to focus their infection control efforts where they can have the greatest impact."

The Xpert MTB/RIF package instruction sheet with the new expanded claims is available on Cepheid's website at the following URL: www.cepheid.com/us/mtbrif-pi.

References:
1. Alami NN, et al. Trends in Tuberculosis — United States, 2013, MMWR Volume 63 / No. 11 March 21, 2014