Cepheid Announces ‘Ride Against TB’ Campaign with Custom Chopper Unveiling

Cepheid has announced today a ‘Ride Against TB’ campaign with the live unveiling of a custom chopper by Paul Teutul, Jr. of the Discovery Channel show, American Chopper. The announcement has been made at the AACC Clinical Lab Expo being held in Houston this week — one of the top 5 cities in the U.S. with the highest prevalence rates of TB.

The goal of the campaign, which runs now through a planned World TB Day event in March 2014, is to heighten U.S. awareness of the need for improved diagnostic solutions for the rapid detection of TB and to raise funds to benefit the American Lung Association.

In the early 1900s, TB was the leading cause of death in the United States. The disease is still a global problem -- the World Health Organization has declared tuberculosis a global emergency. Current estimates are that one-third of the world's population has latent TB. The previous lack of an accurate and rapid diagnostic test for TB had been the greatest roadblock to begin controlling the disease.

Last week, Cepheid announced it had received market authorization from the U.S. 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 2 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 U.S.1," said John Bishop, Cepheid's Chairman and Chief Executive Officer.

"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."

Xpert MTB/RIF is now available for immediate shipment in the U.S.