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FDA Clears Cepheid's TB Test

NEW YORK (GenomeWeb News) – Cepheid said after the close of the market on Thursday that its Xpert MTB/RIF test has received de novo 510(k) clearance from the US Food and Drug Administration for marketing in the US.

The test is available for immediate shipment in the US.

The test, which runs on Cepheid's GeneXpert Systems detects Mycobacetrium tuberculosis complex (MTB-complex) DNA. Additionally, it also detects rifampin-resistant associated mutations of the rpoB gene. Rifampin is a first-line drug for treating TB and a reliable marker of strains that may be multidrug-resistant, the Sunnyvale, Calif.-based company said.

With the test, results can be achieved in two hours, compared to up to three months with traditional methods of detecting drug-resistant TB, FDA said. Cepheid developed Xpert MTB/RIF in collaboration with the Foundation for Innovative New Diagnostics (FIND) and the University of Medicine and Dentistry of New Jersey, and with funding from FIND, the National Institutes of Health, and the Gates Foundation.

"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 the US," Cepheid Chairman and CEO John Bishop, said in a statement. "Now, US clinicians can leverage those same transformative results not only for the detection of TB, but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."

According to FDA, Xpert MTB/RIF is the first test reviewed by the agency that can simultaneously detect TB-causing bacteria and determine if the bacteria has genetic markers that make them resistant to rifampin.

"Less complex tests such as the Xpert MTB/RIF Assay can be used in more diverse settings," said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological. "The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat."

Citing statistics from the World Health Organization, Cepheid said that an estimated 8.7 million new cases of TB were reported in 2011 across the globe.