NEW YORK (GenomeWeb News) – A study appearing in the Sep. 9 issue of the New England Journal of Medicine has reported unprecedented sensitivity and specificity achieved by Cepheid's new molecular tuberculosis test, driving the company's stock up around 9 percent today.
In mid-afternoon trading, Cepheid shares rose to $17.25, following the publication online yesterday of a study in NEJM in which researchers reported that Cepheid's Xpert MTB/RIF test successfully identified 98.2 percent of all cultured-confirmed TB cases, including more than 90 percent of those with smear-negative disease.
In addition, the PCR-based test had a 97.6 percent success rate in detecting patients with resistance to the anti-TB drug rifampin. Test results were achieved in less than two hours.
The test, designed to be used on Cepheid's GeneXpert system, was co-developed with the Foundation for Innovative New Diagnostics and the University of Medicine and Dentistry of New Jersey. The National Institute of Allergy & Infectious Diseases provided additional funding as did the Bill and Melinda Gates Foundation.
In a statement, NIAID said that in 2008 more than 1.8 million people worldwide died from TB. The number of drug-resistance cases is increasing, as well. "New, less costly tools to rapidly diagnose TB and its drug-resistant forms are urgently needed to help stem the tide of new infections," the institute said.
Separately, Cepheid said the test could have particular implications in developing nations in sub-Saharan Africa and Southeast Asia, where TB and HIV are closely linked.
According to David Persing, chief medical and technology officer for Cepheid, "The Xpert MTB/RIF test is the most technologically advanced test for TB ever developed, yet it is simple enough to perform in all corners of the world, including in resource-limited setting where it is most needed."
The test is CE-IVD marked and is expected to become available in the US within the 2012-2013 timeframe, Cepheid said.
More about the NEJM study can be found in GenomeWeb Daily News' sister publication, PCR Insider.