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Cepheid Launches TB Test under CE IVD Directive

NEW YORK (GenomeWeb News) – Cepheid today said that it has launched its Xpert MTB/RIF test as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.

The test, which runs on the firm's GeneXpert System, simultaneously identifies Mycobacterium tuberculosis and resistance to first-line drug therapy rifampicin.

According to Cepheid, around 90,000 new TB cases and 10,000 TB-related deaths occur each year in Europe. It said that the World Health Organization estimates that around 2 billion people currently are infected with MTB, with 9 million people developing active TB each year.

"With the documented re-emergence of TB and the development of drug-resistant strains, the need for accurate and rapid detection of tuberculosis is becoming increasingly acute," said Cepheid CEO John Bishop in a statement.

The test was developed in collaboration with the Foundation for Innovative New Diagnostics and the University of Medicine and Dentistry of New Jersey, and was funded by the National Institute of Allergy & Infectious Diseases. According to the firm, it can provide results in around two hours.

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