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Cepheid's HIV MDx Assay Gains CE-IVD Mark

NEW YORK (GenomeWeb) – Cepheid and the Foundation for Innovative New Diagnostics today announced that the Xpert HIV-1 Viral Load has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

The test runs on Cepheid's GeneXpert System and is the eighth product release from the company this year, marking Cepheid's "entry into the foundational elements of the virology market and [extending] our menu of Xpert tests to 20 outside of the US," Cepheid Chairman and CEO John Bishop said in a statement. The assay is expected to start shipping in February 2015.

Citing statistics from the World Health Organization, Cepheid and FIND said that more than 35 million people globally have HIV/AIDS and added that people with HIV are 26 to 31 times more likely to develop tuberculosis compared to those without HIV. TB is the most common presenting illness among HIV patients and is a major cause of HIV-related death.

"Given the challenges presented by HIV and TB co-infection, we believe that Xpert HIV-1 Viral Load will be an excellent addition to Xpert MTB/RIF, dramatically improving endemic countries' capacity to diagnose and manage these infections," FIND CEO Catharina Boehme said.

In October, FIND, Cepheid, and Rutgers New Jersey Medical Schoolsaid they would develop a next-generation test for Mycobacterium tuberculosis called Xpert MTB/RIF Ultra for detecting patients with smear-negative TB, which is often associated with HIV co-infection.