Cepheid And FIND Report European Approval Of Xpert HIV-1 Qual

(RTTNews) - Cepheid (CPHD) and FIND announced that Xpert HIV-1 Qual, a qualitative 90-minute molecular HIV test, has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

The test runs on the Cepheid GeneXpert System, the world's leading molecular diagnostic platform with more than 8,000 systems deployed globally in both developed and emerging market countries.

Developed in collaboration with FIND, Xpert HIV-1 Qual will begin shipping this month as a CE-IVD Mark product.

The World Health Organization estimates that 35 million people worldwide are currently living with HIV/AIDS. Of those infected, 2.3 million represent new infections and an estimated 260,000 are children.

John Bishop, Cepheid's Chairman and CEO, said, "Xpert HIV-1 Qual adds to Cepheid's virology test menu, which already includes Xpert HIV-1 Viral Load and Xpert HCV Viral Load, extending our menu of Xpert tests to 22 outside of the U.S. Our GeneXpert System and Xpert tests remain at the forefront of molecular diagnostic innovation..."