Xpert HIV-1 Viral Load test nets European approval

Cepheid and the Foundation for Innovative New Diagnostics (FIND) said recently that their Xpert HIV-1 Viral Load has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices.

The Xpert HIV-1 Viral Load is a test used to measure the extent of the HIV-1 virus in plasma. The test runs on the Cepheid GeneXpert System, a molecular diagnostic platform that has more than 7,500 systems worldwide.

"Xpert HIV-1 Viral Load, our eighth product release in 2014, marks Cepheid's entry into the foundational elements of the virology market and extends our menu of Xpert tests to 20 outside of the U.S.," Cepheid Chairman and CEO John Bishop said. "Cepheid's GeneXpert System and Xpert tests remain at the forefront of innovation in the field of molecular diagnostics — delivering the power of on-demand molecular testing to virtually any location worldwide."

The World Health Organization estimates that 35 million people globally are living with HIV/AIDS. The goal of HIV treatment is to stop replication of the virus and bring the viral load measurement as low as possible.

"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 Dr. Catharina Boehme said. "Our goal is to make quality diagnostics a reality for people in the developing world. An HIV viral load test which can be run on the same system as the WHO-recommended Xpert MTB/RIF has the potential to transform the way the two diseases are managed, and perhaps act as a catalyst to ensure a much more holistic approach to TB/HIV co-infections."

Xpert HIV-1 Viral Load is expected to begin shipping this February.

"Xpert HIV-1 Viral Load is the first commercially available test designed around exclusive targeting of the most conserved element of the HIV viral genome, the Long Terminal Repeat," Cepheid Chief Medical and Technology Officer Dr. David Persing said. "By employing Cepheid-proprietary special chemistries, LTR-specific reagents and novel control strategies, we were able to develop a next-generation HIV test that is arguably best-in-class with respect to analytical sensitivity and HIV strain coverage."