Cepheid and FIND Announce European Approval of Xpert HIV-1 Viral Load

Cepheid and the Foundation for Innovative New Diagnostics (FIND) today announced that Xpert® HIV-1 Viral Load, a quantitative test for measurement of the HIV-1 viral load in plasma, 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 over 7,500 systems deployed globally in both developed and emerging market countries.

Human Immunodeficiency Virus (HIV) is the microorganism that causes Acquired Immunodeficiency Syndrome (AIDS). HIV viral load refers to the quantitative measurement of the amount of active HIV in the blood of someone who is HIV-positive. This measurement has been established as the standard of care in assessing HIV-positive patient prognosis and response to antiretroviral therapy. The measurement is also commonly used for transmission risk assessment during accidental exposure to blood and at-risk exposure in general.

"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.," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "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 worldwide are currently living with HIV/AIDS¹. People living with HIV are from 26-31 times more likely to develop tuberculosis (TB) than those without HIV. TB is the most common presenting illness among people living with HIV, including those taking antiretroviral treatment, and it is the major cause of HIV-related death².

"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," said Dr. Catharina Boehme, Chief Executive Officer of FIND. "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."

The goal of HIV treatment is to suppress replication of the virus and bring the HIV viral load measurement as low as possible. People with higher viral loads have a greater risk for immune system damage, which increases the risk of opportunistic infections.

"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 (LTR)," said Dr. David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology officer. "By employingCepheid-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."

Xpert HIV-1 Viral Load is expected to begin shipping in February 2015. For more information on the entire CE-IVD menu of Xpert tests, visit www.cepheidinternational.com.


References
1. http://www.who.int/gho/hiv/en/
2. http://www.who.int/tb/challenges/hiv/en/