Cepheid and FIND (Foundation for Innovative New Diagnostics) today announced a new collaboration to accelerate the development of a rapid molecular test for the measurement of human immunodeficiency virus (HIV) viral load.
The Xpert HIV viral load test, which will run on Cepheid's GeneXpert(R) platform, is expected to complement the ground-breaking Xpert MTB/RIF test for tuberculosis (TB) and drug-resistance, the result of a collaboration between Cepheid, FIND and other partners which was profiled in an article in the New England Journal of Medicine and endorsed by the World Health Organization in late 2010.
Under the agreement, FIND will also obtain concessionary pricing in developing countries for Cepheid's sexually transmitted diseases (STD) test for Chlamydia and Gonorrhea, currently under development. The resulting program is expected to deliver the benefits of rapid and accurate molecular testing for TB, HIV and STDs using a single instrument in some of the most challenging geographies across the globe.
"Given the particular challenges presented by HIV and TB co-infection, we believe that the Xpert HIV viral load test will be an excellent complement to Xpert MTB/RIF, dramatically improving endemic countries' capacity to diagnose and manage these infections," said Dr Giorgio Roscigno, Chief Executive Officer of FIND. "This new collaboration confirms the possibility of creating diagnostic platforms for several diseases, thus extending the reach of scarce resources intended to combat them."
"The GeneXpert System is unique in its ability to deliver the clinical benefits of molecular testing for virtually any infectious disease in almost any setting, and Cepheid is proud to continue its contribution to the global effort against TB and extend that contribution into HIV," said John Bishop, Cepheid's Chief Executive Officer. "As a result of the broad applicability of the GeneXpert System, investments being made available today in the fight against TB can be leveraged to the maximum benefit of high burden developing countries, since they will be able to use the same system for the detection and management of many different types of disease."
Worldwide, TB is the leading cause of death among people living with HIV which is the most potent risk factor for the development of tuberculosis. HIV prevalence among TB patients has been estimated to be as high as 80%-90% in some areas of sub-Saharan Africa [1 <http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5711a3.htm> ]. In 2004, the WHO recommended increasing collaboration between HIV and TB programs [2]. However, the WHO estimated in 2010 that only about 5% of people living with HIV were screened for TB [3]. One of the big hurdles to the effective co-management of HIV and TB is the lack of combined services, and patients are often sent back and forth between TB and HIV centers. An HIV viral load test which can be used on the same machine as the WHO-recommended Xpert MTB/RIF test would have the potential to revolutionize 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.
Under the terms of the collaboration, FIND will fund $5 million in development costs for the Xpert HIV test. The investment is spread across the life of the project, with the first payment in the first quarter of 2011, and the last payment expected in the first quarter of 2013. When commercially available, FIND will gain rights allowing Cepheid's Xpert HIV viral load test and the Xpert Chlamydia and Gonorrhea test to be sold at reduced prices to the public and not-for-profit sector in many countries, delivering the benefits of rapid and accurate molecular testing to high burden developing countries around the world.
References:
1. CDC. Provider-initiated HIV testing and counseling of TB patients---Livingstone District, Zambia, September 2004--December 2006. MMWR 2008;57:285-9. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5711a3.htm
2. World Health Organization. Interim policy on collaborative TB/HIV activities. Geneva, Switzerland: World Health Organization; 2004. Available at http://whqlibdoc.who.int/hq/2004/who_htm_tb_2004.330_eng.pdf.
3. World Health Organization. TB/HIV Facts 2010. Geneva, Switzerland: World Health Organization; 2010. Available at www.who.int/tb/challenges/hiv/factsheet_hivtb_2010.pdf.
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