Cepheid, a leading molecular diagnostics company and FIND, an international non-profit organization 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 enables early HIV detection in high-risk and pediatric patients. The test runs on the Cepheid GeneXpert System, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.
Developed in collaboration with FIND, Xpert HIV-1 Qual begins shipping this month as a CE-IVD Mark product.
The World Health Organization estimates that 35 million people worldwide are currently living with HIV. Of those infected, 2.3 million represent new infections and an estimated 260,000 are children.
Without timely HIV testing and therapy initiation, one third of HIV-infected infants will die before their first birthday and more than 50% will die before reaching two years of age.
"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.," said John Bishop, Cepheid's chairman and chief executive officer.
Bishop said "Our GeneXpert System and Xpert tests remain at the forefront of molecular diagnostic innovation, empowering clinicians worldwide with low- or high-volume results that optimize patient outcomes with sample in, answer out simplicity."
"The modular design of the GeneXpert System means that a point-of-care health clinic can run the exact same cartridge-based test as a national reference laboratory," said Dr. Appolinaire Tiam, MBChB, DipHIVMan, MMed. country director for Elizabeth Glaser Pediatric AIDS Foundation/Lesotho.
"This is a unique and powerful tool that will help us provide timely and actionable diagnostics for HIV-infected infants without compromising accuracy of results," Dr Tiam.
"FIND's goal is to make universal access to high-quality diagnostics a reality for people in the developing world," said Dr. Catharina Boehme, chief executive officer of FIND.
"A test that can deliver early diagnosis of HIV infection in high-risk patients and infants, and can also be run on diagnostic systems that are already in use for TB diagnosis has the potential to transform the way the two diseases are managed," Dr Boehme said.
"While early diagnosis of HIV infection in high-risk patients and infants is critical, significant percentages of patients become lost to clinician follow-up," said Dr. David H. Persing, MD, Ph.D., Cepheid's chief medical and technology officer.
"Xpert HIV-1 Qual delivers the highly sensitive, on-demand results needed for same-day diagnosis — the first critical step in saving lives," Dr Persing said.
Based in Sunnyvale, Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.
Founded in 2003, FIND is an international non-profit organization that enables the development and delivery of diagnostic tests for diseases of poverty, including tuberculosis, malaria, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease and Buruli ulcer.