US-based molecular diagnostics firm Cepheid and FIND, a non-profit organisation, have secured CE-IVD status for Xpert HIV-1 Qual, a qualitative 90-minute molecular HIV test.
Xpert HIV-1 Qual test, which runs on the Cepheid GeneXpert System, achieved CE-IVD status under the European Directive on In-Vitro Diagnostic Medical Devices.
More than 8,000 Cepheid GeneXpert Systems were deployed globally in developed and emerging market countries.
Cepheid chairman John Bishop 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 US.
"Our GeneXpert System and Xpert tests remain at the forefront of molecular diagnostic innovation, empowering clinicians worldwide with low or high-volume results that optimise patient outcomes with sample in, answer out simplicity."
More than 35 million people worldwide are currently living with HIV/AIDS, out of which 2.3 million represent new infections and an estimated 260,000 are children, according to the World Health Organisation (WHO).
FIND CEO Dr Catharina Boehme said: "FIND's goal is to make universal access to high-quality diagnostics a reality for people in the developing world.
"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."
Xpert HIV-1 Qual was developed in collaboration with FIND and it begins shipping this month as a CE-IVD Mark product.
Cepheid chief medical and technology officer Dr David Persing 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.
"Xpert HIV-1 Qual delivers the highly sensitive, on-demand results needed for same-day diagnosis, the first critical step in saving lives."
Image: Xpert HIV-1 Qual, a qualitative 90-minute molecular HIV test. Photo: courtesy of PRNewswire/Cepheid.