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Alere Gets CE Mark for Alere q HIV-1/2 Detect Assay

NEW YORK (GenomeWeb) – Alere announced today that it has received CE marking for a rapid molecular diagnostic test for HIV 1/2 on its Alere q platform.

The assay is a point of care test that detects and distinguishes between strains of HIV virus in less than 60 minutes, the Waltham, Mass.-based diagnostics firm said in a statement. It will be applied toward early infant diagnosis.

The Alere q platform is battery powered, fully automated, and cartridge-based, and does not require sample extraction steps. A multiplex reaction runs on-board controls and distinguishes between HIV 1 subgroup M/N, HIV 1 subgroup O, and HIV 2. The test was validated by five clinics in Mozambique and showed high specificity and sensitivity for diagnosing infants, according to a study in the Journal of Acquired Immune Deficiency Syndromes, the firm said.

Alere launched another point of care isothermal nucleic acid amplification platform last year. Called the Alere i, that system has since received FDA clearance and CLIA waiver for an associated influenza test, as well as $12.9 million in federal funding to develop the system for pandemic influenza.

The technology is also being investigated for potential applications for the diagnosis and monitoring of other infectious diseases, such as hepatitis C, tuberculosis, and Ebola, according to today's statement. The firm described its increased focus on the molecular diagnostics market in an earnings call last month.