NEW YORK (GenomeWeb News) — European Union regulators have cleared an Abbott assay that uses real-time PCR to monitor hepatitis B viral loads, Abbott and partner Celera Diagnostics said yesterday.
The certification allows the companies to market the test in the EU. The test runs on Abbott’s m2000 instrument, which uses PCR technology made by Applied Biosystems.
The m2000 also runs PCR tests for HIV-1, hepatitis C, chlamydia, and a combination test for chlamydia or gonorrhea.
Abbott and Celera Diagnostics received a CE Mark in 2005 for tests that monitor hepatitis C and HIV-1. The HIV-1 assay was also cleared by the US Food and Drug Administration in May.