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RT-PCR HIV-1 Diagnostic by Abbott and Celera Gets CE Mark

NEW YORK, June 16 (GenomeWeb News) - An Abbott and Celera Diagnostics HIV-1 viral-load test has been awarded the European Union's CE Mark certification, the companies said today in a statement.

 

The CE Mark allows the companies to sell the PCR-based RealTime HIV-1 assay in the 25 member states of the European Union under the In Vitro Diagnostics Directive, the companies said.

 

The HIV-1 assay runs on Abbott's m2000 real-time PCR system. Abbot said it is also developing methods for detecting hepatitis C, hepatitis B, chlamydia, and gonorrhea that will run on the m2000 system.

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