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Beckman Coulter Gets CE Mark for HCV, HIV-1 MDx Tests

NEW YORK (GenomeWeb) – Beckman Coulter said yesterday that it has garnered CE marking for its DxN Veris HCV and DxN Veris HIV-1 assays, quantitative tests for hepatitis C virus RNA and HIV-1 RNA viral load, respectively, in human plasma.

The DxN Veris HCV assay detects HCV genotypes one to six, and is calibrated to the fourth World Health Organization International Standard for HCV. Beckman Coulter said that the assay run time is around 100 minutes, enabling faster clinical decision making and improved HCV patient management.

Meantime, the DxN Veris HIV-1 test detects HIV-1 Group M, Group N, Group O, CRF AE, and CRF AG subtypes, and is traceable to the WHO International Standard for HIV-1. It is available for 1000-µL and 175-µL sample volumes, and runs in just under 90 minutes.

The assays add to the test menu of Beckman Coulter's DxN Veris molecular diagnostics system, a cartridge-based, fully automated, sample-to-answer instrument for quantitative molecular analysis. The platform integrates sample processing, nucleic acid extraction, reaction setup, real-time TaqMan PCR amplification, and results interpretation.

Beckman Coulter launched the DxN Veris system and first assay, a quantitative viral load test for human cytomegalovirus, in Europe in May. The Danaher-owned company also markets in Europe the DxN Veris HBV assay for quantitative measurement of hepatitis B virus in plasma and serum. The platform is not commercially available in the US.

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