Feb. 23, 2006 — Cepheid, a Sunnyvale, Calif., molecular diagnostics company, announced the European launch of its GeneXpert System for in vitro diagnostic use along with the Xpert BCR-ABL Monitor assay, the initial clinical diagnostic test for use on the GeneXpert System.
Both the GeneXpert System and the Xpert BCR-ABL Monitor assay were released as “European Conformity” CE IVD Mark products under the European Directive on In Vitro Diagnostic Medical Devices.
The Xpert BCR-ABL Monitor can be used as an aid in the monitoring of BCR-ABL, an abnormal genetic marker found in patients with chronic myelogenous leukemia.