FDA approves Xpert BCR-ABL Ultra diagnostic assay for chronic myeloid leukemia.- Cepheid
Cepheid announced that it has received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with Chronic Myeloid Leukemia (CML). Xpert BCR-ABL Ultra, an in vitro diagnostic test, is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under 3 hours.
Until now, tests for BCR-ABL have not been automated or designed to be run on-demand. One of the most important aspects of managing CML is regular and frequent monitoring of a patient's response to therapy by measuring BCR-ABL gene transcript levels as an indicator of treatment efficacy and as a predictor of relapse.
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