Cepheid’s BCR-ABL Test Gets FDA Approval


Cepheid announced that it has received clearance from the FDA for its Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia (CML).

An 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.

“Until now, tests for BCR-ABL have not been automated or designed to be run on-demand, which has limited the potential impact of a same-day result in the management of CML patients,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer.  “Because Xpert BCR-ABL Ultra is aligned to the International Scale on a lot-to-lot basis, accuracy and comparability of results is assured no matter which lab or even where in the world the test is performed.  In addition, the added sensitivity provides physicians with the information they need to confidently optimize individual treatment strategies for their patients with CML, including identifying patients who might be considered for a trial of therapy discontinuation.”

Xpert BCR-ABL Ultra is Cepheid’s first FDA-cleared oncology application, though it has a number of other oncology tests in its pipeline. The company said it anticipates launching tests for acute lymphocytic leukemia, acute myeloid leukemia, and solid tumors in the next few years.

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