Oct. 7, 2019—Cepheid received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia. It is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under three hours, Cepheid said in a press release.
“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,” David Persing, MD, PhD, Cepheid’s chief medical and technology officer, said in the release. “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 tests for acute lymphocytic leukemia, acute myeloid leukemia, and solid tumors are expected in the next few years.