Cepheid issued the following announcement on Oct. 2.
Cepheid announced that it has received clearance from the U.S. Food and Drug Administration 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.
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.
"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 marks Cepheid's first FDA-cleared oncology application, though a broader oncology menu is currently in development. New Xpert tests for Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, and solid tumors are expected in the next few years.
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, fast, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.
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