NEW YORK – Cepheid said today that the US Food and Drug Administration has cleared its Xpert BCR-ABL Ultra test for monitoring disease burden in patients with chronic myeloid leukemia.
The in vitro diagnostic test can deliver accurate molecular results from whole blood samples in less than three hours, the company said in a statement. Measuring BCR-ABL gene transcript levels can indicate how well treatment for CML patients is working and predict relapses.
The test is automated and designed to be run on demand, Cepheid said, and is the company's first FDA-cleared oncology application.
"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," said David Persing, Cepheid's chief medical and technology officer.
The Sunnyvale, California-based firm currently has a broader oncology menu in development, including other Xpert tests for acute lymphocytic leukemia, acute myeloid leukemia, and solid tumors.