The test, which runs on Cepheid’s GeneXpert system, aids in detecting the BCR-ABL fusion gene in the peripheral blood of patients with chronic myelogenous leukemia (CML) in about two hours.
Monitoring the levels of BCR-ABL mRNA transcript in the blood of CML patients on tyrosine kinase inhibitors (TKIs) using real-time quantitative PCR is the standard of care in the management of CML.
Cepheid CEO John Bishop said the updated Xpert BCR-ABL Monitor test incorporates a validated test-specific conversion factor aligned to the International Scale – an important factor in helping to maintain consistency within and between laboratories to monitor patient progression toward remission.
The test is being released as a European CE IVD Mark product.
