Updated Xpert BCR-ABL Monitor Test Released by Cepheid

Cepheid has released an updated Xpert BCR-ABL Monitor test, which now incorporates lot-specific standardization using the WHO (World Health Organization) BCR-ABL standards. The test is being released as a European CE-IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test, which runs on Cepheid's GeneXpert System, detects the BCR-ABL mRNA transcript in the peripheral blood of patients with Chronic Myelogenous Leukemia (CML) in about two hours.

"Our work in the CML area is the first of several initiatives we are developing as we extend the GeneXpert System test menu into a new line of molecular diagnostic oncology products," said John Bishop, Cepheid's Chief Executive Officer. "The new lot-specific standardization translates to even greater clinical accuracy for physicians as they compare BCR-ABL values over time within the same patient, as well as comparability across geographic locations where testing is being performed."

"We have used and endorsed Xpert BCR-ABL Monitor in our research efforts for several years," commented Dr. Jerald Radich, head of the Molecular Oncology Lab at the Fred Hutchinson Cancer Research Center. "Lot-to-lot standardization to the WHO benchmark improves reliability and comparability between labs. This will facilitate both patient care and clinical research studies which rely on BCR-ABL testing as a benchmark of response."

CML is a cancer of the myeloid lineage of leukocytes (white blood cells) that is characterized by the presence of the "Philadelphia Chromosome," a reciprocal translocation of chromosomes 9 and 22 that results in the generation of the BCR-ABL fusion gene. The BCR-ABL protein functions as a constitutively activated tyrosine kinase that drives the proliferation of immature myeloid cells.

If untreated, CML progresses within several years from a chronic phase to accelerated phase or blast crisis, where survival is often measured in months. The introduction of the targeted Tyrosine Kinase Inhibitors (TKIs) imatinib, dasatanib, and nilotinib has had a profound impact on the survival of patients with CML. Since their introduction, CML has been transformed into a chronic condition with a good long-term prognosis. Monitoring the levels of BCR-ABL mRNA transcript in the blood of CML patients on TKIs using real-time quantitative PCR has become standard of care in the management of CML. The goal of treatment is to reach a major molecular response (MMR), defined as a 3 log reduction (< 0.1%) in BCR-ABL mRNA levels from a standardized baseline as defined by the International Scale. In order to accurately assess treatment response, it is essential that variability in testing methodologies be tightly controlled. This has resulted in substantial efforts to standardize BCR-ABL molecular testing across laboratories by introducing an International Scale.

Cepheid has now enhanced this validation effort by controlling variation between each lot of manufactured product. The updated Xpert BCR-ABL Monitor, with lot-specific standardization, is now available as a CE-IVD Mark product. For more information on Cepheid's GeneXpert Systems or complete menu of CE-IVD Xpert tests, click on the ‘request information’ tab below.