SUNNYVALE, Calif. — Cepheid (CPHD) today announced the release of an updated Xpert® BCR-ABL Monitor test, now reporting results to the International Scale. 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 updated Xpert BCR-ABL Monitor test incorporates a fully validated test-specific conversion factor aligned to the International Scale — an important factor in helping to maintain consistency within and between laboratories to more accurately monitor patient progression toward remission.”

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 and blastic phases, with survival in the blastic phase 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 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 defined by the International Scale(1,2). 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(3). The updated Xpert BCR-ABL Monitor is now available as a CE IVD Mark product. For more information, visit www.cepheidinternational.com for Cepheid’s complete menu of CE IVD Xpert tests.