Cepheid (NASDAQ: CPHD) today announced the release of an updated Xpert® BCR-ABL Monitor test, now incorporating 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."