Xpert BCR-ABL Monitor

Now Aligned to the World Health Organization’s BCR-ABL Standards with Every Lot
 "Cepheid's Xpert^® BCR-ABL Monitor test is a powerful tool for monitoring patients being treated for Chronic Myelogenous Leukemia. The unsurpassed sensitivity of the GeneXpert^® System enables clinicians to process molecular tests in their own facilities instead of sending patient samples to a central lab and waiting for results. A patient's local clinician can now monitor minimal disease levels very quickly - the key to appropriately managing patients who may be at risk for relapse."
- Dr. Ellie Nacheva, MD PhD FRCPath
Head of Lab - Leukemia Cytogenetics,
Royal Free and University College School of Medicine


Runs On: GeneXpert^® System

The Need

Current Guidelines:
Current practice guidelines from Europe Against Cancer and National Comprehensive Cancer Network (NCCN) for management of patients with CML call for use of quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) assays during the initial workup of patients with chronic phase CML, in monitoring for minimal residual disease, and in identifying patients who may be at a high risk for relapse.

RT-PCR:
RT-PCR has been shown to be an accurate and highly sensitive method for detection of the BCR-ABL fusion gene, and is more sensitive than Fluorescence In Situ Hybridization (FISH) or cytogenetics.

An additional advantage of quantitative PCR versus FISH and cytogenetics is the high correlation of PCR results obtained from bone marrow and peripheral blood samples. Therefore, PCR may potentially reduce the bone marrow aspirations currently required in patients with CML.

International Standardization:
The clinical utility of monitoring BCR-ABL mRNA levels has become standard of care in aiding physicians in managing their CML patients. Therefore, it is essential that variation between and within laboratories remain low.

The Solution

Xpert BCR-ABL Monitor:
Xpert BCR-ABL is a real-time RT-PCR (Reverse Transcription Polymerase Chain Reaction) test intended as an aid in the monitoring of the p210 BCR-ABL translocation in peripheral blood lymphocytes (PBL) of patients with chronic myelogenous leukemia (CML). This revolutionary test offers unique features not available in current testing methods, including: minimal hands-on time while delivering answers in less than 2 hours.

The GeneXpert System:
The GeneXpert is the only system to combine sample preparation with real time PCR amplification and detection for fully integrated and automated nucleic acid analysis. The system purifies, concentrates, detects, and identifies targeted nucleic acid sequences in less than 2 hours. The GeneXpert System requires minimal hands on time. For BCR-ABL, after a short sample preparation step users simply add selected reagents and the prepared sample to the cartridge and the GeneXpert System does the rest.

GeneXpert BCR-ABL/ABL Monitor Test (IS)
Xpert BCR-ABL/ABL test reports results to the International Scale by using an assay-specific conversion factor determined by comparison to an IS reference assay. Reporting to the International scale gives reliable and consistent results allowing physicians to better manage their patients and facilitating assessment of a major molecular response (MMR=3 log reduction from the IS baseline).