test with confidence using Cepheid oncology molecular diagnostics.
Xpert® BCR-ABL Ultra
Easy, Sensitive and 'On Demand' Measurement of BCR-ABL p210 Transcript Levels for CML Monitoring
Quantitative RT-PCR Monitoring
Monitoring Results You Can Trust
Once therapy has commenced, guidelines support the use of real-time quantitative polymerase chain reaction (RT-qPCR) testing to accurately track the BCR-ABL1 transcripts with high sensitivity.
Quantitative reverse transcription PCR becomes vitally important in monitoring the efficacy of CML treatment.10
Xpert® BCR-ABL Ultra runs on a fully integrated GeneXpert® System and testing process by carrying out RNA isolation, reverse transcription, and fully-nested real-time PCR, in an automated cartridge.
Disease Detection at Low Levels
Cepheid's Xpert® BCR-ABL Ultra demonstrates a limit of detection down to MR4.52 (BCR-ABL1 IS 0.0030%IS) giving confidence in measuring a deep molecular response (DMR).
A 4mL blood sample from a CML patient ensures reproducible detection of low-level BCR-ABL1 transcripts while adhering to recommended guidelines for monitoring response to TKI therapy.13
Figure 1.0 Illustrates the levels of molecular response in CML as standardized by the International Scale (IS).20
Results on the International Standard Without Additional Work
Treatment decisions are directly influenced by CML monitoring results. This makes the sensitivity of a BCR-ABL1 test crucial for patient management, particularly for patients who achieve a deep molecular response.16
The quantitative results for Cepheid's Xpert® BCR-ABL Ultra test are normalized against the reference gene ABL and converted to the International Scale (IS) via secondary standards derived from the World Health Organization standards. All this is performed for each lot of the test and by Cepheid such that no end user calculations are required to gain results on the %IS.
Xpert BCR-ABL Ultra Package Insert, US-IVD, 302-0738, Rev. A
Shorten Time to Results
Time is precious, make it count
15 days? 3 weeks? 3 hours?
Xpert® BCR-ABL Ultra provides CML monitoring results in less than 2.5 hours supporting informed clinical decisions.
The reduction in wait time for CML monitoring results is a consequence of a shortened testing process that streamlines the laboratory workflow.
Figure 1.1 Shows a comparison of time between a manual in-house assay and Xpert BCR-ABL Ultra.18,19
Perform Your CML Monitoring Tests When it Best Fits Your Schedule
Xpert® BCR-ABL Ultra runs on a fully integrated GeneXpert® System that is automated for on-demand monitoring. Cepheid’s integrated platform and test reduce the long wait time to batch extract samples so that processing a patient’s blood upon arrival becomes a possibility.
Figure 1.2 Highlights the steps required to prepare and load the assay and run the test on Cepheid’s GeneXpert System.
Built in Controls Ensuring Confidence in All Results
All tests, including the Xpert BCR-ABL Ultra Test, contain internal quality controls, meaning every patient sample is controlled independently.17
Sample Processing Control - controls the sample processing steps (e.g. lysis and extraction) and preserves the integrity of the nucleic acid and reagent bead rehydration
Amplification Control - detects enzyme integrity and possible PCR inhibition
Reagent Controls - checks the integrity of the probes and proper reconstitution of reagents
Instrument System Control - validates optics, temperature of the module and mechanical integrity17
28 Tests. 1 Platform, Consolidation to Bring Cost-Efficiency.*
Xpert® BCR-ABL Ultra is one of many tests that run on the GeneXpert family of systems. Each individual test cartridge automates sample extraction, amplification, and detection within the GeneXpert System, which is available in a variety of sizes to suit differing laboratory requirements and situations.