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Xpert® BCR-ABL Ultra

Xpert® BCR-ABL Ultra

Xpert® BCR-ABL Ultra

Product catalog summary
Introduction
The document discusses the Xpert® BCR-ABL Ultra, an in vitro diagnostic medical device designed for ultra-sensitive monitoring of Chronic Myelogenous Leukemia (CML). It highlights the increasing prevalence of CML and the need for improved molecular testing to enhance patient outcomes.

The Need
Each year, 1.0-1.5 new CML cases are diagnosed per 100,000 individuals, with prevalence expected to double by 2030. Current management involves Tyrosine Kinase Inhibitors (TKIs) and requires regular molecular diagnostic assays to measure BCR-ABL transcript levels. However, only one-third of patients are adequately monitored in the first year, indicating a need for more accessible testing.

The Solution
The Xpert BCR-ABL Ultra test offers a quantitative assessment of BCR-ABL transcripts with high sensitivity and ease of use. It automates the entire testing process, providing results in less than 2.5 hours. The test uses a 4 mL blood sample and aligns results to the International Scale (IS) for consistent reporting.

Performance and Impact
The test demonstrates high sensitivity with a clinically proven detection limit of less than a 4.5-log reduction. It supports same-day clinical decisions, reduces patient anxiety, and streamlines laboratory workflows. The test eliminates the need for standard curves and replicate testing, reducing costs and freeing up technician time.

Clinical Evaluation
The Xpert BCR-ABL Ultra was compared with an in-house assay, showing comparable performance with reduced hands-on time and process steps. The assay's convenience and medical value are highlighted by its quick processing time and minimal procedural requirements.

Conclusion
The Xpert BCR-ABL Ultra provides a reliable, efficient, and sensitive method for monitoring CML, addressing current challenges in patient management and laboratory efficiency.
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Catalog excerpts

Xpert® BCR-ABL Ultra-1

Xpert BCR-ABL Ultra ® Xpert BCR-ABL Ultra ® Sensitivity, precision and ease of use In Vitro Diagnostic Medical Device

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Xpert® BCR-ABL Ultra-2

Cepheid’s Xpert BCR-ABL Ultra test solves many of the present challenges in monitoring patients with Chronic Myeloid Leukaemia, including accuracy (remarkably precise International Scale calibration) and speed (in hours) of reporting molecular response. These performance characteristics are important from initiation of therapy to the deep remissions possible with the array of available therapeutic options." Leader, Myeloproliferative Neoplasms Program. Memorial Sloan Kettering Cancer Center THE SOLUTION Each year 1.0-1.5 newly diagnosed Chronic Myelogenous Leukaemia (CML) patients are identified...

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Xpert® BCR-ABL Ultra-3

THE IMPACT • Clinician: Same day information supports informed clinical decisions, including inclusion in treatment discontinuation research • Patient: Faster results reduce patient anxiety9 • Laboratory: Flexibility and simplicity for more streamlined workflow Move your lab forward • Decrease costs: Eliminates need for standard curve and replicate testing • Optimised lab organisation: Free up technician time for other lab services • Flexible: Any number of samples, any day of the week with a fixed cost per reportable result • Simple Reporting: One page report with results aligned to the IS PROCESS...

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Xpert® BCR-ABL Ultra-4

Easy Same-Day Process 1 Transfer the Wash Reagent into Chamber 1 Pipette entire contents of prepared sample (~4.5mL) into the sample chamber (S) 3 Insert cartridge and start test Xpert® BCR-ABL Ultra provides individual on-demand measurement of BCR-ABL transcript levels down to 4.5 log reduction for individuals with CML. Xpert BCR-ABL Ultra CATALOG INFORMATION References: 1. Goldman J. Chronic Myeloid Leukemia. 2008, Leukemia, Vol. 37, pp. 195-197. 2. Huang X, et al. Estimations of the increasing prevalence and plateau prevalence of chronic myeloid leukemia in the era of tyrosine kinase inhibitor...

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