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Xpert® BCR-ABL Ultra p190
Sensitive and quantitative monitoring of BCR-ABL p190 and ABL mRNA in patients with chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL)
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GXBCRABLP190-CE-10
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The Need
The ongoing presence of the Ph chromosome in ALL patients after consolidation therapy is a significant predictor of relapse, and monitoring is recommended. Established international organizations recommend definitive timepoints for monitoring BCR-ABL p190 in ALL and CML patients.7-10 Unlike the BCR-ABL World Health Organization international standard (WHO IS) for the p210 transcript, currently, there are no international standards that can be used to standardize the p190 fusion transcriptCurrent testing options for BCR-ABL p190 monitoring for both CML and ALL patients are not only cumbersome, but can be expensive and time consuming for the lab to implement because:
- Available testing methods can be complex and create inefficient laboratory workflows.
- No international scale has been established for p190 monitoring, so laboratories are dependent on ratios and must run laborious standard curves.
(1)Reckel, S., Hamelin, R., Georgeon, S. et al. Differential signaling networks of Bcr–Abl p210 and p190 kinases in leukemia cells defined by functional proteomics. Leukemia 31, 1502–1512 (2017)
(2)Faderl S. et al. Clinical Significance of Cytogenic Abnormalities in Adult Acute Lymphoblastic Leukemia. Blood.1998; 91 (11): 3995-4019.
(3)Dushyant, V. et al. Chronic myeloid leukemia (CML) with p190 BCR-ABL: analysis and characteristics, outcomes and prognostic significance. Blood. 2009; 114: 2232-2235.
(4)Moorman, A. V. et al. A population-based cytogenetic study of adults with acute lymphoblastic leukemia. Blood 2010; 115:206-214.
(5)Burmeister, T. et al. Patient’s age and BCR-ABL frequency in adult B-precursor ALL: A retrospective analysis from the GMALL study group. Blood. 2008; 112:918-919.
(6)NCCN Clinical Practice Guidelines in Oncology Acute Lymphoblastic Leukemia v2.2019.
(7)NCCN Guidelines for Patients Acute Lymphoblastic Leukemia, 2021
(8)ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up of Acute Lymphoblastic Leukaemia
(9)Canadian Cancer Society Follow-up after treatment for acute lymphocytic leukemia.
(10)Foroni L, Wilson G, Gerrard G, Mason J, Grimwade D, White HE, de Castro DG, Austin S, Awan A, Burt E, Clench T, Farruggia J, Hancock J, Irvine AE, Kizilors A, Langabeer S, Milner BJ, Nickless G, Schuh A, Sproul A, Wang L, Wickham C, Cross NC. Guidelines for the measurement of BCR-ABL transcripts in chronic myeloid leukaemia. Br J Haematol. 2011 Apr;153(2):179-90.
(2)Faderl S. et al. Clinical Significance of Cytogenic Abnormalities in Adult Acute Lymphoblastic Leukemia. Blood.1998; 91 (11): 3995-4019.
(3)Dushyant, V. et al. Chronic myeloid leukemia (CML) with p190 BCR-ABL: analysis and characteristics, outcomes and prognostic significance. Blood. 2009; 114: 2232-2235.
(4)Moorman, A. V. et al. A population-based cytogenetic study of adults with acute lymphoblastic leukemia. Blood 2010; 115:206-214.
(5)Burmeister, T. et al. Patient’s age and BCR-ABL frequency in adult B-precursor ALL: A retrospective analysis from the GMALL study group. Blood. 2008; 112:918-919.
(6)NCCN Clinical Practice Guidelines in Oncology Acute Lymphoblastic Leukemia v2.2019.
(7)NCCN Guidelines for Patients Acute Lymphoblastic Leukemia, 2021
(8)ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up of Acute Lymphoblastic Leukaemia
(9)Canadian Cancer Society Follow-up after treatment for acute lymphocytic leukemia.
(10)Foroni L, Wilson G, Gerrard G, Mason J, Grimwade D, White HE, de Castro DG, Austin S, Awan A, Burt E, Clench T, Farruggia J, Hancock J, Irvine AE, Kizilors A, Langabeer S, Milner BJ, Nickless G, Schuh A, Sproul A, Wang L, Wickham C, Cross NC. Guidelines for the measurement of BCR-ABL transcripts in chronic myeloid leukaemia. Br J Haematol. 2011 Apr;153(2):179-90.
The Solution
Xpert BCR-ABL Ultra p190 is an automated test for quantifying the amount of BCR-ABLp190 transcript as a ratio of BCR-ABL p190/ABLwith high sensitivity.
Based on the innovative GeneXpert® technology, Xpert BCR-ABL Ultra p190 automates the testing procedure, including RNA isolation, reverse transcriptionLeveraging Cepheid's lab in a cartridge™ technology, the Xpert BCR-ABL p190 test decreases workflow complexity and hands-on time by automating the entire testing process, delivering faster results.
Xpert BCR-ABL Ultra p190 is a quantitative test for the BCR-ABL minor breakpoint (p190) transcripts that provide high test sensitivity, standardization, and on-demand molecular results in ≤2.5 hours. With minimal hands-on time and a streamlined workflow, Xpert BCR-ABL Ultra p190 eliminates the need for time-consuming hands-on processes and enables the laboratory to run p190 testing in-house.
Performance:
Simple & Easy to Use
Based on the innovative GeneXpert® technology, Xpert BCR-ABL Ultra p190 automates the testing procedure, including RNA isolation, reverse transcriptionLeveraging Cepheid's lab in a cartridge™ technology, the Xpert BCR-ABL p190 test decreases workflow complexity and hands-on time by automating the entire testing process, delivering faster results.
Xpert BCR-ABL Ultra p190 is a quantitative test for the BCR-ABL minor breakpoint (p190) transcripts that provide high test sensitivity, standardization, and on-demand molecular results in ≤2.5 hours. With minimal hands-on time and a streamlined workflow, Xpert BCR-ABL Ultra p190 eliminates the need for time-consuming hands-on processes and enables the laboratory to run p190 testing in-house.
Performance:
Simple & Easy to Use
- ≤2.5 hours total testing process
- Simply add treated blood sample and an off-board reagent to the Xpertcartridge
- Includes two internal controls
- 4 mL input volume of EDTA whole blood supports high test sensitivity for detection of low-level transcripts
- High sensitivity and low inter-laboratory variation11
- Clinically demonstrated limit of detection of 0.0065%11
(11)Xpert® BCR-ABL Ultra p190 Instructions for Use (part number 302-6673)
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