Article
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January 07, 2026
TECH AND DISEASE TRENDS
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October 09, 2025
TECH AND DISEASE TRENDS
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The Need
The Philadelphia (Ph) chromosome is observed in patients with chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), and acute myeloid leukemia (AML).1
Guidelines recommend periodic monitoring of BCR::ABL 190 transcript as a significant predictor of relapse in Ph+ ALL and CML patients.2-4
Lack of international standard methods make comparison of BCR::ABL p190 quantification from laboratory-to-laboratory challenging.
Guidelines recommend periodic monitoring of BCR::ABL 190 transcript as a significant predictor of relapse in Ph+ ALL and CML patients.2-4
Lack of international standard methods make comparison of BCR::ABL p190 quantification from laboratory-to-laboratory challenging.
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 NCCN Guidelines for Patients Acute Lymphoblastic Leukemia, 2021
3 ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up of Acute Lymphoblastic Leukaemia
4 Canadian Cancer Society Follow-up after treatment for acute lymphocytic leukemia.
1502–1512 (2017)
2 NCCN Guidelines for Patients Acute Lymphoblastic Leukemia, 2021
3 ESMO Clinical Practice Guidelines for diagnosis, treatment, and follow-up of Acute Lymphoblastic Leukaemia
4 Canadian Cancer Society Follow-up after treatment for acute lymphocytic leukemia.
The Solution
The Xpert® BCR-ABL Ultra p190 is an automated test for quantifying the amount of BCR::ABL1 p190 transcript as a ratio of BCR::ABL p190/ABL1 with high sensitivity.7
Proprietary in-house RNA control materials are used to calibrate and standardize and align indirectly with the WHO IS (NIBSC-09/138) for BCR::ABL p210.6,7
6 Yuanyuan Liu, Tran Tran, Phat Nguyen, Huilin Wei, Gwo-Jen Day, Lin Yuan; Development of Reference Control Material for the Evaluation of the Cepheid Prototype * Xpert®
BCR-ABL P190 Ultra Assay. Blood 2019; 134 (Supplement_1): 5213
7 Xpert BCR-ABL Ultra Instructions for Use
BCR-ABL P190 Ultra Assay. Blood 2019; 134 (Supplement_1): 5213
7 Xpert BCR-ABL Ultra Instructions for Use
The Impact
- Monitor treatment response and Minimum Residual Disease (MRD) for Ph-positive (Ph+) ALL and CML patients.8
- Timely monitoring ensures the identification of high-risk patients associated with an inferior outcome to therapy.5
- Optimize lab organization with standardized reporting.6
5 Gandhe N, Vekaria M, Dabak V. A Rare Case of p190 BCR-ABL Chronic Myeloid Leukemia With a Very Good Response to Tyrosine Kinase Inhibitors. Cureus. 2021 Aug
5;13(8):e16914. doi: 10.7759/cureus.16914. PMID: 34513487; PMCID: PMC8418323.
6 Yuanyuan Liu, Tran Tran, Phat Nguyen, Huilin Wei, Gwo-Jen Day, Lin Yuan; Development of Reference Control Material for the Evaluation of the Cepheid Prototype * Xpert®
BCR-ABL P190 Ultra Assay. Blood 2019; 134 (Supplement_1): 5213
8 Soverini S, Bassan R, Lion T. Treatment and monitoring of Philadelphia chromosome-positive leukemia patients: recent advances and remaining challenges. J Hematol Oncol.
2019 Apr 23;12(1):39. doi: 10.1186/s13045-019-0729-2. PMID: 31014376; PMCID: PMC6480772.
5;13(8):e16914. doi: 10.7759/cureus.16914. PMID: 34513487; PMCID: PMC8418323.
6 Yuanyuan Liu, Tran Tran, Phat Nguyen, Huilin Wei, Gwo-Jen Day, Lin Yuan; Development of Reference Control Material for the Evaluation of the Cepheid Prototype * Xpert®
BCR-ABL P190 Ultra Assay. Blood 2019; 134 (Supplement_1): 5213
8 Soverini S, Bassan R, Lion T. Treatment and monitoring of Philadelphia chromosome-positive leukemia patients: recent advances and remaining challenges. J Hematol Oncol.
2019 Apr 23;12(1):39. doi: 10.1186/s13045-019-0729-2. PMID: 31014376; PMCID: PMC6480772.
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