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Xpert ® NPM1 Mutation
Xpert ® NPM1 Mutation is an automated test for quantifying the amount of mutant NPM1 mRNA transcripts (types A, B, and D in exon 12) as a ratio of NPM1 Mutation/ABL1 with high sensitivity.
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10 Tests
GXNPM1-CE-10
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The Need
Acute myeloid leukemia (AML), is the most common acute leukemia in adults. It represents about 80% of acute leukemia in adults, with a median age at diagnosis of 67-68 years.1-3Across European countries, the incidence is 3.5 cases per 100,000 population per year and the five-year survival is 17.5% approximately.1,3
Nucleophosmin (NPM1) is one of the most common genetic abnormalities in AML, accounting for about 30% to 35% ofcases.4-6The majority of NPM1 mutations in AML are restricted to exon-12 harboring type A (75% to 80%), type B (10%), and type D (5%) mutations.4,6,7
The determination of NPM1 mutation status has become essential for the molecular classification of AML. Methods with high clinical sensitivity and specificity adapted to the molecular laboratory workflow are required for the diagnosis, prognosis, and monitoring of AML.8Established international organizations recommend definitive timepoints for monitoring NPM1 in AML patients.9,10
Current testing options for NPM1 monitoring for AML patients are complicated, expensive, and time consuming. Due to the lack of International Standards for quantitation of the NPM1 mutation transcript for AML, laboratories are dependent on ratios and must run laborious standard curves.
Nucleophosmin (NPM1) is one of the most common genetic abnormalities in AML, accounting for about 30% to 35% ofcases.4-6The majority of NPM1 mutations in AML are restricted to exon-12 harboring type A (75% to 80%), type B (10%), and type D (5%) mutations.4,6,7
The determination of NPM1 mutation status has become essential for the molecular classification of AML. Methods with high clinical sensitivity and specificity adapted to the molecular laboratory workflow are required for the diagnosis, prognosis, and monitoring of AML.8Established international organizations recommend definitive timepoints for monitoring NPM1 in AML patients.9,10
Current testing options for NPM1 monitoring for AML patients are complicated, expensive, and time consuming. Due to the lack of International Standards for quantitation of the NPM1 mutation transcript for AML, laboratories are dependent on ratios and must run laborious standard curves.
- Bocchia M, Carella AM, Mulè A, Rizzo L, Turrini M, Abbenante MC, Cairoli R, Calafiore V, Defina M, Gardellini A, Luzi G, Patti C, Pinazzi MB, Riva M, Rossi G, Sammartano V, Rigacci L. Therapeutic Management of Patients with FLT3 + Acute Myeloid Leukemia: Case Reports and Focus on Gilteritinib Monotherapy. Pharmgenomics Pers Med. 2022 Apr 22;15:393-407. doi: 10.2147/PGPM.S346688. PMID: 35496349; PMCID: PMC9041600.
- De Kouchkovsky, I., Abdul-Hay, M. ‘Acute myeloid leukemia: a comprehensive review and 2016 update’. Blood Cancer Journal 6, e441 (2016). https://doi.org/10.1038/bcj.2016.50
- Acute Myeloid Leukaemia: mapping the policy response to an acute cancer in France, Germany, Italy, Spain and the UK, The Economist Intelligence Unit Limited, December 2019.
- The Leukemia & Lymphoma Society®. Acute Myeloid Leukemia Subtypes. https://www.lls.org/leukemia/acute-myeloid-leukemia/diagnosis/aml-subtypes
- Kunchala P, Kuravi S, Jensen R, McGuirk J, Balusu R. When the good go bad: Mutant NPM1 in acute myeloid leukemia. Blood Rev. 2018; 32(3): 167-183. doi:10.1016/j.blre.2017.11.001
- A. Behdad, B.L. Betz, Chapter 33 - Molecular Testing in Acute Myeloid Leukemia,Diagnostic Molecular Pathology, Academic Press, 2017, Pages 419-434,ISBN 9780128008867,https://doi.org/10.1016/B978-0-12-800886-7.00033-9
- Szankasi P, Jama M, Bahler DW. A new DNA-based test for detection of nucleophosmin exon 12 mutations by capillary electrophoresis. J Mol Diagn. 2008 May;10(3):236-41. doi: 10.2353/jmoldx.2008.070167. Epub 2008 Apr 10. PMID: 18403605; PMCID: PMC2329788.
- Hafez M, Ye F, Jackson K, Yang Z, Karp JE, Labourier E, Gocke CD. Performance and clinical evaluation of a sensitive multiplex assay for the rapid detection of common NPM1 mutations. J Mol Diagn. 2010 Sep;12(5):629-35. doi: 10.2353/jmoldx.2010.090219. Epub 2010 Jul 8. PMID: 20616361; PMCID: PMC2928427.
- Heuser M, Ofran Y, Boissel N, Brunet Mauri S, Craddock C, Janssen J, Wierzbowska A, Buske C. Acute myeloid leukemia in adult patients: ESMO Clinical Oractice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, Special Article, Vol. 31, Issue 6, June 2020, Pages 697-712. doi: https://doi.org/10.1016/j.annonc.2020.02.018
- National Comprehensive Cancer Network. NCCN Guidelines for Patients – Acute Myeloid Leukemia, 2022. https://www.nccn.org/patients/guidelines/content/PDF/aml-patient.pdf. Accessed on January 11, 2023.
The Solution
Xpert ® NPM1 Mutation is an automated test for quantifying the amount of mutant NPM1 mRNA transcripts (types A, B, and D in exon 12) as a ratio of NPM1 Mutation/ABL1.
Leveraging Cepheid’s lab in a cartridge™ technology, the Xpert NPM1 Mutation test decreases workflow complexity and hands-on time by automating the entire testing process and delivering faster results in one fully automated cartridge.
Benefits:
Leveraging Cepheid’s lab in a cartridge™ technology, the Xpert NPM1 Mutation test decreases workflow complexity and hands-on time by automating the entire testing process and delivering faster results in one fully automated cartridge.
Benefits:
- ≤3 hours total testing process
- Simply add treated blood sample and an off-board reagent to the Xpert ® cartridge to initiate a test
- 4 mL input volume of peripheral blood (EDTA whole blood)
- Includes two internal controls
- High sensitivity and low inter-laboratory variation11
- Clinically demonstrated limit of detection of 0.030%11
11. Xpert® NPM1 Mutation Instructions for Use (part number 302-8304)
The Impact
Patient: Convenience of testing and fast results could help reduce patient anxiety - Relapse remains the most common cause of treatment failure for AML patients.12
Clinician: Timely NPM1 monitoring results support informed decisions - Ensures measurement of treatment response and detection of potential relapse.8
Laboratory: Easy to use CE-IVD cleared test with flexibility and standardization for optimized testing workflow.
Clinician: Timely NPM1 monitoring results support informed decisions - Ensures measurement of treatment response and detection of potential relapse.8
Laboratory: Easy to use CE-IVD cleared test with flexibility and standardization for optimized testing workflow.
- Process any number of samples, any day of the week, with a fixed cost per reportable result, no wasted time, or reagents from batching requirements
- Automated processing provides consistent data, decreases costs by eliminating standard curve and replicating testing requirements, allowing optimized lab organization by freeing up technician time for other lab activities
- Proprietary in-house RNA control materials are used to calibrate and standardize each lot of the Xpert NPM1 Mutation test.13
8. Hafez M, Ye F, Jackson K, Yang Z, Karp JE, Labourier E, Gocke CD. Performance and clinical evaluation of a sensitive multiplex assay for the rapid detection of common NPM1 mutations. J Mol Diagn. 2010 Sep;12(5):629-35. doi: 10.2353/jmoldx.2010.090219. Epub 2010 Jul 8. PMID: 20616361; PMCID: PMC2928427.
12. Dillon R, Hills R, Freeman S, Potter N, Jovanovic J, Ivey A, Kanda AS, Runglall M, Foot N, Valganon M, Khwaja A, Cavenagh J, Smith M, Ommen HB, Overgaard UM, Dennis M, Knapper S, Kaur H, Taussig D, Mehta P, Raj K, Novitzky-Basso I, Nikolousis E, Danby R, Krishnamurthy P, Hill K, Finnegan D, Alimam S, Hurst E, Johnson P, Khan A, Salim R, Craddock C, Spearing R, Gilkes A, Gale R, Burnett A, Russell NH, Grimwade D. Molecular MRD status and outcome after transplantation in NPM1-mutated AML. Blood. 2020 Feb 27;135(9):680-688. doi: 10.1182/blood.2019002959. PMID: 31932839; PMCID: PMC7059484.
13. Liu, Y. Kao, M. Saatian, B. Kayhan, S. Zhao, Y. Aslam, A. Shridhar, K. Yuan, L. PB1775: DEVELOPMENT OF ASSAY CALIBRATION MEHTHODOLOGY FOR CEPHEID XPERT® NPM1 MUTATION PROTOTYPE ASSAY. HemaSphere 6():p 1655-1656, June 2022. | DOI: 10.1097/01.HS9.0000849952.50330.40
*CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
12. Dillon R, Hills R, Freeman S, Potter N, Jovanovic J, Ivey A, Kanda AS, Runglall M, Foot N, Valganon M, Khwaja A, Cavenagh J, Smith M, Ommen HB, Overgaard UM, Dennis M, Knapper S, Kaur H, Taussig D, Mehta P, Raj K, Novitzky-Basso I, Nikolousis E, Danby R, Krishnamurthy P, Hill K, Finnegan D, Alimam S, Hurst E, Johnson P, Khan A, Salim R, Craddock C, Spearing R, Gilkes A, Gale R, Burnett A, Russell NH, Grimwade D. Molecular MRD status and outcome after transplantation in NPM1-mutated AML. Blood. 2020 Feb 27;135(9):680-688. doi: 10.1182/blood.2019002959. PMID: 31932839; PMCID: PMC7059484.
13. Liu, Y. Kao, M. Saatian, B. Kayhan, S. Zhao, Y. Aslam, A. Shridhar, K. Yuan, L. PB1775: DEVELOPMENT OF ASSAY CALIBRATION MEHTHODOLOGY FOR CEPHEID XPERT® NPM1 MUTATION PROTOTYPE ASSAY. HemaSphere 6():p 1655-1656, June 2022. | DOI: 10.1097/01.HS9.0000849952.50330.40
*CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries.
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