Legacy ALL Fusion Panel

Alternative Name Philadelphia – like acute lymphoblastic leukemia (Ph-Like ALL)

Methodology Molecular

Test Description Detection of fusion transcripts in Acute Lymphoblastic Leukemia (ALL) from ribonucleic acid (RNA). RNA is isolated from bone marrow aspirates or peripheral blood and the cDNA sequence of targeted regions of the ABL1, ABL2, BCR, CRLF2, CSF1R, ETV6, IL2RB, IL3, JAK2, KMT2A, MEF2D, MLLT10, NUP98, PAX5, PDGFRB, PTK2B, RUNX1 ,TAL1, TCF3, TLX1, TLX3, TYK2, and ZNF384 is determined using next-generation sequencing (NGS) technology. This test will be performed at our Carlsbad location.

For comprehensive Ph-like ALL assessment consider ordering CRLF2 FISH & EPOR FISH concurrently. See also the ALL FISH PROFILE (Ph-Like)

Clinical Significance Diagnostic Evaluation, Risk Assessment and Therapy Selection

Chromosome aberrations, in particular translocations and the corresponding gene fusions, have an important role in the initial steps of tumorigenesis.1 The identification of gene fusions in B Cell Acute Lymphoblastic Leukemia (B-ALL) are being recognized as an essential part of the diagnostic evaluation, risk assessment and optimal therapy selection.[2,3] Within B- ALL, three major groups of fusions/rearrangements have been identified.

BCR-ABL1 (aka Philadelphia “Ph+”)[1-3] Ph-Like (WHO 2016 Entity)[1-5] ABL-class fusions: BCR, ABL1, ABL2, CSFR1, PDGFR-? EPOR or JAK2 fusions Cytokine -like factor 2 (CRLF2) fusions Other Ph-Like fusions [6,7] B ALL: DUX4, ETV6, IL2RB, KMT2A(MLL), MEF2D, MLLT10, NUP98, PAX5, PTK2B, RUNX1, TCF3, TSLP, TYK2, ZNF384 T ALL: TAL1, TLX1, TLX3

Specimen Requirements Preferred:

Peripheral blood: 2-3 mL in EDTA (purple-top) tube Bone marrow: 2-3 mL in EDTA (purple-top) tube

Acceptable:

Peripheral blood: 2-3 mL in sodium heparin (green-top) tube Bone marrow: 2-3 mL in in sodium heparin (green-top) tube Fixed cell pellets (3:1 methanol and acetic acid fixative)

Storage & Transportation Use cold pack for transport. Make sure cold pack is not in direct contact with specimen. DO NOT FREEZE.

CPT Code(s)* 81450x1, add 88377x2 if FISH is ordered.

New York Approved Yes

Level of Service Global

Turnaround Time 15 days (NGS), 6 days (FISH)

References 1. Mitelman F, et al. The impact of translocations and gene fusions on cancer causation. Nature Reviews Cancer. 7, 233- 245 | doi:10.1038/nrc2091. 2. NCCN Practice Guidelines in Oncology, Acute Lymphoblastic Leukemia--Version 1.2017. Accessed on 8/28/2017. 3. Roberts KG, et al. Targetable Kinase-Activating Lesions in Ph-like Acute Lymphoblastic Leukemia. N Engl J Med. 2014;371:1005-15. 4. Yokota T, et al. Genetic abnormalities associated with acute lymphoblastic leukemia. Cancer Sci. 107 (2016) 721–725. 5. Arber, DA. et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016; 127(20):2391-2405. 6. Roberts, KG, et al. High Frequency and Poor Outcome of Philadelphia Chromosome–Like Acute Lymphoblastic Leukemia in Adults. Journal of Clinical Oncology. 35:394-401. 7. Iacobucci I, et al. Genetic Basis of Acute Lymphoblastic Leukemia. J Clin Oncol. 35:975-983.

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

Test of | September 28, 2021 © 2021 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest technologies, testing partnership opportunities, and interactive education to the oncology and pathology communities. We offer the complete spectrum of diagnostic services in molecular testing, FISH, cytogenetics, flow cytometry, and immunohistochemistry through our nation-wide network of CAP-accredited, CLIA-certified laboratories.

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*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party.

Please direct any questions regarding coding to the payor being billed.

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