Reanalysis of Acute Myeloid Leukemia 4- or 11- Gene Panels, Additional Genes

Casandra

Casandra Test Code MC68084Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID NGSFXCPT Code 81450

Reanalysis of Acute Myeloid Leukemia 4- or 11- Gene Panels, Additional Genes

Clinical Use

Use

Comprehensive reanalysis of a larger set of genes/gene regions when a more targeted gene panel was previously performed in this laboratory. Evaluation of known or suspected hematologic neoplasms, specifically of myeloid origin (eg, acute myeloid leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myelodysplastic/myeloproliferative neoplasm, unexplained cytopenias) at the time of diagnosis or possibly disease relapse, to help determine diagnostic classification and provide prognostic or therapeutic information for helping guide clinical management. Determine the presence of new clinically important gene mutation changes at relapse.

Special Instructions

Only orderable as a reflex. Reflex testing is available upon request within 6 months of original NGAMT / MayoComplete Acute Myeloid Leukemia, Therapeutic Gene Mutation Panel (FLT3, IDH1, IDH2, TP53), Next Generation Sequencing, Varies or NGAML / MayoComplete Acute Myeloid Leukemia, 11-Gene Panel, Varies sample submission. This is a bioinformatics review of additional gene regions not analyzed in the previously ordered tests.

Limitations

This test will not detect genetic abnormalities in genes or regions outside the specified target areas. The test detects single base substitutions (ie, point mutations) as well as small insertion or deletion type events, but does not detect gene rearrangements (ie, translocations), gene fusions, copy number alterations, or large scale (segmental chromosome region) deletions and complex changes. This assay does not distinguish between somatic and germline alterations, particularly with variant allele frequencies near 50% or 100%. A low incidence of gene mutations associated with myeloid neoplasms can be detected in nonmalignant hematopoietic cells in individuals with advancing age (clonal hematopoiesis of indeterminate potential), and these may not be clearly distinguishable from tumor-associated mutations. Prior treatment for hematologic malignancy could affect results obtained in this assay, especially following an allogeneic hematopoietic stem cell transplant.

Test Details

New York Approved

Methodology

NGS (Targeted)

Biomarkers

Mutation (47 genes)

ANKRD26ASXL1BCORBCORL1BRAFCALRCBLCEBPACSF3RDDX41DNMT3AELANEETNK1ETV6EZH2FLT3GATA1GATA2IDH1IDH2JAK2KDM6AKITKRASMPLNF1NPM1NRASPHF6PPM1DPTPN11RAD21RUNX1SETBP1SH2B3SF3B1SMC3SRSF2STAG2STAT3TERTTET2TP53U2AF1UBA1WT1ZRSR2