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The intended use of this multi-gene genomic panel is in patients with myeloproliferative neoplasms (MPN), myelodysplastic syndrome (MDS), and acute myelogenous leukemia (AML). These disorders are clonal disorders of hematopoietic stem cells and share clinicopathologic features and underlying molecular drivers. Emerging evidence supports the clinical value of simultaneous detection of somatic mutations in multiple genes as markers for neoplastic clonal populations to guide 1) diagnosis, 2) prognostic risk assessment, 3) therapeutic options, and 4) monitoring of minimal residual disease (MRD).
The sensitivity of this assay is 5 to 10% variant allele fraction for single nucleotide variants (SNV) and insertion/deletions (InDels). This assay can detect whole-gene copy number alterations (CNAs) of 25% or greater. Mutations outside the targeted regions and gene rearrangements will not be detected. Clinical significance of variants is classified following a joint consensus recommendation from the AMP, ASCO and CAP. Results should be interpreted in conjunction with clinical and other laboratory findings for the most accurate interpretation.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).
IntelliGEN® Myeloid utilizes amplicon-based next generation sequencing to identify alterations in 50 genes that have diagnostic, prognostic, and therapeutic significance in myeloid neoplasms.
Whole blood, bone marrow, cell pellets from whole blood, or cell pellets from bone marrow
3-5 mL (Blood), 1-2 mL (Bone Marrow)
3 mL (Blood), 1 mL (Bone Marrow)
Causes for Rejection
Specimen does not meet criteria for sample type, container, minimum volume, collection and storage; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed specimen or otherwise visibly degraded; contaminated specimen; contains suspicious foreign material
This assay is not approved for patients of New York State physicians.