IntelliGEN® Myeloid

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Test Details

Use

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).

Limitations

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).

Methodology

IntelliGEN® Myeloid utilizes amplicon-based next generation sequencing to identify alterations in 50 genes that have diagnostic, prognostic, and therapeutic significance in myeloid neoplasms.

Specimen Requirements

Specimen

Whole blood, bone marrow, cell pellets from whole blood, or cell pellets from bone marrow

Volume

3-5 mL (Blood), 1-2 mL (Bone Marrow)

Minimum Volume

3 mL (Blood), 1 mL (Bone Marrow)

Container

Lavender-top (EDTA) tube or green-top (heparin) tube

Storage Instructions

Refrigerate

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

Clinical Information

Special Instructions

This assay is not approved for patients of New York State physicians.

For Providers

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© 2018  Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.

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