IntelliGEN® Myeloid

CPT: 81450
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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). Insertions and deletions of any length are detected when at least one breakpoint is contained within an amplicon. Insertions up to 126 bp and deletions up to 52 bp have been detected in clinical specimens. 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. Variants are categorized into Tiers based on their clinical impact, following a joint consensus recommendation from the AMP, ASCO, and CAP. Clinical and experimental evidence grouped into four levels (A-D) based on significance in clinical decision making (therapeutic, diagnosis, prognosis) is assigned to variants to determine their clinical significance. Tier 1, Variants with Strong Clinical Significance (level A and B evidence); Tier 2, Variants with Potential Clinical Significance (level C or D evidence); Tier 3, Variants of Unknown Clinical Significance, and Tier 4, Benign or Likely Benign. 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

Please provide a clinical indication or related ICD10 code on the requisition. Test will be delayed if the clinical indication is not received. Please direct any questions regarding this test to customer service at 800-345-4363.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
451953 IntelliGEN(R) Myeloid 451954 Specimen Type 31208-2
451953 IntelliGEN(R) Myeloid 451955 Clinical Indication 42349-1
451953 IntelliGEN(R) Myeloid 451956 Result Summary 69548-6
451953 IntelliGEN(R) Myeloid 451957 Interpretation 51968-6
451953 IntelliGEN(R) Myeloid 451958 Methodology and Limitations 49549-9
451953 IntelliGEN(R) Myeloid 451959 References 75608-0
451953 IntelliGEN(R) Myeloid 451961 Director Review 72486-4
451953 IntelliGEN(R) Myeloid 451962 PDF 51969-4

For Providers

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf