IntelliGEN® Myeloid

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)

Lavender-top (EDTA) tube, green-top (sodium heparin) tube, tan-top (K2-EDTA) tube or pink-top (K2-EDTA) tube

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, and 3) therapeutic options.

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. 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 Food and Drug Administration.

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