Labcorp Pan-Heme NGS

This test is used to aid diagnosis, prognostic risk assessment and therapeutic selection in various myeloid and lymphoid malignancies.

Please provide a clinical indication or related ICD-10 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.

This test includes the following genes: ABL1, ANKRD26, ARID1A, ASXL1, ATM, ATRX, B2M, BCL2, BCL6, BCOR, BCORL1, BIRC3, BRAF, BRCC3, BTK, CALR, CARD11, CBL, CBLB, CBLC, CCND1, CCND3, CD274, CD79A, CD79B, CDK4, CDKN1B, CDKN2A, CDKN2B, CEBPA, CIITA, CREBBP, CRLF2, CSF1R, CSF3R, CSNK1A1, CTCF, CUX1, CXCR4, DDX41, DKC1, DNMT3A, EBF1, ELANE, EP300, ERG, ETNK1, ETV6, EZH2, FAS, FBXW7, FGFR1, FGFR3, FLT3, FOXO1, GATA1, GATA2, GNA13, GNAS, GNB1, HRAS, IDH1, IDH2, IKZF1, IKZF3, IL7R, IRF4, JAK1, JAK2, JAK3, KDM6A, KIT, KMT2A, KRAS, MALT1, MAP2K1, MAPK1, MED12, MEF2B, MPL, MYC, MYD88, NF1, NFE2, NOTCH1, NOTCH2, NPM1, NRAS, NSD2, NT5C2, P2RY8, PAX5, PDCD1, PDGFRA, PHF6, PIGA, PIK3CA, PIK3CD, PIK3CG, PIK3R1, PIM1, PLCG2, PML, POT1, PPM1D, PRDM1, PRPF8, PTEN, PTPN11, RAD21, RB1, RHOA, RIT1, RUNX1, SAMD9, SAMD9L, SBDS, SETBP1, SETD2, SF3B1, SH2B3, SMC1A, SMC3, SOCS1, SRSF2, STAG2, STAT3, STAT5B, STAT6, TCF3, TERC, TERT, TET2, TNFAIP3, TNFRSF14, TP53, U2AF1, WT1, UBA1, XPO1 and ZRSR2.

The sensitivity of this assay is 3% variant allele fraction (VAF) for single nucleotide variants (SNV), 5% for insertions/deletions (indels) less than 25 base pairs (bp) and 15% indels greater than or equal to 25 bp. CNV sensitivity is greater than or equal to two contiguous exons (subset) to whole gene is copy number less than or equal to 0.85 for deletions and greater than or equal to 1.15 for gains. 

Multiple clinically actionable hotspots have increased VAF sensitivity and include FLT3-ITDs down to 1% VAF, as well as Indel hotspots in CALR (chr19:13054563-13054625) and CEBPA (chr19:33,792,224-33,793,340) with VAF sensitivity greater than or equal to 5% for indels regardless of length. Insertions and deletions of any length are detected when at least one breakpoint is contained within a sequence read. Insertions up to 162 bp and deletions up to 95 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.

The Labcorp Pan-Heme NGS assay utilizes capture-based next-generation sequencing of whole genomic DNA libraries to identify gene alterations that have diagnostic, prognostic and therapeutic significance in hematologic malignancies. Somatic mutations in the genes analyzed include single nucleotide variants (SNVs), insertions and deletions (indels) in 141 genes and whole gene copy number variants (CNVs) in a subset of 16 genes and sub-gene (exon level) genes in a subset of five genes.

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