Hematologic Diseases

Detects mutations in key genes recurrently mutated in lymphoid malignancies. DNA sequence of targeted regions of the ABL1, ABL2, ALK, ARHGEF1, ARID1A, ARID2, ASXL1, ATM, B2M, BCL2, BCL6, BCOR, BIRC3, BRAF, BTK, CARD11, CCND1, CND2, CCND3, CD274, CD79A, CD79B, CDKN1B, CDKN2A, CDKN2B, CIITA, CREBBP, CRLF2, CSF1R, CTCF, CTNNB1, CXCR4, DDX3X, DIS3, DNMT3A, EBF1, EGR1, EP300, EPOR, ETV6, EZH2, FAM46C, FAS, FAT1, FBXW7, FGFR3, FOXO1, GATA3, GNA13, GNAI2, HIST1H1E, HRAS, ID3, IDH1, IDH2, IKBKB, IKZF1, IKZF3, IRAK4, ITPKB, JAK1, JAK2, JAK3, KLF2, KMT2D, KRAS, MALT1, MAP2K1, MAP3K14, MAPK1, MED12, MEF2B, MYC, MYCN, MYD88, NF1, NFKBIE, NOTCH1, NOTCH2, NOTCH3, NRAS, NT5C2, P2RY8, PDGFRB, PHF6, PIK3CA, PIK3CD, PIK3R1, PIM1, PLCG1, PLCG2, POT1, PPM1D, PRDM1, PRPS1, PTEN, PTPN11, RB1, REL, RHOA, RIPK1, RPS15, RUNX1, S1PR2, SAMHD1, SETD2, SF3B1, SGK1, SH2B3, SOCS1, SPEN, STAT3, STAT5B, STAT6, TBL1XR1, TCF3, TET2, TLR2, TNFAIP3, TNFRSF14, TP53, TRAF2, TRAF3, UBR5, WT1, XPO1, ZFHX4, and ZMYM3 genes is determined using next-generation sequencing (NGS) technology.

disease state indication(s)
Non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Richter's syndrome (RS), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), double-hit lymphoma (DHL), T-cell prolymphocytic leukemia (T-PLL), T-cell large granular lymphocytic leukemia (T-LGL), NK/T-cell lymphoma, hepatosplenic T-cell lymphoma (HSTCL), mycosis fungoides (MF), Sezary syndrome (SS), cutaneous T-cell lymphoma (CTCL), anaplastic T-cell lymphoma (ATCL), angioimmunoblastic T-cell lymphoma (AITL), peripheral T-cell lymphoma (PTCL), adult T-cell leukemia/lymphoma (ATLL), acute lymphoblastic leukemia (ALL)

clinical use
The Lymphoid Molecular Profile is intended as an aid in the diagnosis and subclassification of lymphoid neoplasms as well as to identify potential therapies based on the patient's unique molecular drivers. The profile includes analysis of genes known to be recurrently mutated in chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Richter's syndrome (RS), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), double-hit lymphoma (DHL), and various T-cell neoplasms.

methodology/product platform
Capture-based, next-generation sequencing (NGS)

specimen type and requirements
Peripheral blood: 2-3 mL in EDTA (purple-top) tube.
Bone marrow: 2-3 mL in EDTA (purple-top) tube.
Tissue: Preferred: Two (2) formalin-fixed, paraffin-embedded tissue/ fine needle aspirate (FFPE/FNA) blocks containing tumor tissue from recent surgery or biopsy or sixteen (16) 2x5 µm sections with accompanying H&E slide.
Acceptable Alternative: One (1) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) block containing tumor tissue from recent surgery or biopsy or eight (8) 2×5 µm sections with accompanying H&E slide.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
DO NOT FREEZE.

turnaround time
Global (TC & PC): 10-12 days

cpt code(s)
81455 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)