Hematologic Diseases

DNA sequencing of the amplified IGH gene variable (V) region is performed and is compared to the germline consensus sequence. The mutation status, V region family, and percent difference from germline are reported.

disease state indication(s)
Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL)

clinical use
Immunoglobulin heavy chain gene variable region (IgVH) somatic mutation status provides important prognostic information. For patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), unmutated IgVH is associated with an unfavorable prognosis, while hypermuated IgVH is associated with a favorable prognosis. Hypermutated IgVH is associated with indolent mantle cel lymphoma (MCL).

methodology/product platform
Sanger Sequencing

specimen type and requirements
Peripheral blood: 2-3 mL in EDTA (purple-top) tube.
Bone marrow: 2-3 mL in EDTA (purple-top) tube.
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): 8 days

cpt code(s)
81263 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)