Detects clonal B-cell immunoglobulin heavy chain (IGH) gene rearrangement by polymerase chain reaction (PCR) of variable and joining regions on chromosome 14.

disease state indication(s)
B-cell neoplasms

clinical use
B-cell immunoglobulin heavy chain (IGH) gene rearrangement analysis is useful for determining clonality in the diagnostic evaluation of B-cell neoplasms.

methodology/product platform
Polymerase chain reaction (PCR)

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): 7 days

cpt code(s)
81261 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)