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Beaumont Laboratory

Chronic Lymphocytic Leukemia (CLL) Gene Expression and IgVH Mutational Status

CLL Gene Expression and IgVH Mutational Status, EPIC: LAB6380, SOFT: GCLLG


Sample should be drawn as early in the day as possible so the specimen can be delivered to the Laboratory the same day.

Specimen Collection Criteria

Collect: Blood OR Bone Marrow.

  • Blood: 10 mL whole blood in Lavender-top EDTA tubes or Yellow-top ACD tubes. (Min: 5.0 mL)
  • Bone Marrow: 1.0 mL bone marrow aspirate in a Lavender-top EDTA tube. (Min: 0.5 mL)

FedEx Shipping Instructions

Transport 10 mL whole blood (minimum: 5 mL) or 1.0 mL bone marrow aspirate (minimum: 0.5 mL), refrigerated. Do not freeze specimens. Specimens must be received within 48 hours of collection.

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Physician Office/Drawsite Specimen Preparation

Do not freeze specimens. Maintain specimens at room temperature (20-26°C or 68-78.8°F) and transport to the Laboratory within 4-6 hours of collection.

Preparation for Courier Transport

Transport: Whole blood or bone marrow at room temperature (20-26°C or 68-78.8°F).

Rejection Criteria

  • Frozen specimens. 
  • Unlabeled tubes. 
  • Specimens collected in heparin (Green-top), clot tubes (Red-top), or SST tubes. 


Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 6 hours
Refrigerated (2-8°C or 36-46°F): 48 hours
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days


Royal Oak Clinical Molecular Pathology Laboratory.


Once per week.
Results available within 21 days.

Reference Range


Test Methodology

DNA and RNA extraction and analysis for immunoglobulin heavy chain variable region (IgVH) mutational status and reverse transcription-PCR for analysis of gene expression for LPL and ADAM29 with reporting of expression ratio.


  • Quantification of LPL and ADAM29 gene expression is a strong prognostic indicator in CLL, with LPL/ADAM29 ratio of greater than 1 correlating with unmutated VH status and poor prognosis.
  • The mutational status of the immunoglobulin heavy chain variable genes is considered the best prognostic marker in CLL. Cases with mutated IgVH usually demonstrate a favorable evolution compared to unmutated cases (greater than 98% homology), which are characterized by progressive disease and continuing treatment needs.

Clinical Utility

  • IgVH mutational status and the gene expression analysis are used as prognostic indicators in CLL.
  • The test is recommended for risk stratification of CLL patients.

CPT Code

81479, 81261, 81263.

Test Codes


Last Updated


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This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.