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Genetic Labs

Houston, Texas

Genetic Laboratory
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Medical Genetics Test Details

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IGVH Mutation Analysis
Test Information: Evaluation of IGVH mutation status in CLL.
Test Details
Test Code: 9060
Special Notes: The mutational status of the IgVH gene in patients with B-cell chronic lymphocytic leukemia (B-CLL) is reported to stratify patients into two subgroups with differing clinical outcomes; patients with unmutated IgVH (<2% mutated) have a poorer prognosis and shorter overall survival than those with mutated IgVH (>2% mutated).

Technical Limitations:

The sensitivity of the assay depends on multiple factors. In some patients, minor clonal populations and/or clones that are not amplified by the primer sets in use will not be detected and/or sequenced. The assay cannot reliably detect <5 positive cells per 100 normal cells.

Results of this test must always be interpreted in the context of relevant clinical and pathological data, and should not be used alone for a diagnosis of malignancy. This test is not intended to detect minimal residual disease.

Useful Publications:
- Unmutated Ig VH Genes Are Associated With a More Aggressive Form of Chronic Lymphocytic Leukemia
- Biologic and Clinical Significance of Molecular Profiling in Chronic Lymphocytic Leukemia
Technical Information
Methodology: RT-PCR followed by sequencing. The percentage of mutation is determined by comparing the patient sequence of the IgVH region to a germline gene sequence database (http://vbase.mrc-cpe.cam.ac.uk/), IgBlast (http://www.ncbi.nlm.nih.gov/igblast/) and IMGT(http://imgt.cines.fr/cgibin/IMGTlect.jv?livret=0).
Gene Name: IGVH
Sample & Shipping Information
Test Requisition: Tumor Analysis
Specimen Type: Bone Marrow
Requirements: 2-5 mL Bone Marrow (Min: 1 mL) in a EDTA (purple-top) tube(s).

Transport Temperature: Ship at ambient temperature (18-25C/64-77F).

Unacceptable Conditions: Frozen specimens.

Stability: Ambient: 24 hours; Frozen: Unacceptable

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. Do not heat or freeze.



Specimen Type: Leukemic Blood
Requirements: 5-10 mL Leukemic Blood (Min: 1 mL) in a EDTA (purple-top) tube(s).

Transport Temperature: Ship at ambient temperature (18-25C/64-77F).

Unacceptable Conditions: Frozen specimens.

Stability: Ambient: 24 hours; Frozen: Unacceptable

Shipping Conditions: Ship at ambient temperature (18-25C/64-77F) in an insulated container by overnight courier. Specimen should arrive in the laboratory within 24 hrs of collection. Do not heat or freeze.



Turn Around Time: 10 - 14 days
Billing Information
List Price: *For Insurance or Institutional Prices, please call.
CPT Codes: 81263x1


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