Clonality Testing By Gene Rearrangement

PCR based clonality testing rests in the fundamentals of lymphocyte development.  The results of this assay are an integral adjunct to the thorough workup of lymphoproliferative disease.

This 54 year-old man presented with an annular erythematous eruption two-weeks after starting his blood pressure medication.

Lymphocytes in their development must rearrange antigen-receptor genes by recombining segments of their genome. This rearrangement is unique for each lymphocyte and results in enormous immunogenic diversity. Reactive lymphoproliferative conditions result in multiple different genotypic rearrangements and appear POLYCLONAL. In malignant processes, a single lymphocyte clone acquires growth advantage. This results in a single prominent genotypic rearrangement and appears CLONAL.

This 60 year-old man presented with persistent generalized annular erythematous macules for 5 years.

We are excited to offer the InVivoScribe Technologies’ Gene Rearrangement Assay. This represents a new approach to PCR-based clonality testing. These assays have notoriously lacked standardization between institutions with variable sensitivities and specificities. The current assay is standardized and carefully optimized by its manufacturer against positive and negative control samples using multiplex master mixes. Its development was followed by extensive validation testing of more than 400 clinical samples using the Revised European/ American Lymphoma (REAL) Classification.  Testing was done at forty-seven prominent independent testing centers throughout Europe in a collaborative study known as the BIOMED-2 Concerted Action (published in Leukemia. 2003 Dec; 17(12):2257-2317).  Using capillary electrophoresis and multiplex PCR master mixes, the intent of this assay is for the robust detection of clonal B- and T-cell populations in blood, bone marrow, snap-frozen tissue and formalin-fixed paraffin embedded tissue trimmed by laser capture microdissection. The results are a useful adjunct to current standard diagnostic procedures for hematopathologic malignancies.

Call us at (808) 691-4271 or email for details.

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We are certified by the American Board of Pathology, CLIA, JCAHO and CAP.