Neotype CLL Profile (plus IgVH Mutation Analysis)

Message
NGS (12 genes): ATM, BCL2, BIRC3, BTK, CARD11, CD79B, CXCR4, MYD88, NOTCH1, PLCG2, SF3B1, TP53
FISH probes: 6q- [SEC63 (6q21), MYB (6q23)] | ATM (11q22.3) | p53 (17p13.1) | Trisomy 12 (Cen 12) | 13q-/-13 (13q14, 13q34) | CCND1/IgH t(11;14)
Optional Add-on: IgVH Mutation Analysis


Test Code
LAB6501


Alias/See Also
CLL Profile


CPT Codes
88374x4; 81450x1; 81263x1 (if IgVH Mutation Analysis is added)

Preferred Specimen
Peripheral blood: 5 mL in EDTA tube.
Bone marrow: 2 mL in EDTA tube.
Fresh tissue: 0.5 - 1 cm3 in RPMI 


Instructions
Refrigerate specimen. Use cold pack for transport, making sure cold pack is not in direct contact with specimen. Ship same day as drawn whenever possible.


Methodology
Molecular

Report Available
14 days


Clinical Significance
The clinical course of chronic lymphocytic leukemia (CLL) is heterogenous, and it ranges from very indolent with a nearly normal life expectancy to rapidly progressive leading to early death. Genomic alterations in the TP53, BIRC3, NOTCH1, and SFB31 genes, unmutated IgVH and 17p deletion by FISH are associated with adverse outcomes, and their presence or absence can improve risk stratification and treatment selection beyond clinical staging and other prognostic biomarkers. However, the most powerful biomarkers in this profile are IgVH mutation status and 17p deletion as determined by FISH.


Performing Laboratory
Neogenomics Laboratories



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.