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NeoTYPE® CLL Profile
- Next Generation Sequencing (NGS)
This NeoTYPE® CLL Profile analyzes 12 genes through next-generation sequencing (NGS) and the CLL FISH Panel as noted below. Test orders include summary interpretation of all results together. FISH components of NeoTYPE Profiles may be ordered as Tech-Only by pathology clients who wish to perform the professional component. 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.
Turnaround time
14 Days
Level of Service
- Global
New York Approved: Yes
Specimen Requirements
Peripheral blood: 5 mL in EDTA tube. Bone marrow: 2 mL in EDTA tube. Fresh tissue: 0.5 - 1 cm3 in RPMI (Note: not acceptable for NYS samples). FFPE tissue: Paraffin block. Alternatively, send 1 H&E slide plus 10-14 unstained slides cut at 5 or more microns. Please use positively-charged slides and 10% NBF fixative is the recommended fixative. Do not use zinc or mercury fixatives (B5). Highly acidic or prolonged decalcification processes will not yield sufficient nucleic acid to accurately perform molecular studies. Note: not acceptable for IgVH Mutation Analysis if added on. Note: Please exclude biopsy needles, blades, and other foreign objects from transport tubes. These can compromise specimen viability and yield, and create hazards for employees. Note: Test in TNA-based. Please select Extract & Hold - TNA if specimen hold service is desired.
Storage and Transportation
Use cold pack for transport, making sure cold pack is not in direct contact with specimen. NYS clients please provide date and time of Collection. Please select Extract & Hold - TNA if specimen hold service is desired.
CPT Code(s)*
88374x4; 81450x1; 81263x1 (if IgVH Mutation Analysis is added)
*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.
Last Updated: January 22, 2025