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NeoTYPE® CLL Profile
- Next Generation Sequencing (NGS)
This panel is designed to detect key genetic abnormalities associated with chronic lymphocytic leukemia (CLL) through next-generation sequencing (NGS) and fluorescence in situ hybridization (FISH). It includes the following components:
DNA NGS (SNV/Indel):
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)
Test Customization: FISH components may be ordered separately as Tech-Only by pathology clients.
Optional Add-On: IgVH Mutation Analysis
Specimen Requirements
Bone Marrow Aspirate: 2 mL in EDTA tube.
Peripheral Blood: 5 mL in EDTA tube.
Fresh Lymph Node or Needle Core Tissue Biopsy: 0.5-1 cm3 in RPMI.
H&E slide (required) plus paraffin block.
Cut Slides: H&E slide (required) plus 10-14 unstained slides cut at 5+ microns.
Note on FFPE: Paraffin block is preferred. Do not use zinc fixatives. If submitting slides, please use positively-charged slides and 10% NBF fixative. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Do not use mercury fixatives (B5). Highly acidic or prolonged decalcification processes will not yield sufficient nucleic acid to accurately perform molecular studies.
Note: Test is 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. Ship same day as drawn whenever possible. NYS clients please provide date and time of Collection. Please select Extract & Hold - TNA if specimen hold service is
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: August 05, 2025