Alternative Name
CLL Prognostic Profile
Methodology
Molecular
Test Description

This test is performed by the sequencing the entire coding regions of the genes MYD88, NOTCH1, SF3B1, and TP53 plus IgVH Mutation Analysis and the CLL FISH Panel as noted. Test orders include summary interpretation of all results together. Individual genes from a validated list of genes can be added-on. 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.

Clinical Significance

Proper prediction of the course of CLL requires the analysis of multiple prognostic markers. The NeoTYPE CLL Prognostic Profile combines into one test the most significant markers available from FISH and molecular analysis, including the newest prognostic markers SF3B1and NOTCH1. SF3B1 mutations occur in 10-15% of CLL patients and serve as independent predictors of shortened time to treatment and poorer overall survival in CLL. NOTCH1 mutations occur in a similar proportion of CLL patients and are associated with poor prognosis, comparable to TP53 abnormalities. However, the most powerful biomarkers in this profile are IgVH mutation status and 17p deletion as determined by FISH.

Specimen Requirements
  • Peripheral blood: 5 mL in EDTA tube.
  • Bone marrow: 2 mL in EDTA tube.
  • Fresh tissue: 0.5 - 1 cm3 in RPMI.
Storage and Transportation

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.

CPT Code(s)*
81479x1, 88374x4
Turnaround Time

14 days

Level of Service
Global

*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.