CLL, trisomy 12, 11q- (11q deletion) or ATM, 13q- (13q deletion) or LAMP1, 17p- (17p deletion) or TP53, 6q- (6q deletion) or MYB, Nonleukemic form of chronic lymphocytic leukemia (CLL), SLL, Small lymphocytic leukemia (SLL), t(11;14)(q13;q32)-CCND1/IGH, t(14;19)(q32;q13)-IGH/BCL3
Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with small lymphocytic lymphoma (SLL) and other low-grade B-cell lymphomas
Distinguishing patients with 11;14 translocations who have mantle cell lymphoma from patients who have SLL
HIGHLIGHTS:This assay detects chromosome abnormalities observed in paraffin-embedded tissue samples from patients with small lymphocytic lymphoma.
This test does not include a pathology consult. If a pathology consult is requested, PATHC / Pathology Consultation should be ordered, and the appropriate fluorescence in situ hybridization (FISH) test will be ordered and performed at an additional charge.
Mayo Hematopathology Consultants are involved in both the pre-analytic (tissue adequacy and probe selection, when applicable) and post-analytic (interpretation of FISH results in context of specific case, when applicable) phases.
A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.
If the patient is being tracked for known abnormalities, indicate which probes should be used.
Panel includes testing for the following abnormalities using the probes listed:
When an IGH rearrangement is identified, reflex testing with the t(14;19)(q32;q13) IGH/BCL3 FISH probe will be performed.
Tissue Block Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.
Slide Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.
A reason for referral and pathology report are required in order for testing to be performed. Send information with specimen. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.
This test is not approved by the U.S. Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.
Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for FISH assays, however nonformalin-fixed samples will not be rejected.
Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.
A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.
A positive result is not diagnostic for small lymphocytic lymphoma, but may provide relevant prognostic information.
The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.