• Test Code:
  • Department:
  • Test Synonyms:
  • CPT Code(s):
    88271x688275x688368x1 (FFPE)88369x5 (FFPE)

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) is a clonal B cell disorder, and represents the most common leukemia in Western countries.  Conventional chromosome studies are often unsuccessful due to the low mitotic activity of the abnormal cells; therefore, FISH is an important adjunct to metaphase chromosome analysis in CLL.  This FISH panel is designed to detect the most common, and/or prognostically-significant abnormalities in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL); a majority of cases have abnormalities that may be detected by FISH (Swerdlow et al. 2008).  Additionally, this panel may be useful in discriminating CLL from leukemic-phase mantle cell lymphoma.  FISH studies are useful adjuncts to complete chromosome studies, particularly when following an abnormal clone, assessing relapse and progression, or when material is inadequate for chromosomal analysis.

The CLL/SLL FISH panel includes:

  1. IGH/CCND1 dual-fusion probe, to detect t(11;14).
  2. ATM locus-specific probe, to detect deletion of ATM (11q22.3).
  3. TP53 locus-specific probe, to detect deletion of TP53 (17p13.1).
  4. D13S319/13q34 locus-specific probes, deletion of chromosome 13q or monosomy 13.
  5. CEP 12 enumeration probe, to detect trisomy 12.
  6. 6q21,6q23 (MYB) locus-specific probes, to detect deletions involving chromosome 6q.

Note: Reflex testing may include IGH break-apart or BCL3 break-apart when relevant. Additional charges apply. Interphase FISH analysis is not intended to stand alone, but rather to provide supplemental information to routine cytogenetic studies.


Slides are prepared per standard protocols and 100-200 interphase cells are scored per probe.

*Please note: It is our laboratory policy to analyze at least one metaphase cell from every hybridization if possible, including both normal and abnormal cells if both exist.

Specimen Requirements:

  • FFPE Slides

    • If sending slides, please include H&E stained slide cut from same block
    • Preferred slice thickness is 4-5 microns on positively charged slides. 
    • Please submit 6-12 slides.  Store at room temperature.
    • Contact Client Services at (855) 535-1522 for shipping supplies and instructions
  • Bone Marrow:  Shortly before aspiration add 0.2 cc of Sodium Heparin (1,000 units/ml) to tube of transport medium (please contact lab to arrange for transport medium to be sent).  Add at least 1 cc of bone marrow aspirate to the tube and suspend well.  Allow no clots to form.

  • Bone Marrow Smears:  Provide 10 slides

  • Blood: May be used if bone marrow is inaspirable and blasts (.5%) are present.  Send in Sodium Heparin tube.
    • Adult - 3-5 mL drawn into a GREEN top sodium heparin vacutainer tube or into a pre-heparinized plastic syringe (use 0.2 cc sodium heparin, 1000 unit/mL).  Do NOT use lithium heparin.
    • Child - 1-2 mL, as above.
    • Infant - 1-2 mL, as above. 
    • Keep at room temperature and transport to laboratory as soon as possible.
    • Contact Client Services at (855) 535-1522 for supplies and instructions.
  • Bone core biopsy: May also provide cells in cases where marrow is severely packed.  Send in transport medium with Sodium Heparin.
  • Peripheral Blood or Bone marrow smears:  Provide 10 slides
  • Paraffin embedded tumor block or 10 slides (4-5 micron tissue) on positively charged slides.
  • Lymph node or tumor: Tumor specimens of at least 0.5 cm3 (up to 3 inches in diameter) are immediately collected with sterile methods into closable containers with sterile transport medium.* Needle biopsies will be accepted, but are often difficult to grow.  Deliver the specimen in transport medium to the laboratory within a day, if possible, with decreased success rates as specimens are delayed in transit.  Protect sample from temperature extremes during shipping.
*Sterile Ringer’s solution, either lactated or non-lactated and sterile isotonic saline are alternatives, if no complete RPMI is available.  Contact Client Services for more information on media requirements.

It is preferable to collect the specimen before initiation of chemotherapy in the patient.  Tumor samples should be selected from viable areas, with as little normal or necrotic material as possible. 

Unacceptable specimens are acellular, necrotic specimens, septic specimens, specimens in fixative or frozen, or specimens collected more than one week previously.

A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES.  Please include detailed clinical information. 

Test Performed (Days):

Mon - Sat

Turn Around Time:

5 – 10 days Contact Lab at 855-KDL-1LAB (535-1522) - Time varies depending on number of tests performed.

Shipment Sensitivity Requirements:

  • Keep specimen at room temperature during transit. 
  • Do not use the cold pack provided in the KDL shipping kit. 
  • Ship the specimen overnight express, using the FedEx priority overnight label provided. 
  • The specimen must arrive at the lab no more than 24 hours after collection.


  1. Immunoglobulin gene translocations in chronic lymphocytic leukemia: A report of 35 patients and review of the literature
  2. Swerdlow et al. (Eds.): WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC: Lyon 2008

Additional Info:

The Knight Cancer Institute at Oregon Health & Science University is a pioneer in the field of precision cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down just the cells that enable cancer to grow. This breakthrough has made once-fatal forms of the disease manageable and transformed how cancer is treated. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle – an honor earned only by the nation's top cancer centers. It is headquarters for one of the National Cancer Institute's largest research collaboratives, SWOG, in addition to offering the latest treatments and technologies as well as hundreds of research studies and clinical trials.

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