* If IGH in MM panel is abnormal

 

Chronic Myeloid Leukemia (BCR/ABL, 9;22, or Philadelphia Chromosome)
Test Code 10002
CPT Code 88368 x 2

Cytogenetically, the (9;22) translocation is the hallmark of CML seen in 95+% of patients. A reciprocal translocation between chromosomes 9q34 and 22q11 result in the formation of the Philadelphia (Ph) Chromosome. The presence of the Ph chromosome is also seen in 5% of children and ~20% of adults with acute lymphoblastic leukemia (ALL).

Myelodysplastic Syndrome (MDS)
Test Code 10003
CPT Code 88368 x 6

A neoplastic bone marrow disease with marked similarities to the acute myeloid leukemia's caused by both qualitative and quantitative defects. MDS consists of a group of relatively ill-defined disorders affecting mostly elderly persons. These disorders share many features with the nonlymphatic leukemia's. Although there have been up to 17 structural rearrangements and 10 numerical changes associated with MDS, the four most common chromosome abnormalities are found in this FISH panel.

Multiple Myeloma (MM)
Test Code 10010
CPT Code 88368 x 10

The associated translocations with the immunoglobulin heavy chain gene are very common in Multiple Myeloma. There are four frequently observed chromosomal aberrations associated with IgH translocations which include 11q13, 6p21, 4p16 and 16q23 regions. The (4;14) translocation accounts for about 15% of Multiple Myeloma tumors.

 

Chronic Lymphocytic Leukemia (CLL)
Test Code 10004
CPT Code 88368 x 7

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia in the Western world. The disease is characterized by the accumulation of mature-appearing lymphocytes in the blood, bone marrow, lymph nodes, and spleen. CLL has a highly variable clinical course and some patients die from the disease within a few months from diagnosis, whereas others live for 20 years or more. FISH testing serves as both a diagnostic tool as well as a screen to help prognostically stratify the risk of CLL patients. Peripheral blood or bone marrow specimens are analyzed by FISH using FISH probes specific for ATM (11q22.3-q23.1), chromosome 12 centromere, RB-1 (13q14), D13S25 (13q14.3), and p53 (17p13.1) loci.

Acute Myeloid Leukemia (AML)
Test Code 10005
CPT Code 88368 x 11
 

The (8;21) translocation is associated with AML, specifically in AML-M2 subtype. The translocation breakpoints are clustered within a limited region of the AML1 and ETO genes and can be easily identified by FISH.

Acute Promyelocytic Leukemia (APL)
Test Code 10006
CPT Code 88368 x 2

Acute promyelocytic leukemia is characterized by a (15:17) chromosomal translocation involving the retinoic acid receptor-alpha gene on chromosome 17. In 95% of cases of APL, retinoic acid receptor-alpha (RARα) gene on chromosome 17 to the promyelocytic leukemia gene (PML) on chromosome 15. Four other gene rearrangements have been described in APL fusing RAR to promyelocytic leukemia zinc finger (PLZF), nucleophosmin (NPM), nuclear matrix associated (NuMA), or signal transducer and activator of transcription (STAT) 5b genes..

Mantle Cell Lymphoma (MCL)
Test Code 10007
CPT Code 88368 x 2

The t(11;14) translocation has been identified as a consistent cytogenetic abnormality in Mantle Cell Lymphoma. This translocation occurs from breakpoints within the JH region of the IgH gene at 14q32 and the breakpoints of the BCL1/CCND1 gene at the 11q13 region.

Burkitt Lymphoma (BL)
Test Code 10008
CPT Code 88368 x 3

The (8;14) translocation is the hallmark of Burkitt’s Lymphoma as seen in virtually 100% of cases. It is also seen in about 15% of high grade B-cell lymphoma cases.

Follicullar Lymphoma (FL)
Test Code 10009
CPT Code 88368 x 2

The (14;18) translocation characterizes approximately 60% of B-cell non-Hodgkin’s lymphoma. It is present in 85% of the indolent follicular lymphomas and 25% of diffuse aggressive large B-cell lymphomas (DLBCL). This translocation is used as a diagnostic and prognostic marker.

 

Specimen Requirements for Leukemia and Lymphoma Disorders:
1. Bone Marrow Aspirate:
* Sodium Heparin (green top tube)
* 1.0 mL
* Refrigerate specimen. DO NOT FREEZE. Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.
•
2. Peripheral Blood:
* Sodium Heparin (green top tube)
* 1.0 mL
* Refrigerate specimen. DO NOT FREEZE. Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.

 

Leukemia Turnaround Time: 48-72 hours

FISH Analysis, Bladder Cancer
Test Code 10011
CPT Code 88367 x 4

The FISH Analysis Kit consists of a four-color, four-probe mixture of DNA probe sequences homologous to specific regions on chromosomes 3, 7, 9, and 17. The probe mixture consists of cen 3 SpectrumRed, cen 7 SpectrumGreen, cen 17 SpectrumAqua and Locus Specific Identifier (LSI 9p21 SpectrumGold. The FISH Analysis, Bladder Cancer Kit is designed for the detection and quantification of chromosomes 3, 7, and 17, and the 9p21 locus in human urine specimens by FISH, and is used in conjunction with cystoscopy.

Specimen Requirements-FISH Analysis, Bladder Cancer:

1. Voided Urine
*Preservative Pill - Sterile
*50 mls
*Refrigerate specimen. DO NOT FREEZE. Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.

PathVysion^®.
Test Code 10013
CPT Code 88368 x 2

The PathVysion^®. HER-2 DNA Probe Kit (PathVysion^®. Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. The PathVysion^®. Kit is indicated as an aid in the assessment of patients for whom HERCEPTIN^®. (Trastuzumab) treatment is being considered.

PathVysion^®. Specimen Requirements:
1. Paraffin Block
*Sliced 4-5 microns
*1 H&E slide

PathVysion^®. Turnaround Time:

48-72 hours