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24914 ALK (2p23) Rearrangement, FISH, Tissue (LCAF)

ALK (2p23) Rearrangement, FISH, Tissue (LCAF)
Test Code: ALKRESO
Synonyms/Keywords
​Lung carcinoma, Non-small cell lung cancer (NSCLC)
Useful For

​Identifying patients with late-stage, non-small cell lung cancers who may benefit from treatment with the drug Xalkori.

This test is always reflexed when EGFR is initially ordered.

Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Tissue
FFPE
tumor tissue block
Slides 4 consecutive, unstained, 5 micron thick sections placed on positively charged slides and 1 H&E slide 3 consecutive, unstained, 5 micron thick sections placed on positively charged slides and 1 H&E slide
Collection Processing Instructions

1. A pathology report is required in order for testing to be performed. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

2. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

 
For blocks residing at a Non-Clinic location, please complete the Surgical Pathology Specimen Request form found in FORMS PRINTER or found here:
 
Surgical Pathology Specimen Request 
Specimen Stability Information
Specimen Type Temperature
Tissue ​ Ambient (preferred)
​Refrigerated
Rejection Criteria
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability. 
Interference

This test is intended to be used for therapeutic purposes in pulmonary carcinoma. This FISH assay does not rule out other chromosome abnormalities.

While results may indicate the likely response to ALK inhibitor therapy, selection of treatment remains a clinical decision.

Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation

Mayo Clinic Laboratories

Monday through Sunday   7 days Fluorescence In Situ Hybridization (​FISH)
Reference Lab
Reference Range Information
An interpretative report will be provided. 
Interpretation
​A positive result (ALK rearrangement identified) is detected when the percent of cells with an abnormality exceeds the normal cutoff for the ALK probe set. A positive result suggests rearrangement of the ALK locus and a tumor that may be responsive to ALK inhibitor therapy. A negative result suggests no rearrangement of the ALK gene region at 2p23.
 
A specimen is considered positive if >50% demonstrate a signal pattern consistent with an ALK rearrangement and considered negative if <10% of cells are positive. If the results are equivocal (>10% and <50%), an additional 50 cells are scored and would be considered positive if >15% of cells exhibit a signal pattern consistent with an ALK rearrangement and negative if <15% of cells exhibit an ALK rearrangement.
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
88291 1 Interpretation and report​
88271​ ​2 ​Probe Set, 1ST ​​
88271 2 Probe, +2 ​as needed
88271 1​ Probe, +1 ​​as needed
88271​ ​2 ​Probe, +2 ​​as needed
88271​ ​3 ​Probe, +3 ​​as needed
​88274 ​1 Interphases, <25​ ​​as needed
​88274 ​1 ​Interphases, 25-99 ​​as needed
​88275 ​1 ​Interphases, >100 ​​as needed
Synonyms/Keywords
​Lung carcinoma, Non-small cell lung cancer (NSCLC)
Ordering Applications
Ordering Application Description
​Centricity ​ALK Rearrangement by FISH
​Cerner ​None
​​COM ​ALK (2p23) Rearrangement, FISH
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
Tissue
FFPE
tumor tissue block
Slides 4 consecutive, unstained, 5 micron thick sections placed on positively charged slides and 1 H&E slide 3 consecutive, unstained, 5 micron thick sections placed on positively charged slides and 1 H&E slide
Collection Processing

1. A pathology report is required in order for testing to be performed. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

2. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

 
For blocks residing at a Non-Clinic location, please complete the Surgical Pathology Specimen Request form found in FORMS PRINTER or found here:
 
Surgical Pathology Specimen Request 
Specimen Stability Information
Specimen Type Temperature
Tissue ​ Ambient (preferred)
​Refrigerated
Rejection Criteria
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability. 
Interference

This test is intended to be used for therapeutic purposes in pulmonary carcinoma. This FISH assay does not rule out other chromosome abnormalities.

While results may indicate the likely response to ALK inhibitor therapy, selection of treatment remains a clinical decision.

Useful For

​Identifying patients with late-stage, non-small cell lung cancers who may benefit from treatment with the drug Xalkori.

This test is always reflexed when EGFR is initially ordered.

Reference Range Information
An interpretative report will be provided. 
Interpretation
​A positive result (ALK rearrangement identified) is detected when the percent of cells with an abnormality exceeds the normal cutoff for the ALK probe set. A positive result suggests rearrangement of the ALK locus and a tumor that may be responsive to ALK inhibitor therapy. A negative result suggests no rearrangement of the ALK gene region at 2p23.
 
A specimen is considered positive if >50% demonstrate a signal pattern consistent with an ALK rearrangement and considered negative if <10% of cells are positive. If the results are equivocal (>10% and <50%), an additional 50 cells are scored and would be considered positive if >15% of cells exhibit a signal pattern consistent with an ALK rearrangement and negative if <15% of cells exhibit an ALK rearrangement.
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation

Mayo Clinic Laboratories

Monday through Sunday   7 days Fluorescence In Situ Hybridization (​FISH)
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)
Quantity Description Comments
88291 1 Interpretation and report​
88271​ ​2 ​Probe Set, 1ST ​​
88271 2 Probe, +2 ​as needed
88271 1​ Probe, +1 ​​as needed
88271​ ​2 ​Probe, +2 ​​as needed
88271​ ​3 ​Probe, +3 ​​as needed
​88274 ​1 Interphases, <25​ ​​as needed
​88274 ​1 ​Interphases, 25-99 ​​as needed
​88275 ​1 ​Interphases, >100 ​​as needed
For most current information refer to the Marshfield Laboratory online reference manual.