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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, ALK, 2p23
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 ​
Tumor adequacy is optimally at least ​300 tumor cells for FISH testing, 50 cells is required.  Less than 50 cells will be cancelled. ​ ​ ​ ​ ​
Collection Processing Instructions
Provide a pathology report with each specimen. The laboratory will not reject specimens that arrive without this information but will hold the specimen until a pathology report is received.
 
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
< 50 tumor cells
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
Mayo Medical Laboratories Monday through Sunday   7 days ​FISH
Reference Lab
Mayo Clinic Laboratories
Reference Range Information
Interpretative Report
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, ALK, 2p23
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 ​
Tumor adequacy is optimally at least ​300 tumor cells for FISH testing, 50 cells is required.  Less than 50 cells will be cancelled. ​ ​ ​ ​ ​
Collection Processing
Provide a pathology report with each specimen. The laboratory will not reject specimens that arrive without this information but will hold the specimen until a pathology report is received.
 
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
< 50 tumor cells
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
Interpretative Report
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 Medical Laboratories Monday through Sunday   7 days ​FISH
Reference Lab
Mayo Clinic Laboratories
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.