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Test Code ROS1F Lung Cancer, ROS1 (6q22) Rearrangement, FISH, Tissue

Useful For

Identifying ROS1 gene rearrangements irrespective of the ROS1 fusion partner gene

 

Aiding in the diagnosis of many neoplasms, including but not limited to, inflammatory myofibroblastic tumor and certain cutaneous melanocytic tumors, associated with a ROS1 rearrangement at 6q22.1 when used conjunction with an anatomic pathology assessment

 

Identifying patients with a ROS1 rearrangement who may benefit from treatment with directed tyrosine kinase inhibitors

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
_I099 Interphases, 25-99 No, (Bill Only) No
_I300 Interphases, >=100 No, (Bill Only) No
_IL25 Interphases, <25 No, (Bill Only) No
_PADD Probe, +1 No, (Bill Only) No
_PB02 Probe, +2 No, (Bill Only) No
_PB03 Probe, +3 No, (Bill Only) No
_PBCT Probe, +2 No, (Bill Only) No

Testing Algorithm

This test includes a charge for probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization probes). Analysis charges are based on the number of cells analyzed per probe. No analysis charges apply if there are insufficient representative cells for evaluation.

 

Appropriate ancillary probes may be performed at the consultant's discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

ROS1 (6q22), FISH, Ts

Specimen Type

Tissue


Ordering Guidance


This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation, and appropriate testing will be added at the discretion of the pathologist and performed at an additional charge.

 

Multiple oncology (cancer) gene panels are also available. For more information see Hematology, Oncology, and Hereditary Test Selection Guide



Additional Testing Requirements


Confirmation testing for the presence of a possible ROS1 fusion transcript by next-generation sequencing to resolve atypical or unbalanced fluorescence in situ hybridization results is available. Dependent on the results of prior testing and available specimen, one or more of the following tests may be considered: MCLNG / MayoComplete Lung Cancer-Targeted Gene Panel with Rearrangement, Tumor; MCRSP / MayoComplete Targeted RNA Sequencing Panel, Next-Generation Sequencing, Tumor; or MCSTP / MayoComplete Solid Tumor Panel, Next-Generation Sequencing, Tumor.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.

2. The following information must be included in the report provided:

-Patient name

-Block number - must be on all blocks, slides, and paperwork

-Collection date

-Tissue source

3. 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.



Specimen Required


Submit only 1 of the following specimens:

 

Preferred:

Specimen Type: Tissue block (fresh tissue is not acceptable)

Collection Instructions:

1. Submit a formalin-fixed, paraffin-embedded tumor tissue block.

2. Blocks prepared with alternative fixation methods (eg, Prefer, Bouin's) will be attempted but are less favorable for successful results. Provide fixation method used.

Additional Information:

1. Paraffin-embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).

2. Decalcified paraffin-embedded specimens will have testing attempted; however, the success rate is approximately 50%. Testing may be canceled if sufficient tumor tissue is not present.

3. Submitted fresh tissue specimens will be canceled upon receipt. If only fresh tissue is available, embed in paraffin prior to sending.

 

Acceptable:

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin-stained and 4 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 4 consecutive unstained, positively charged, unbaked slides with 5-micron thick sections of the tumor tissue.

Additional Information: Broken or cracked unstained slides will be rejected. Stained slides that were broken and repaired (ie, double mounted) at the client site will not be rejected, as, in most cases, they can still be reviewed under the microscope. However, due to the double mounting, digital scanning cannot be performed.


Specimen Minimum Volume

Slides: 1 Hematoxylin and eosin-stained and 2 unstained

Specimen Stability Information

Specimen Type Temperature Time
Tissue Ambient (preferred)
  Refrigerated 

Reject Due To

Broken or cracked unstained slides Reject
Broken or cracked stained slides that cannot be repaired Reject

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

88271x2, 88291-DNA probe, each (first probe set), Interpretation and report

88271x2-DNA probe, each; each additional probe set (if appropriate)

88271x1-DNA probe, each; coverage for sets containing 3 probes (if appropriate)

88271x2-DNA probe, each; coverage for sets containing 4 probes (if appropriate)

88271x3-DNA probe, each; coverage for sets containing 5 probes (if appropriate)

88274 w/modifier 52-Interphase in situ hybridization, <25 cells, each probe set (if appropriate)

88274-Interphase in situ hybridization, 25 to 99 cells, each probe set (if appropriate)        

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ROS1F ROS1 (6q22), FISH, Ts 81747-8

 

Result ID Test Result Name Result LOINC Value
52235 Result Summary 50397-9
52237 Interpretation 69965-2
54595 Result 62356-1
CG755 Reason for Referral 42349-1
52238 Specimen 31208-2
52239 Source 31208-2
52240 Tissue ID 80398-1
52241 Method 85069-3
55035 Additional Information 48767-8
53821 Disclaimer 62364-5
52242 Released By 18771-6

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.