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Test ID LUNGR Lung Cancer Rearrangement Testing, Tumor

Useful For

Identifying lung tumors that may respond to targeted therapies by simultaneously assessing multiple genes involved in rearrangements resulting in fusion transcripts

 

Diagnosis and management of patients with lung cancer

Genetics Test Information

This test uses next-generation sequencing to identify rearrangements (fusions) involving ALK, ROS1, RET, and NTRK1. See Activated/Partner Gene Breakpoints Resulting in Targeted Fusion Transcripts Interrogated by Lung Panel in Special Instructions for details regarding the targeted gene regions evaluated by this test.

 

Of note, this test is performed to evaluate rearrangements (fusions) within solid tumor samples. This test is not intended for use for hematological malignancies.

Highlights

Evaluates formalin-fixed, paraffin-embedded tumor or cytology slides from patients with lung cancer for rearrangements (fusions) to identify candidates for targeted therapy.

 

Current data suggests that lung carcinomas with ALK rearrangements may be sensitive to ALK inhibitors.

Testing Algorithm

When this test is ordered, slide review will always be performed at an additional charge.

Method Name

Polymerase Chain Reaction (PCR)-Based Next Generation Sequencing

Reporting Name

Lung Rearrangement Testing, Tumor

Specimen Type

Varies


Advisory Information


At least 20% tumor is required for this assay. The amount of tissue needed is dependent on a variety of preanalytical factors (eg, cellularity, ischemic time, fixation). In general, the minimum specimen adequacy for this test is approximately a 6 mm(2) area of tissue (can be over multiple slides from 1 tissue block) or 5,000 total cells (5,000 total nucleated cells if using cytology slides).



Necessary Information


Pathology report must accompany specimen in order for testing to be performed.



Specimen Required


Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block

Acceptable

Slides: 1 Stained and 10 unstained slides

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained slides (nonbaked, charged slides preferred) with 5-micron thick sections of the tumor tissue.

 

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1-2 Slides

Collection Instructions: Submit 1-2 slides stained and coverslipped with at least 5,000 total nucleated cells

Additional Information: Cytology slides will not be returned.


Specimen Minimum Volume

Formalin-fixed, paraffin-embedded tissue block (preferred) or 1 slide stained with hematoxylin and eosin and 810 unstained slides (nonbaked, charged slides preferred) with 5- microns -thick sections of the tumor tissue with at least 6 mm(2) area of tissue (can be over multiple slides from one tissue block) and at least 20% tumor cells

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Reference Values

An interpretative report will be provided.

Day(s) and Time(s) Performed

Monday through Friday; Varies

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. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information

81405-RET

81479-(ROS1, ALK, NTKR1)

81479 (if appropriate for government payers)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LUNGR Lung Rearrangement Testing, Tumor In Process

 

Result ID Test Result Name Result LOINC Value
43702 Result Summary 50397-9
43703 Result 82939-0
44138 Interpretation 69047-9
44139 Additional Information 48767-8
44140 Specimen 31208-2
44141 Source 31208-2
46911 Tissue ID 80398-1
44142 Released By 18771-6

NY State Approved

Yes

Forms

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

Additional Tests

Test ID Reporting Name Available Separately Always Performed
SLIRV Slide Review in MG No, (Bill Only) Yes