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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

 

This test is not intended for use for hematological malignancies.

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.

Highlights

This test 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


 



Necessary Information


Pathology report (final or preliminary) at minimum containing the following information must accompany specimen in order for testing to be performed:

1. Patient name

2. Block number-must be on all blocks, slides and paperwork (can be handwritten on the paperwork)

3. Tissue collection date

4. Source of the tissue



Specimen Required


This assay requires at least 20% tumor nuclei.

-Preferred amount of tumor area with sufficient percent tumor nuclei: tissue180 mm(2)

-Minimum amount of tumor area: tissue 36 mm(2)

-These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei.

-Tissue fixation: 10% neutral buffered formalin, not decalcified

-For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing in Special Instructions. In this document, the sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

Preferred:

Specimen Type: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue.

 

Acceptable:

Specimen Type: Tissue slide

Slides: 1 stained and 10 unstained

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

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block.

Specimen Type: Cytology slide (direct smears or ThinPrep)

Slides: 1 to 3 slides

Collection Instructions: Submit 1 to 3 slides stained and cover slipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells.

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times.

Additional Information: Cytology slides will not be returned.


Specimen Minimum Volume

See Specimen Required

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)

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