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Test ID MCLNG MayoComplete Lung Cancer-Targeted Gene Panel with Rearrangement, Tumor


Ordering Guidance


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



Necessary Information


A pathology report (final or preliminary), at minimum containing the following information, must accompany specimen 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: tissue 360 mm(2)

-Minimum amount of tumor area: tissue 72 mm(2)

-These amounts are cumulative over up to 15 unstained slides and must have adequate percent tumor nuclei.

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

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

Slides: 1 Stained and 15 unstained

Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 15 unstained, nonbaked slides wit 5-micron thick sections of the tumor tissue.

Note: The total amount of required tumor nuclei can be obtained by scraping up to 15 slides from the same block.

Additional Information: Unused unstained slides will not be returned.

 

Specimen Type: Cytology slides (direct smears or ThinPrep)

Slides: 2 to 4 Slides

Collection Instructions: Submit 2 to 4 slides stained and coverslipped with a preferred total of 10,000 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.


Useful For

Diagnosis and management of patients with lung cancer

 

Assessing microsatellite instability

Genetics Test Information

This test uses targeted next-generation sequencing to determine microsatellite instability status and to evaluate for somatic mutations within the ALK, BRAF, EGFR, ERBB2, HRAS, KRAS, MDM2, MET, NRAS, RET, ROS1, and STK11 genes, and activating exon 14 skipping mutations in MET.

 

This test also uses multiplex reverse transcription polymerase chain reaction to detect gene fusions by identifying specific rearrangements (fusions) within the ALK, ROS1 and RET genes and expression imbalance for ALK, ROS1, RET, NTRK1, NTRK2, and NTRK3 genes. See Targeted Genes and Methodology Details for MayoComplete Lung Cancer Panel for details regarding the targeted gene regions evaluated by this test.

 

This test is performed to evaluate for somatic mutations within solid tumor samples. It does not assess for germline alterations within the genes listed.

Highlights

This test evaluates formalin-fixed paraffin-embedded tumor or cytology slides from patients with lung cancer for gene mutations and fusions to identify candidates for targeted therapy.

 

Microsatellite instability (MSI) status is determined (microsatellite stable, MSI-High) as part of this test and is often clinically actionable for determining the efficacy of immunotherapy in solid tumors.

Additional Tests

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

Testing Algorithm

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

Method Name

Sequence Capture and Targeted Next-Generation Sequencing (NGS)/Polymerase Chain Reaction (PCR)

Reporting Name

MayoComplete Lung Cancer Panel

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

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

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

12 to 20 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

88381-Microdissection, manual

81457

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MCLNG MayoComplete Lung Cancer Panel 101378-8

 

Result ID Test Result Name Result LOINC Value
617833 Result 82939-0
617834 Interpretation 69047-9
617835 Additional Information 48767-8
617836 Specimen 31208-2
617837 Tissue ID 80398-1
617838 Method 85069-3
617839 Disclaimer 62364-5
617840 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.