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Test ID: LUNGP Lung Cancer-Targeted Gene Panel, Tumor

Useful For

Identifying lung tumors that may respond to targeted therapies by assessing multiple gene targets within the EGFR, BRAF, KRAS, HRAS, NRAS, ALK, ERBB2, and MET genes simultaneously

 

Diagnosis and management of patients with lung cancer

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 Cancer Panel, 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


Preferred:

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 8 unstained slides (non-baked, 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
Varies Ambient (preferred)
  Frozen 
  Refrigerated 

Clinical Information

Targeted cancer therapies are defined as antibody or small molecule drugs that block the growth and spread of cancer by interfering with specific cell molecules involved in tumor growth and progression. Multiple targeted therapies have been approved by the FDA for treatment of specific cancers. Molecular genetic profiling is often needed to identify targets amenable to targeted therapies and to minimize treatment costs and therapy-associated risks.

 

Next-generation sequencing has recently emerged as an accurate, cost-effective method to identify alterations across numerous genes known to be associated with response or resistance to specific targeted therapies. This test uses formalin-fixed paraffin-embedded tissue or cytology slides to assess for common somatic mutations in 8 genes known to be associated with lung cancer. The results of this test can be useful for assessing prognosis and guiding treatment of individuals with lung tumors. These data can also be used to help determine clinical trial eligibility for patients with alterations in genes not amenable to current FDA-approved targeted therapies.

 

See Targeted Gene Regions Interrogated by Lung Panel in Special Instructions for details regarding the targeted gene regions evaluated by this test.

Reference Values

An interpretative report will be provided.

Interpretation

An interpretive report will be provided.

Clinical Reference

1. Beadling C, Neff TL, Heinrich MC, et al: Combining highly multiplexed PCR with semiconductor-based sequencing for rapid cancer genotyping. J Mol Diagn 2013;15:171-176

2. Sharma SV, Bell DW, Settleman J, Haber DA: Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer 2007;7(3):169-181

3. Mok TS: Personalized medicine in lung cancer: What we need to know. Nat Rev Clin Oncol 2011;8:661-668

4. Cheng L, Alexander RE, Maclennan GT, et al: Molecular pathology of lung cancer: key to personalized medicine. Mod Path 2012;25(3):346-369

5. Shigematsu H, Gazdar AF: Somatic mutations of epidermal growth factor receptor signaling pathway in lung cancers. 2006 Jan 15;118(2):257-262

6. Gao G, Ren S, Li A, et al: Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy is effective as first-line treatment of advanced non-small-cell lung cancer with mutated EGFR: a meta-analysis from 6 phase III randomized controlled trials. Int J Cancer 2012 Sep 1;131(5):E822-829

7. Eberhard DA, Johnson BE, Amler LC, et al: Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005;23(25):5900-5909

8. Frampton GM, Ali SM, Rosenzweig M, et al: Activation of MET via Diverse Exon 14 Splicing Alterations Occurs in Multiple Tumor Types and Confers Clinical Sensitivity to MET Inhibitors. Cancer Discov 2015 Aug 5(8):850-859

Day(s) and Time(s) Performed

Monday through Friday; Varies

Analytic Time

12 days

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

81445-Targeted genomic sequence analysis panel, solid organ neoplasm

Slide Review

88381-Microdissection, manual

LOINC Code Information

Test ID Test Order Name Order LOINC Value
LUNGP Lung Cancer Panel, Tumor In Process

 

Result ID Test Result Name Result LOINC Value
44150 Result Summary 50397-9
44151 Result 82939-0
44152 Interpretation 69047-9
44153 Additional Information 48767-8
44154 Specimen 31208-2
44155 Source 31208-2
46913 Tissue ID 80398-1
44156 Released By 18771-6

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
Mayo Clinic Laboratories | Oncology Catalog Additional Information:

mml-pulmonary-cancer