Test Catalog

Test Name

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

Useful For Suggests clinical disorders or settings where the test may be helpful

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

Genetics Test Information Provides information that may help with selection of the correct genetic test or proper submission of the test request

This test uses targeted next-generation sequencing to evaluate for somatic mutations within the EGFR, BRAF, KRAS, HRAS, NRAS, ALK, ERBB2, and MET genes. See Targeted Gene Regions 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 for somatic mutations within solid tumor samples. This test is not intended for use for hematological malignancies. Additionally, this test does not assess for germline alterations within the genes listed.

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretative report will be provided.

Interpretation Provides information to assist in interpretation of the test results

An interpretive report will be provided.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test cannot differentiate between somatic and germline alterations. Additional testing may be necessary to clarify the significance of results if there is a potential hereditary risk.

 

This test is not intended for use for hematological malignancies.

 

DNA variants of uncertain significance may be identified.

 

A negative (wild-type) result does not rule out the presence of a mutation that may be present but below the limits of detection of this assay.

 

Point mutations and small insertion/deletion mutations will be detected in the EGFR, BRAF, KRAS, HRAS, NRAS, ERBB2, ALK, and MET genes only. This test does not detect large single or multiexon deletions or duplications or genomic copy number variants in any of the genes tested.

 

Rare polymorphisms may be present that could lead to false-negative or false-positive results. Test results should be interpreted in the context of clinical findings, tumor sampling and other laboratory data. If results obtained do not match other clinical or laboratory findings, please contact the laboratory for updated interpretation. Misinterpretation of results may occur if the information provided is inaccurate or incomplete.

 

Reliable results are dependent on adequate specimen collection and processing. This test has been validated on cytology slides and formalin-fixed, paraffin-embedded tissues; other types of fixatives are discouraged. Improper treatment of tissues, such as decalcification, may cause PCR failure.

Supportive Data

We have developed a next-generation sequencing assay to detect somatic mutations that can be used to assist in predicting prognosis and identifying targeted therapies for the management of patients with lung cancer. This assay has been shown to be very reproducible, having a 100% concordance for intra- and interassay reproducibility experiments.

 

We observed 96.2% concordance, detecting 75 of 78 somatic mutations that had previously been detected by various other molecular methods. These mutations included 61 SNPs and 17 Indels across ALK (n=3), BRAF (n=15), EGFR (n=17), ERBB2 (n=7), HRAS (n=2), KRAS (n=17), MET (n=5), and NRAS (n=12) genes in 70 known unique samples. No pathogenic variants were detected in the 29 unique, known mutation negative samples.

Clinical Reference Recommendations for in-depth reading of a clinical nature

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

Special Instructions Library of PDFs including pertinent information and forms related to the test