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Lung Cancer Panel by Next Generation Sequencing

Test Code

M LUNG NGS

Test Synonyms

EGFR, KRAS, BRAF, NRAS,

Associations

NSCLC adenocarcinoma; EGFR, KRAS, BRAF NRAS gene hotspot mutations

Reflex testing
FISH for ALK translocation (F ALK) can be performed as a reflex or in conjunction with this assay.
Methodology

Next Generation Sequencing Targeted HotSpots
QIAGEN® Human Tumor Actionable Mutations Panel (GeneRead™ DNAseq Targeted Panels V2) for targeted enrichment

Turnaround Time

7-10 days

Specimen Requirements

Formalin Fixed Paraffin Embedded tissue block or slides (3-5 slides at 5 micron minimum) NOTE: Include a surgical pathology report with the sample

Specimen Stability
Indefinite at ambient temperature (18-25°C)
Storage & Handling

Ship at ambient temperature, cool in summer. (Do not allow cool/refrigerated pack to directly contact sample)

Causes for Rejection

Insufficient DNA content ; Inadequate fixation; Improper labeling

Description

This sequencing panel is useful in determining eligibility for tyrosine kinase inhibitor (TKI) therapy in patients with non-small cell lung cancer (NSCLC). The EGFR mutation is present in 10-15% of lung adenocarcinomas, and predicts response to drugs such as erlotinib.  This test covers actionable regions of exons 18-21, including the T790M mutation which predicts resistance to TKI therapy. 

The KRAS mutation is present in 15-30% of lung adenocarcinomas, and is seen in both former/current smokers and non-smokers.  KRAS mutations are most often associated with tumors that are wild type for EGFR and ALK, and the mutation is most commonly seen in lung tumors with mucinous histology.  The role of KRAS in prediction of response to TKI therapy is unknown at this time.

BRAF mutations are found in 1-4% of all NSCLC, and mostly in adenocarcinomas.  The mutation is most prevalent in former/current smokers. While the V600E mutation is the predominant BRAF abnormality seen in melanoma, mutations within multiple other positions in the BRAF kinase domain have been identified in lung cancers.

NRAS mutations are present in ~1% of lung cancers.  While patient response to TKI therapy is unknown at this time, in vitro studies have shown response to TKI’s in cell lines harboring the NRAS mutation.

This panel utilizes next-generation sequencing (NGS) techniques.  Compared to multiple PCR and Sanger sequencing assays, this test can assess mutation status in multiple genes simultaneously, thereby reducing the risk of sample exhaustion in small biopsy specimens.  Furthermore, by performing this assay as a panel, it minimizes the turnaround time associated with multiple reflex-based methods.  An additional advantage of NGS technology is its ability to cover regions of genes not typically covered by common PCR techniques.  The resultant reports contain up-to-date and relevant clinical trial information regarding the detected abnormalities, which simplifies therapeutic decisions for physicians.

Trademarks

Qiagen and GeneRead are trademarks of Qiagen