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Lung cancer focused gene panel

Also known as: Lung panel, ROS1, NSCLC

Test category:

Oncology - Lung cancer

Use of test

Purpose:

Mutations in the EGFR (epidermal growth factor receptor) gene can guide the choice of therapy in patients with non-small cell lung cancer (NSCLC). Clinically relevant mutations occur in exons 18, 19, 20 and 21 of the gene. Gene fusions leading to overexpression of the ALK or ROS1 genes also have implications regarding choice of therapy.

Mutations in the KRAS gene are mutually exclusive with other oncogenic drivers. Mutations in BRAF, ERBB2 (HER2) and MET are associated with emerging therapies.

Utility:

The presence of specific EGFR mutations in non-small cell lung cancer (NSCLC) indicates sensitivity or resistance to EGFR tyrosine kinase inhibitor therapies. The presence of an ALK or ROS1 rearrangement in NSCLC detected by fluorescent in situ hybridisation (FISH) analysis is associated with increased sensitivity to tyrosine kinase inhibitor therapy.

There is emerging evidence regarding utility of BRAF tyrosine kinase inhibitors in BRAF-mutated NSCLC, and HER2 inhibitors in ERBB2-mutated NSCLC, and tyrosine kinase inhibitors in MET-mutated NSCLC.

This test can be expanded to a full Find It panel.

Ethical considerations:

This is an assay for non-heritable mutations. It does not raise issues of ethics or consent that are different from most other investigations ordered in the routine care of a patient.

Methodology:

IHC using an assay designed to detect ALK or ROS1 overexpression in NSCLC samples. If IHC is equivocal or positive, this is followed by FISH analysis, using probes to identify rearrangements resulting in the fusion of ALK or ROS1 with a partner gene.

Targeted analysis of clinically relevant activating and resistance mutations in exons 18, 19, 20 and 21 of the EGFR gene. Targeted analysis of clinically relevant activating mutations in the KRAS gene (codons 12, 13, 59, 61, 117, 146), BRAF gene (codon 600) ERBB2 gene (exon 20 insertions), and MET gene (exon 14 skipping mutations). For further details, please refer to the description of the full Find It panel.

Requesting the test

Ordering:

This test is usually requested by a surgeon, oncologist or the pathologist providing the initial histopathology report. Please use the specific request form (see link below).

Request form:

Download the solid tumour somatic mutation request form.

Sample required:

Formalin-fixed, paraffin embedded tissue (FFPE) - 15 sections of 4 uM thickness, dried overnight at 37°C onto charged/coated slides.

Special instructions:

Please label each slide with patient and block identifiers plus number them sequentially 1-15. Stain slides 1 and 15 with H&E and leave slides 2 to 14 unstained.

The request should be accompanied by the somatic mutation request form (above) and a copy of the original histopathology report.

Turnaround time:

7 business days from receipt of sections by the testing laboratory.

Price:

This test has a Medicare rebate which, subject to the requirements of the Medicare descriptor being met, may cover all or part of the cost.

Rebate:

The Medicare details, including descriptor and schedule fee, are listed under MBS item 73337.

Click here for our billing policy.