1634 – Comprehensive genomic profiling of non-small cell lung cancer tumour tissue specimens using next generation sequencing assays

Page last updated: 30 September 2020

Application Detail

Description of Medical Service

Next generation sequencing (NGS) assays facilitate the comprehensive genomic profiling (CGP) of tumour tissue through their ability to identify four classes of genomic alterations: base substitutions (single nucleotide variants); insertions and deletions; copy number alterations; and gene fusions (rearrangements). By simultaneously testing multiple genes for multiple types of genomic alterations, NGS assays provide clinicians with detailed information on the biomarker status of patients, including the presence of genomic alterations for which a targeted therapy is available. The use of CGP using NGS assays is also able to provide information on genomic signatures including tumour mutation burden and microsatellite instability. The consolidation of multiple molecular biomarker tests into a single NGS assay avoids the need to perform a sequence of biomarker tests. This may lead to a reduction in the number of procedures performed to obtain further biopsy material when the original sample is depleted.

Description of Medical Condition

Lung cancer is the fifth most commonly diagnosed cancer in Australia. Based on projections of lung cancer incidence outlined in the background document to the PD-(L)1 checkpoint inhibitor stakeholder meeting with the Department of Health 2019, there will be 12,990 new cases of lung cancer in Australia in 2020. There are two broad classes of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer. This application is focused on NSCLC. Patients with NSCLC that are diagnosed early may be managed by surgical removal (resection) of their tumour. In circumstances where surgical resection is not appropriate due to advanced disease, or when a patient experiences disease progression following surgical resection, management with systemic therapy is recommended. The selection of the appropriate systemic therapy to use in NSCLC patients is increasingly being guided by the identification of molecular biomarkers in a patient’s tumour. This application relates to the use of CGP of NSCLC tumour tissue using NGS assays in patients being considered for treatment with systemic therapy.

Reason for Application

New MBS item

Medical Service Type


Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1370 KB)
Application Form (Word 658 KB)

Consultation Survey

Consultation Survey (PDF 560 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation

PICO Confirmation (PDF 1337 KB)
PICO Confirmation (Word 209 KB)

Assessment Report


Public Summary Document


Meetings for this Application


10-11 December 2020
15-16 April 2021