Description of Medical ServiceNext 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 ConditionLung 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 ApplicationNew MBS item
Medical Service TypeInvestigative
Previous Application Number/sNot Applicable
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