Test for these biomarkers in lung cancer patients

3 minute read


Australia’s first molecular testing guidelines for lung cancer streamline early and late-stage care.


Doctors have clear recommendations for molecular testing in lung cancer patients at different stages of their disease, thanks to Australia’s first guidelines for care.

Professor Wendy Cooper, lead author and Sydney pathologist, said lung cancer treatment had advanced significantly in recent years, which has led to increasingly complex treatment plans.

“Yet, evidence shows that biomarker-driven therapies can significantly improve survival rates and treatment responses compared to traditional methods,” she said.

“Early and accurate identification of genetic mutations in biomarkers such as EGFR, ALK, ROS1, MET, RET, NTRK, HER2, BRAF, KRAS and PD-L1 enables patients to receive the most effective care with tailored solutions that are targeted specifically to their tumour, potentially avoiding less effective and toxic treatments.”

The Molecular Testing of Lung Cancer in Australia report, developed by the Royal College of Pathologists of Australasia and the Thoracic Oncology Group of Australasia, gave 16 recommendations that outlined which molecular tests to perform, the best timing of tests and best practices for test performance.

Routine testing in advanced stage non-squamous NSCLC should include EGFR, BRAF, KRAS, ERBB2 (HER2), ALK, ROS1, MET, RET and NTRK and PD-L1, the report said.

“This includes any advanced stage lung carcinoma with an adenocarcinoma component. For example, non-small cell carcinoma with squamous and glandular   differentiation or where an adenocarcinoma cannot be excluded (e.g., a small biopsy/cytology diagnosis of NSCLC-NOS).”

More comprehensive testing could be done in these patients, especially if no gene variants are found in the above tests.

These tests should also be considered for patients who have been diagnosed with lung squamous cell carcinoma on small biopsy or cytology and whose clinical profile raises flags for driver mutation, such as a non-smoker under the age of 50.

Doctors are advised to test for resistance mechanisms in patients progressing on any targeted therapy, if tissue is available. If not, plasma based ctDNA should be considered.

Patients with advanced squamous cell carcinoma on biopsy should “at a minimum” undergo MET and PD-L1 testing.

The authors did not recommend biomarker testing for patients with pure small cell carcinoma.

Certain tests were also required for immunotherapy, according to the report.

“PD-L1 IHC for assessment of tumour proportion score should be undertaken in all advanced stage/metastatic NSCLC and stage IB-III NSCLC, regardless of histology,” it said.

“Molecular biomarker status is also required for immunotherapy treatment decisions in non-squamous NSCLC (e.g., EGFR, ALK, ROS1).

“There is currently no routine clinical role for Tumour Mutation Burden (TMB) or Microsatellite Instability (MSI) testing in NSCLC in Australia.”

Medical oncologist at Sydney’s Royal North Shore Hospital, Professor Nick Pavlakis, said adopting the recommendations would ensure every lung cancer patient had access to high-quality molecular testing.

“Standardising testing means faster, more precise care, giving patients the best chance at improved outcomes and quality of life,” said the chair of the Thoracic Oncology Group of Australasia’s board of directors.

Lung cancer is the fifth most diagnosed cancer in Australia but causes the highest number of cancer-related deaths, the authors said.

Royal College of Pathologists of Australasia president Associate Professor Trishe Leong said the best practice recommendations would improve consistency in molecular testing, align practices with global best standards and enhance patient care.

“Without local recommendations from a trusted source, laboratories and clinicians may struggle to determine best practice,” Professor Leong said. 

Molecular Testing of Lung Cancer in Australia, 2025

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