The ASPiRATION Study, led by the Thoracic Oncology Group of Australasia (TOGA), transformed how lung cancer is diagnosed and treated in Australia. By providing real-world evidence for next-generation sequencing (NGS), advocating for Medicare-funded genomic testing, and designing Best Practice Recommendations, TOGA helped embed precision medicine into national healthcare policy and clinical practice in as little as 5 years.
The Need for Change in Lung Cancer Molecular Testing
In 2020, molecular testing for newly diagnosed metastatic non-squamous non-small cell lung cancer (NSCLC) in Australia relied on sequential single-gene assays for EGFR, ALK, and ROS1.
While these tests enabled targeted treatment for some patients, they had key limitations:
Testing was slow and sequential, delaying treatment.
Many patients had insufficient tumour tissue for multiple tests.
Other mutations (BRAF, MET, RET, NTRK, HER2, KRAS G12C) were not routinely tested, but were delivering promising clinical trial results, suggesting they would soon be available for routine care.
International and early Australian data showed that NGS could identify all actionable mutations in a single test, enabling both precision treatment and clinical trial enrolment. But the absence of a national testing platform meant Australians would miss timely access to lifesaving targeted therapies.
The ASPiRATION Study: Establishing Real-World Evidence
Launched by TOGA in 2020, the ASPiRATION study was the first national multicentre prospective cohort study assessing the clinical impact of Comprehensive Genomic Profiling (CGP; a type of NGS) in metastatic NSCLC.
The study enrolled 1,000 patients from metropolitan and regional centres, ensuring equitable access to advanced molecular testing and personalised cancer care.
Study Design
Objective: Evaluate whether up-front CGP improves clinical outcomes and treatment decision-making.
Methods: Formalin Fixed Paraffin Embedded (FFPE) biopsy tissue was sent to a central testing facility for CGP, analysing hundreds of cancer-related genes in one assay.
Governance: Results were reviewed by a national Molecular Tumour Board (MTB) that advised clinicians on treatment and clinical trial options.
Access: Patients with actionable variants were referred for targeted therapies or trial enrolment.
Key Findings
Feasibility: Nationwide access to CGP is achievable using remote tissue referral and virtual tumour boards. Of particular relevance, the turnaround time for diagnostic tissue was reduced to 14 days or under, making the system feasible for first line treatment in metastatic NSCLC.
Clinical Utility: A proportion of patients had actionable genomic alterations only detected by CGP and accessed targeted therpaies through clinical trials and other access programs.
Equity: ASPiRATION provided access to genomic testing for regional, rural and remote patients, reducing geographical disparity in access.
Health System Readiness: ASPiRATION established workflows for testing and reporting that became the model for routine NGS use. Through an accompanying education program, that discussed available testing, and new targeted treatments, TOGA equipped healthcare professionals for ultimate rollout into standard care.
From Evidence to Policy: Influencing National Reimbursement
TOGA’s ASPiRATION study provided robust real-world evidence showing the clinical value, feasibility, and equity benefits of CGP and NGS. TOGA leveraged these findings to advocate for major policy changes, ultimately contributing to Medicare reimbursement for NGS testing in non-squamous NSCLC.
TOGA’s Policy and Advocacy Actions
Support for Medical Services Advisory Committee (MSAC) submission
TOGA supported the application for Medicare funding, submitting ASPiRATION data on diagnostic yield and clinical benefit.Public Consultation Feedback
TOGA endorsed the inclusion of multiple oncogenes (EGFR, ALK, ROS1, BRAF, MET, RET, NTRK, KRAS) in reimbursed NGS panels.Engagement with Pharmaceutical Benefits Scheme (PBS)
TOGA recommended that PBS criteria for tyrosine kinase inhibitors (TKIs) recognise NGS results, not just older testing methods.
Broader Clinical and System Impact
National Uptake of NGS
NGS is now a standard diagnostic tool for metastatic NSCLC across Australia.Enhanced Clinical Trial Access
ASPiRATION’s model—centralised testing and virtual tumour boards— was able to enhance access to clinical trials that provided targeted therapies not yet reimbursed on the PBS.Equity and Regional Inclusion
Remote tissue referral and digital MTBs made genomic testing accessible to regional and rural Australians.Policy Ripple Effect
ASPiRATION’s success has shaped other national precision medicine initiatives, including Omico’s Prospect platform.
From Policy to Practice: National Best Practice Recommendations
After the introduction of Medicare-funded NGS, TOGA and RCPA jointly released the 2025 Best Practice Recommendations for Molecular Testing of Lung Cancer in Australia.
These evidence-based guidelines standardise genomic testing across pathology laboratories and ensure equitable, high-quality care.
Key Features of the 2025 Recommendations
Comprehensive Mutation Coverage: Testing for EGFR, ALK, ROS1, BRAF, MET, RET, NTRK1-3, KRAS, and HER2 (ERBB2).
Integration of Immunotherapy Biomarkers: Assessment of PD-L1 and other markers to guide immunotherapy decisions.
Optimised Tissue Use: Encourages liquid biopsy (ctDNA) testing when tissue is limited.
Efficiency and Cost-Effectiveness: Streamlined testing pathways reduce redundancy and time to treatment.
These standards align policy, laboratory practice, and clinical care—ensuring that patients receive timely, evidence-based genomic testing.
Lessons in Research Translation
Stage | Activity | Outcome |
|---|---|---|
Discovery & Feasibility | Identified limits of sequential testing; designed ASPiRATION to assess real-world NGS use | Strong clinical and logistical evidence for NGS |
Implementation Research | Conducted national study using standardised testing pathways | Proved feasibility of nationwide CGP delivery |
Policy Engagement | Submitted evidence to MSAC and PBS; collaborated with clinical bodies | Supported Medicare funding for NGS in NSCLC |
Practice Integration | Co-authored RCPA–TOGA guidelines | Standardised molecular testing protocols |
Scaling | Fostered collaboration between clinicians, pathologists, and policymakers | Built a sustainable national precision oncology model |
Conclusion
TOGA’s ASPiRATION study is a benchmark in research translation—demonstrating how evidence-based advocacy can reshape national health policy and clinical practice.
Through its leadership in genomic testing, TOGA enabled equitable access to precision medicine for Australians with non small cell lung cancer (NSCLC). The resulting RCPA–TOGA guidelines ensure that this progress is both sustainable and consistently implemented.
This alignment of research, reimbursement, and practice marks a complete translational pathway—advancing cancer genomics and strengthening Australia’s position as a leader in precision oncology.
What’s next for precision medicine in lung cancer?
While first-line targeted therapies like tyrosine kinase inhibitors (TKIs) can control oncogene-driven metastatic NSCLC for months or years, disease progression eventually limits treatment options.
TOGA’s ASPiRATION-2 Liquid (ASPi-2L) will use liquid biopsy to monitor tumour molecular changes non-invasively, replacing or complementing traditional tissue biopsies. Over the next five years, ASPi-2L will recruit 500 Australians whose NSCLC has progressed after targeted therapy, using liquid biopsy to guide ongoing treatment and connect patients to PBS-funded therapies, clinical trials, or other programs. The study will assess the real-world benefits and cost-effectiveness of integrating liquid biopsy into standard care, while ensuring nationwide equity via telehealth, remote consent, and virtual Molecular Tumour Boards. ASPi-2L represents the next step in dynamic, personalised precision oncology for lung cancer.
TOGA continues to push the envelope in precision medicine offering real hope to people living with lung cancer. Please help support TOGA’s lung cancer and mesothelioma research.
