TEST:

EarlyCDT®-Lung

The adoption of an autoantibody test as a liquid biopsy for early lung cancer screening in high-risk populations in Brazil led to increased costs and was not considered cost-effective under the thresholds commonly applied in the Brazilian context.

When considering these results alongside the all-cause mortality reduction shown in previous analyses, they indicate that this targeted approach to LCS might help improve the benefit-harm ratio through the introduction of biomarkers. Further refining selection criteria for low-dose CT screening might contribute to minimising the risk of overdiagnosis and overtreatment.

Using a longitudinal cohort from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) study, we have established that elevated autoantibodies can be detected an average of four years in advance of clinical presentation, and in some cases up to 8 years prior to clinical presentation. This is the first study to establish pre-diagnostic elevation of autoantibodies using samples from a longitudinal prospective clinical trial using a clinically validated and commercially available biomarker panel.

While advanced NSCLC patients benefit from targeted therapy, early-stage patients may undergo surgery followed by adjuvant cisplatin-based chemotherapy or stereotactic body radiotherapy (SBRT)...In conclusion, the review underscores the multidisciplinary approach required for effective lung cancer management. Advances in early detection, personalized treatment, and the integration of technology and biomarkers offer hope for improving outcomes and reducing the global burden of lung cancer.

In those diagnosed with lung cancer within 2 years of randomization the hazard ratio for all cause mortality was 0.615 (0.401,0.942) and for lung cancer 0.598 (0.378, 0.946). Further large-scale studies of the role of biomarkers to target lung cancer screening, in addition to LDCT, are likely to provide additional value.

The ECLS intervention is the most cost-effective screening alternative, with the highest probability of being cost-effective, when compared to no screening or LDCT screening. This result may change with modifications of the parameters, suggesting that the three alternatives considered in the main analysis are potentially cost-effective.

This review provides the first synthesised evidence to help guide LCS program design to minimise psychosocial harm for participants. Study heterogeneity and high risk of bias suggests that more robust testing of the impact of program design on psychosocial outcomes in real-world settings is needed. Future research should focus on developing feasible methods of managing the psychosocial experiences of LCS which complement the implementation requirements of large-scale screening programs.

Circulating proteins showed promise in predicting incident lung cancer and outperformed a standard risk prediction model and the commercialized EarlyCDT-Lung.

"Freenome...announced...it has acquired Oncimmune Ltd...with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures...The acquisition of Oncimmune Ltd provides Freenome with clinical and commercial resources to complement Freenome’s frontline screening efforts."

The iDx-lung study will evaluate biomarkers and build a prediction model for the early detection of lung cancer to improve current LDCT screening protocols. The team of academic and industrial partners have successfully completed the set-up phase of this large-scale translational study. Recruitment, sample collection and analysis is underway.

Stratified analysis indicated higher sensitivity (17%, 95% CI, 7.2-32.1) in subjects with blood drawn up to 1 year prior to diagnosis. In conclusion, our study does not support a role of the EarlyCDT-Lung test in identifying the high-risk subjects in ever-smokers for lung cancer screening in the EPIC and NSHDS cohorts.

All results were concentrated above Brazilian GDP per capita, indicating that this strategy was not cost-effective in Brazil. The screening with liquid biopsy would only become cost effective if the Brazilian lung cancer prevalence context was greater than 15%.