Biomarkers

Context

Biomarker testing in the era of precision medicine

At the start of this century, the survival rate for patients with stage 4 lung cancer was a bleak one year. However, as our understanding of lung cancer biomarkers has grown, there has been a significant shift in both prognosis and survival rates for these patients (Batra & Nathany, 2025). The approval of the first targeted therapy for lung cancer in Europe in 2005 marked a turning point, fundamentally transforming clinical practice and ushering in a new era of precision medicine (de Jager, Lancet, 2024).

Thanks to the development of advanced technologies, it is now possible to perform large-scale, high-quality genetic and genomic testing, enabling clinicians to identify and target an increasing number of mutations and oncogenic drivers. For people living with advanced-stage non-small-cell lung cancer (NSCLC) in Europe, the treatment landscape has expanded to include numerous approved therapies targeting different oncogenic drivers. However, access to these therapies and the biomarker tests that guide their use varies enormously across Europe, raising concerns about equity in cancer care.

According to the ASCO Living Guideline (2026), the availability of biomarker testing results is essential for selecting an appropriate treatment strategy. Ideally, this includes comprehensive next-generation sequencing (NGS) alongside immunohistochemistry (IHC) for programmed death ligand 1 (PD-L1), HER2, and MET. Together, these tests guide treatment decisions, enabling either targeted therapy for NSCLC with actionable driver mutations or immunotherapy-based approaches for tumours without actionable alterations.

Access to complete molecular profiling before initiating first-line therapy has been associated with improved overall survival and greater cost-effectiveness in care delivery. Combining tissue- and blood-based molecular profiling can increase diagnostic yield and improve the likelihood of obtaining actionable results prior to treatment initiation. Platforms incorporating RNA sequencing further enhance the detection of actionable gene fusions.

In contrast, single-gene polymerase chain reaction (PCR) testing should generally be avoided outside of resource-limited settings, as it has lower sensitivity for detecting actionable genomic alterations and is inefficient in its use of tissue.

Methods

Techniques used for biomarker testing in lung cancer

There are several ways to test for lung cancer biomarkers, including analysing samples for one or many alterations through sequencing. This can be done on tumour tissue or through a blood test called a liquid biopsy, which is less invasive compared to a tissue biopsy (Bayle et al. 2023).

Source: Lim et al. 2018; 2024 IASLC Global Biomarker Testing Survey

Across Europe

Quality of biomarker testing in Europe

The quality of biomarker testing is another key metric, based on ISO accreditation and participation in at least one European Quality Assessment (EQA) scheme. The lowest proportions of ISO-accredited facilities were found in Bulgaria, Croatia and Romania, and EQA participation was lowest in Slovakia (50% of testing facilities) and Greece (56%). Reasons for not participating in quality schemes included lack of funding and lack of requirement at the national level for EQA participation or ISO accreditation (Normanno et al. 2022).

The State of Biomarker Testing in Europe: Quality and Access. Source: EFPIA, 2022.

This map illustrates the ease of access and the quality of biomarker testing across all EU countries and the UK. There are still big divides in Europe. Northern and Western European countries generally perform better in biomarker testing, reflecting their higher investment in healthcare. Southern and Central European countries, as well as the Baltic states, tend to have more variability in access to test infrastructure and funding. Countries in Eastern Europe require more significant structural changes to achieve equity in access to quality biomarker testing.

EFPIA: Unlocking the potential of precision medicine in Europe — improving cancer care through broader access to quality biomarker testing (2022) →

LuCE initiative

FAST-NGS: Generating real-world evidence to improve access to biomarker testing

Timely biomarker testing is fundamental to delivering precision oncology. However, despite advances in molecular diagnostics, many patients across Europe continue to experience delays in receiving next-generation sequencing (NGS) results, which can postpone biomarker-informed treatment decisions and contribute to inequities in access to personalised care.

To address this challenge, Lung Cancer Europe has launched FAST-NGS (Faster Analysis of Sequencing Turnaround Time), a real-world observational project designed to evaluate how biomarker testing pathways can be optimised in routine clinical practice. The project compares the conventional "send-out" NGS testing pathway with an in-house testing model, assessing turnaround times, workflow efficiency, and the practical feasibility of implementing local NGS testing in a community hospital setting.

Although the initial focus is on non-small cell lung cancer (NSCLC), the NGS platform has pan-cancer capabilities, creating opportunities to extend the initiative to additional tumour types and European healthcare settings. As Lung Cancer Europe explores expansion to further pilot sites, FAST-NGS aims to provide practical evidence that can inform policy, improve diagnostic pathways, and support equitable access to precision medicine across Europe.

Read more about the FAST-NGS initiative →