Biomarker testing is moving faster than ever. Is Europe keeping up?
Published: 20 June 2026 | Reading time: 8 minutes
Why is biomarker testing becoming so central in lung cancer?
For many years, biomarker testing was viewed as a specialist part of lung cancer care, associated mainly with advanced disease and a small number of targeted treatments. That is no longer the case. Today it shapes decisions about surgery, targeted therapies, immunotherapy, recurrence monitoring and clinical trial access, and it is increasingly relevant in both advanced and earlier-stage disease.
The science is moving quickly alongside it. New biomarkers continue to emerge, testing technologies are becoming more sophisticated, blood-based testing is expanding, and biomarker-guided treatments are moving into earlier stages of the disease. All of this points to one straightforward reality: access to treatment begins with access to testing.
What is changing in biomarker testing?
Several developments over the past 18 months show how rapidly the field is evolving:
Biomarker testing moving into earlier-stage disease
Increased use of comprehensive next-generation sequencing (NGS)
Growing interest in RNA sequencing alongside DNA testing
Expansion of liquid biopsy and circulating tumour DNA (ctDNA) testing
New evidence supporting repeat testing at progression
A growing list of actionable biomarkers and targeted treatments
Taken together, these shifts are changing expectations around what good biomarker testing looks like.
Biomarker testing is no longer just for advanced lung cancer
One of the clearest recent shifts is the growing role of biomarker testing in resectable and earlier-stage non-small cell lung cancer (NSCLC).
In June 2026, the National Comprehensive Cancer Network (NCCN) updated its NSCLC guidelines (Version 6.2026) to recommend RET fusion testing as part of biomarker evaluation for people with resectable or early-stage disease, and to recommend selpercatinib for eligible people with early-stage RET fusion-positive disease. The update follows positive results from the Phase 3 LIBRETTO-432 trial, which found that adjuvant selpercatinib significantly improved event-free survival in RET fusion-positive NSCLC after definitive local treatment.
The implications reach beyond RET. As more targeted therapies move into earlier-stage disease, identifying biomarkers before or shortly after surgery becomes part of routine decision-making rather than a late-stage consideration. The same pattern played out with EGFR and ALK; RET now joins a growing list of alterations shaping treatment decisions outside the metastatic setting.
Read more: RET fusion-positive lung cancer: a field transformed by science
Why is comprehensive biomarker testing becoming the expectation?
Historically, testing often focused on one biomarker at a time. Today the conversation centres on comprehensive genomic profiling using NGS, which assesses many biomarkers from a single sample rather than testing for one alteration at a time. The reason is straightforward: the number of clinically relevant biomarkers keeps growing.
Current biomarker panels may include:
EGFR
ALK
ROS1
RET
MET exon 14
KRAS G12C
BRAF V600E
HER2
NTRK
NRG1
Researchers continue to identify resistance mechanisms and emerging biomarkers that may influence treatment decisions or clinical trial eligibility. As the list of treatment options expands, the case for testing comprehensively rather than selectively grows with it.
Genomic profiling is only one strand of biomarker testing, though. Alongside it sits PD-L1 (programmed death-ligand 1), a protein measured on the surface of tumour cells rather than a change in the DNA inside them. It is assessed by immunohistochemistry rather than by sequencing, and it answers a different question. Where the genomic panel points towards targeted therapies, PD-L1 points towards immunotherapy, with the share of tumour cells expressing the protein helping to indicate who is most likely to benefit and whether immunotherapy is given alone or alongside chemotherapy.
This is why guidelines recommend PD-L1 testing across non-small cell lung cancer, not only for those being considered for a targeted treatment. Comprehensive testing, in practice, means running both strands together: genomic testing to find actionable alterations, and PD-L1 testing to guide immunotherapy. One without the other leaves part of the picture unseen.
Source: NCCN Guidelines Insights: Non-Small Cell Lung Cancer, Version 7.2025 (JNCCN)
NCCN Clinical Practice Guidelines in Oncology, Non-Small Cell Lung Cancer (free NCCN account required; the NSCLC guideline is listed under the lung cancer guidelines)
Read more: Why biomarker testing should be routine in all NSCLC
Are some actionable biomarkers being missed?
Sometimes, recent research suggests, the answer is yes. A study published in the journal Lung Cancer analysed more than 1,500 cases of non-squamous NSCLC using both DNA and RNA sequencing, and identified NRG1 fusions in 0.8% of cases. Earlier estimates had put the figure between 0.2% and 0.3%.
The gap looks small, but NRG1 fusions are actionable alterations, with targeted treatment options now available in some settings. The finding raises a pointed question for any testing programme: are current approaches catching every alteration that could change a treatment decision?
Why is RNA sequencing attracting more attention?
The NRG1 study points to another trend. Experts are increasingly asking not only whether testing has been done, but how. Many genomic tests focus primarily on DNA, yet some gene fusions are difficult to detect with DNA testing alone. RNA sequencing can improve detection of certain fusion-driven cancers and identify alterations that may otherwise be missed.
This does not make DNA testing inadequate. It does mean that testing strategies continue to evolve, and that the choice of platform can determine what is found. For health systems working to widen access to precision medicine, RNA sequencing is likely to move up the agenda.
The same gap is now seen in blood-based testing. When the American Society of Clinical Oncology published its 2026 guideline on ctDNA testing, one clinician noted that it focused on DNA and said little about circulating tumour RNA (ctRNA), which can pick up fusions that DNA testing misses. A prospective study in metastatic non-squamous NSCLC put a number to this: adding ctRNA to a ctDNA liquid biopsy increased detection of confirmed gene rearrangements by 28.6% over ctDNA alone.
The study tested a single commercial platform and was funded by the company that makes it, and the authors note its findings may not extend to other liquid biopsy platforms. Still, it points the same way as the tissue data. Whether in tissue or in blood, how a sample is analysed can decide whether a fusion is found.
How is liquid biopsy changing lung cancer care?
Liquid biopsy has become one of the fastest-moving areas in the field. Instead of analysing tissue, it examines circulating tumour DNA (ctDNA) in a blood sample. It began as an option for cases where tissue samples were limited, but its role has widened considerably.
Today, liquid biopsy is used to:
Identify actionable biomarkers
Detect resistance mechanisms
Support treatment selection
Monitor disease progression
Assess minimal residual disease
Investigate recurrence risk
In many settings it is now seen as complementary to tissue testing rather than a replacement for it.
In June 2026, the American Society of Clinical Oncology published its first clinical practice guideline on ctDNA testing in solid tumours and lymphoma, setting out where the test belongs. It supports ctDNA when a tissue biopsy is difficult, risky or too slow, or when a drug’s approved indication calls for it, and advises confirming negative or inconclusive results on tissue. The guideline is candid that the test’s clinical validity is well established while evidence that acting on the results improves outcomes remains limited, and it recommends against using ctDNA as a general replacement for tissue analysis.
Source: Lockwood et al, JCO Oncology Practice, 2026 (DOI 10.1200/OP-26-00311)
Can blood tests predict recurrence after surgery?
One of the more striking developments of 2026 involves ctDNA in early-stage disease. A prospective study of 153 people with clinical Stage I NSCLC, published in the Journal of Thoracic Oncology, found that detectable ctDNA before surgery was associated with a significantly higher risk of recurrence. Overall two-year recurrence-free survival was 84.2%, falling to 69.1% among those with detectable ctDNA before surgery.
The findings suggest ctDNA could help identify people who might benefit from closer monitoring or additional treatment. Further research is needed, but studies like this show biomarker testing moving beyond treatment selection alone.
Could blood tests help identify lung cancer years before diagnosis?
Researchers are also testing whether blood-based biomarkers could support earlier detection and risk prediction. A major study published in Cell analysed plasma protein data from more than 48,000 participants and identified a 14-protein signature in the blood that could flag a future lung cancer diagnosis more than five years in advance. The signature held across multiple populations, including people who would not usually be considered high risk.
The approach remains investigational, but it shows how far biomarker science is reaching beyond treatment selection, into risk prediction and prevention.
Read more: Blood test predicts lung cancer five years early
Are more people receiving biomarker testing?
There is encouraging news here. Recent real-world data suggest testing rates are improving. The MYLUNG Protocol 2 study, which looked at biomarker testing in metastatic NSCLC across a US community oncology network, found:
98.8% received testing for at least one biomarker
79% received at least one result before first-line treatment
NGS use rose substantially compared with earlier reports, from 37% to 73%
Real gaps remain, though. Not everyone received the comprehensive, guideline-recommended testing they should, access to advanced technologies still varies, and turnaround times differ from one health system to the next.
These gaps are especially visible in Europe. A 2025 assessment by the PCM4EU consortium, covering 14 European countries, found that only four reported equitable access to molecular diagnostics, with reimbursement, limited testing capacity and uneven access to treatments and trials the recurring barriers. A separate review across eleven European countries found that while predictive testing now features in national guidelines almost everywhere, how comprehensive those recommendations are, and which approved therapies are actually available, still varies from country to country.
Why does access remain one of the biggest challenges?
Scientific progress only reaches people when testing is available, affordable and delivered consistently. Across Europe, that is not yet the case. Access remains uneven for comprehensive NGS, RNA sequencing, liquid biopsy, molecular pathology expertise, and the targeted therapies tied to biomarker results. The consequence is that people with the same diagnosis can face very different options depending on where they live.
For Lung Cancer Europe, this sits at the centre of the access agenda. Testing is not simply a laboratory process. It is the gateway to treatment, clinical trial participation and precision medicine.
Read more: FAST NGS pilot launched at Metaxa Hospital in Greece
What should advocates, policymakers and healthcare professionals focus on next?
Several priorities are coming into focus:
Expanding access to comprehensive NGS testing
Improving access to RNA sequencing where appropriate
Supporting the responsible use of liquid biopsy
Reducing turnaround times
Encouraging repeat testing when clinically appropriate
Improving reimbursement for diagnostics
Linking testing pathways to treatment access
Reducing inequalities between countries and regions
As biomarker testing evolves, access to testing will increasingly shape access to treatment itself.
Looking ahead
Biomarker testing is no longer a niche corner of lung cancer care. It now runs through the whole pathway, from diagnosis and surgery to treatment selection, recurrence monitoring and clinical trial access. The science keeps advancing, the technologies keep improving, and the list of actionable biomarkers keeps growing. The challenge for Europe is to ensure that access to testing keeps pace.
Further reading
Why biomarker testing should be routine in all NSCLC
RET fusion-positive lung cancer: a field transformed by science
FAST NGS pilot launched at Metaxa Hospital in Greece
A lung cancer mutation that has resisted treatment for decades may finally have a drug
Blood test predicts lung cancer five years early