The interim results were presented by Professor Åslaug Helland of Oslo University Hospital at the 2025 ASCO Annual Meeting.

“This study helps to explore the relevance of MRD as an indicator of disease activity for patients with unresectable stage III NSCLC. These early results underscore the potential of using Medicover Genetics’ ctDNA-based MRD assay as a tool for identifying patients at high risk of relapse who may benefit from intensified or tailored interventions,” says Professor Åslaug Helland, MD, PhD, Oslo University Hospital.

The interim results present a key milestone towards clinical validation of Medicover Genetics’ MRD assay and commercialization.

“Developing our liquid biopsy portfolio is a key pillar of our genetics strategy, with clinical validation being an important part. The initial results from the DART study are an important step in that direction. Looking ahead, we will continue to develop assays for a range of clinical applications, including therapy selection and MRD detection, and to establish their clinical validity across various cancer types through dedicated clinical studies,” says Staffan Ternström, COO, Diagnostics Services, Medicover.

For further information, please contact:
Hanna Bjellquist, Head of Investor Relations
+46 703 033 272
hanna.bjellquist@medicover.com

About the DART study
The DART study is a multicenter phase II clinical trial including 85 patients with unresectable stage III non-small cell lung cancer (NSCLC) across multiple sites in Europe. All participants received chemoradiotherapy (CRT) followed by durvalumab consolidation therapy.

Longitudinal plasma samples were collected at baseline (pre-CRT), at the initiation of durvalumab, and at predefined timepoints during durvalumab treatment and surveillance. The samples were analyzed using Medicover Genetics’ novel, tumor-agnostic ctDNA-based MRD assay, which evaluates 293 genes and is tailored to each patient’s individual biomarker profile using hybrid capture-based sequencing.

The interim analysis included 20 patients who completed all scheduled blood draws, totaling 138 plasma samples. Key findings include:

• Detectable ctDNA in at least one plasma sample during the first four months after chemoradiotherapy was significantly associated with shorter progression-free survival (PFS) (HR: 4.7; 95% CI: 1.6–13.1; p = 0.004).
• Presence of ctDNA at four months post-CRT was also linked to shorter progression-free survival (HR: 3.77; 95% CI: 1.32–10.74; p = 0.013).
• In contrast, ctDNA detection one month post-CRT was not significantly associated with reduced PFS (HR: 2.23; 95% CI: 0.78–6.36; p = 0.13).
• Detection of ctDNA during the first four months post-CRT was associated with significantly increased odds of death within 24 months (OR: 16.48; 95% CI: 1.29–1000.51; p = 0.017).

These findings underscore the potential of ctDNA-based MRD assessment as a prognostic biomarker to identify high-risk patients and guide more tailored interventions in this population.

Ongoing Medicover work regarding the DART study is now focusing on completing the MRD testing for the entire patient cohort.

The abstract of the study can be found here: https://meetings.asco.org/abstracts-presentations/253040

About Professor Åslaug Helland and the “Translational Studies on Solid Tumours” Group
Professor Åslaug Helland, MD, PhD, is a thoracic oncologist and Research Director at the Oslo Comprehensive Cancer Centre, and Professor at the University of Oslo. She leads the national centre for clinical cancer research (MATRIX) and several lung cancer projects in Norway, and heads several investigator-initiated trials, including the DART and IMPRESS-Norway studies.

The “Translational Studies on Solid Tumours” Group at Oslo University Hospital, focuses on lung, pancreatic and pan-cancer projects (https://ous-research.no/helland/). The team uses advanced techniques on material from investigator-initiated trials to identify prognostic and predictive biomarkers that improve treatment precision and reduce side effects, ultimately leading to better patient care.

Medicover is a leading international healthcare and diagnostic services company and was founded in 1995. Medicover operates a large number of ambulatory clinics, hospitals, specialty-care facilities, laboratories and blood-drawing points and the largest markets are Poland, Germany, Romania and India. In 2024, Medicover had revenue of €2,092 million and more than 47,000 employees. For more information, go to www.medicover.com