A comprehensive assessment of the existing landscape of personalized cancer medicine in the European Union, on behalf of the PCM4EU consortium

Background: In the growing field of personalized cancer medicine (PCM), successful implementation requires access to advanced molecular diagnostics and treatments. The Personalized Cancer Medicine for all EU Citizens (PCM4EU) consortium was established to facilitate broad implementation of PCM across Europe. This study aimed to assess the current status of PCM from the perspectives of health care professionals and patients. Materials and methods: Three distinct questionnaires were developed for medical oncologists, pathologists, and patients, focusing on molecular diagnostics use in countries participating in the PCM4EU consortium. Adult patients with locally advanced or metastatic cancer who underwent molecular diagnostics were eligible to complete the patient questionnaire. Results: Between July 2024 and February 2025, 14 out of 15 countries completed the medical oncologist and pathologist questionnaires. Equitable access to molecular diagnostics was reported by 4 out of 14 countries, with limited access to treatments, clinical trials, or reimbursement issues identified as common barriers. Tumor-specific biomarkers matching approved targeted therapies were more often tested than tumor-agnostic biomarkers. Molecular tumor boards were established in 13 out of 14 countries. There was limited availability of complex biomarker testing techniques in several countries, and laboratories sometimes lacked accreditation by the International Organization for Standardization. A total of 288 patients from 16 countries completed the patient questionnaire. More comprehensible information regarding molecular diagnostics and better pre- and post-test genetic counseling were the main improvements reported by patients. Conclusions: By use of extensive questionnaires, we assessed the implementation of PCM in Europe and identified persistent inequalities, ranging from disparities in available biomarker testing techniques to their reimbursement, and shortcomings in communication to patients. By facilitating access to similar treatments across countries with the establishment of a Drug Rediscovery Protocol-like clinical trials network, and accelerating data generation by sharing data, patients in Europe are one step closer to equitable access to precision oncology.