The paper “Access and quality of biomarker testing for precision oncology in Europe” co-authored by ECPC Scientific Committee member, Ass. Prof. Nicola Normanno, ECPC Past President and Chair of Scientific Committed, Kathi Apostolidis, EFPIA Senior Manager Healthcare Systems & SMEs, Audrey Wolf, Raed Al Dierid, Zandra Deanse, Jenni Fairleye, Jörg Maas, Antonio Martinez, Holger Moch, Søren Nielsen, Thomas Pilz, Etienne Rouleau, Simon Patton, Victoria Williams, will be published in Volume 176, In progress (November 2022) of the European Journal of Cancer.

The paper evaluates the access to and quality of biomarker testing across Europe, following a survey conducted in 2020 by the International Quality Network for Pathology (IQN Path), the European Cancer Patient Coalition (ECPC) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), together with a consortium of industry and academic partners. The survey was conducted  across the 27 European countries (EU27) and the United Kingdom (UK) in order to analyse the current biomarker testing practices in solid tumours and identify country-specific shortcomings.

The research included a literature review on the current status of precision medicine treatment and testing in oncology, as well as interviews with key stakeholders, and two online surveys, one targeting laboratory managers and the other patients with cancer and patient advocates. The patient survey, proposed by ECPC, was successfully run during the acute covid-19 pandemic from February 2020 to September 2020 and was conducted among its members and patients with cancer, to characterize the patient experience along the cancer diagnostic journey. The survey included questions on the following:

  1. the level and quality of patient education on biomarker testing;
  2. the degree of patient satisfaction around the testing process;
  3. the availability of public reimbursement to cover the cost of biomarker testing;
  4. the availability different biomarker test technologies and test turnaround time (TAT).

The increasing availability of biomarkers and matched drugs is radically changing the diagnostic and therapeutic approach to cancer. The approval of new complex biomarkers, the need to identify rare genomic alterations and the introduction of the ‘tumour agnostic’ biomarkers is making the use of NGS technologies increasingly indispensable for tumour genomic profiling. The possibility for patients to access innovative therapies is directly linked to the availability of high quality biomarker tests. The highlights of the survey are:

  • The access to single biomarker tests is inadequate in many European countries.
  • In Europe, <10% of specimens requiring molecular testing are analysed with next generation sequencing.
  • Low participation in external quality assessment raises concerns about test quality.
  • Limited access to biomarker testing can preclude the access to precision medicines.

The survey data indicate the need for a call to action to ensure the clinical implementation of precision medicine in Europe. A  few general recommendations to improve the patients access to biomarkers have been presented:

  • A process should be developed for the parallel regulatory and reimbursement approval of the precision medicine and the associated biomarker test.
  • Investments in testing infrastructure and training of test personnel are definitely required.
  • An adequate budget must be identified to be allocated to biomarkers, to meet all needs.
  • A stringent system for verifying the quality of the tests must be implemented to guarantee patient safety.

These initiatives are urgent to remove the barriers to biomarker test access and therefore to guarantee equal access to the new therapeutic possibilities for all European patients, in the Europe’s Beating Cancer Plan.

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