Identifying the Steps Required to Effectively Implement Next-Generation Sequencing in Oncology at a National Level in Europe

Abstract

Next-generation sequencing (NGS) may enable more focused and highly personalized cancer treatment, with the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines now recommending NGS for daily clinical practice for several tumor types. However, NGS implementation, and therefore patient access, varies across Europe; a multi-stakeholder collaboration is needed to establish the conditions required to improve this discrepancy. In that regard, we set up European Alliance for Personalised Medicine (EAPM)-led expert panels during the first half of 2021, including key stakeholders from across 10 European countries covering medical, economic, patient, industry, and governmental expertise. We describe the outcomes of these panels in order to define and explore the necessary conditions for NGS implementation into routine clinical care to enable patient access, identify specific challenges in achieving them, and make short- and long-term recommendations. The main challenges identified relate to the demand for NGS tests (governance, clinical standardization, and awareness and education) and supply of tests (equitable reimbursement, infrastructure for conducting and validating tests, and testing access driven by evidence generation). Recommendations made to resolve each of these challenges should aid multi-stakeholder collaboration between national and European initiatives, to complement, support, and mutually reinforce efforts to improve patient care.

Fusion‐positive non‐small cell lung carcinoma: Biological principles, clinical practice, and diagnostic implications

“…Access to molecular testing, notably NGS, varies according to place where the patient lives and is taken into care by a physician 201 . In large cities, molecular testing can usually be done rapidly in expert centers.…”

“…Access to molecular testing, notably NGS, varies according to place where the patient lives and is taken into care by a physician. 201 In large cities, molecular testing can usually be done rapidly in expert centers. However, many cities in the world do not have molecular pathology platforms and samples need to be sent to external centers.…”

Daily Practice Assessment of KRAS Status in NSCLC Patients: A New Challenge for the Thoracic Pathologist Is Right around the Corner

“…When considering the increasing number of genes to be evaluated at diagnosis or at tumor progression, NGS must be used as a priority. However, setting up and using NGS systematically can still be associated with a number of constraints, which will be detailed below [ 191 ].…”

“…Thus, according to the sample size and type, and/or the percentage of tumor cells, the different technologies must be well controlled to make a pathological and a molecular testing report in a short TAT. The accessibility to NGS in daily routine practice and thus assessment of the KRAS status is variable from one laboratory to another and from one country to another [ 191 ].…”

“…Considering that other genes of interest (notably KRAS and HER2 ) are present in the majority of NGS panels, it is obvious that NGS is the better approach for systematically gaining access to the KRAS status for NS-NSCLC [ 209 ]. However, NGS at baseline or even at progression and at recurrence is not currently possible in all countries [ 191 , 212 ]. Moreover, one drawback of doing some molecular tests, notably when evaluating the KRAS status, is that the therapeutic molecule targeting KRAS G12C is not yet available in routine clinical practice and is currently mandatory only for inclusion into clinical trials using KRAS inhibitors.…”