Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring

Abstract

Liquid biopsy (LB) is a minimally invasive method which aims to detect circulating tumor-derived components in body fluids. It provides an alternative to current cancer screening methods that use tissue biopsies for the confirmation of diagnosis. This paper attempts to determine how far the regulatory, policy, and governance framework provide support to LB implementation into healthcare systems and how the situation can be improved. For that reason, the European Alliance for Personalised Medicine (EAPM) organized series of expert panels including different key stakeholders to identify different steps, challenges, and opportunities that need to be taken to effectively implement LB technology at the country level across Europe. To accomplish a change of patient care with an LB approach, it is required to establish collaboration between multiple stakeholders, including payers, policymakers, the medical and scientific community, and patient organizations, both at the national and international level. Regulators, pharma companies, and payers could have a major impact in their own domain. Linking national efforts to EU efforts and vice versa could help in implementation of LB across Europe, while patients, scientists, physicians, and kit manufacturers can generate a pull by undertaking more research into biomarkers.

Analytical device miniaturization for the detection of circulating biomarkers

“…To promote the clinical translation of liquid biopsy tests, the specific clinical needs, regulatory guidelines and reimbursement models, among others 184 , 185 , should also be considered. In particular, translating pre-clinical prototypes into clinical platforms requires careful product development strategies.…”

Real-world EGFR testing practices for non-small-cell lung cancer by thoracic pathology laboratories across Europe

“…An increase in the practice of liquid biopsy testing for EGFR mutation detection both at diagnosis and at tumour progression may be beneficial for improved TATs. 25 There is also an urgent need to increase the prevalence of NGS testing comparatively to single-test sequencing, considering the recommendations included in the ESMO guidelines for both tissue and cell-free DNA, and the increased risk of obtaining false-negative results when using single-test sequencing for EGFR genomic alteration detection. Moreover, using NGS enables identification of multiple other biomarkers relevant for the patients’ treatment using one test.…”

Analysis of Cell-Free DNA to Predict Outcome to Bevacizumab Combination Therapy in Metastatic Colorectal Cancer Patients

“…Future studies should also address issues related to low tumor content in plasmaderived cfDNA. An optimized and universal scaling method could be a powerful tool, especially in the clinical context, where patient tumor samples might not be available, and with the aim to progress towards less invasive prognostic methods 35 .…”