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Perspective

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

by
Denis Horgan
1,2,*,
Tanja Čufer
3,
Francesco Gatto
4,
Iwona Lugowska
5,
Donatella Verbanac
6,
Ângela Carvalho
7,8,
Jonathan A. Lal
2,9,
Marta Kozaric
1,
Sinead Toomey
10,
Hristo Y. Ivanov
11,
John Longshore
12,
Umberto Malapelle
13,
Samantha Hasenleithner
14,
Paul Hofman
15 and
Catherine Alix-Panabières
16
1
European Alliance for Personalised Medicine, 1040 Brussels, Belgium
2
Department of Molecular and Cellular Engineering, Jacob Institute of Biotechnology and Bioengineering, Faculty of Engineering and Technology, Sam Higginbottom University of Agriculture, Technology and Sciences, Prayagraj 211007, India
3
Medical Faculty, University of Ljubljana, 1000 Ljubljana, Slovenia
4
Department of Oncology-Pathology, Karolinska Institute, 171 64 Stockholm, Sweden
5
Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute and Oncology Centre (MSCI), 02781 Warsaw, Poland
6
Department of Medical Biochemistry and Hematology, Faculty of Pharmacy and Biochemistry, University of Zagreb, Ante Kovačića 1, 10000 Zagreb, Croatia
7
i3S—nstituto de Investigação e Inovação em Saúde, Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal
8
INEB—Instituto de Engenharia Biomédica, Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal
9
Institute for Public Health Genomics, Department of Genetics and Cell Biology, GROW School of Oncology and Developmental Biology, Faculty of Health, Medicine and Life Sciences, Maastricht University, 6211 LK Maastricht, The Netherlands
10
Department of Molecular Medicine, RCSI University of Medicine and Health Sciences, Beaumont Hospital, Smurfit Building, D09 Dublin, Ireland
11
Department of Paediatric and Medical Genetics, Medical University, 4000 Plovdiv, Bulgaria
12
Astra Zeneca, 1800 Concord Pike, Wilmington, DE 19803, USA
13
Department of Public Health, University of Naples Federico II, 80137 Naples, Italy
14
Institute of Human Genetics, Diagnostic and Research Center for Molecular BioMedicine, Medical University of Graz, 8036 Graz, Austria
15
Laboratory of Clinical and Experimental Pathology, FHU OncoAge, Pasteur Hospital, University Côte d’Azur, CEDEX 01, 06001 Nice, France
16
Laboratory of Rare Human Circulating Cells (LCCRH), University Medical Centre of Montpellier, 641 Avenue du Doyen Gaston Giraud, CEDEX 5, 34093 Montpellier, France
 
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*
Author to whom correspondence should be addressed.
Healthcare 2022, 10(9), 1714; https://doi.org/10.3390/healthcare10091714
Submission received: 19 July 2022 / Revised: 26 August 2022 / Accepted: 2 September 2022 / Published: 7 September 2022
(This article belongs to the Special Issue Redefining the Unmet Needs in Healthcare and the Regulatory Challenge)
Versions Notes

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.
Keywords: liquid biopsy; cancer; personalized medicine; technology; healthcare; policy framework; legislation; diagnosis; treatment; governance; implementation liquid biopsy; cancer; personalized medicine; technology; healthcare; policy framework; legislation; diagnosis; treatment; governance; implementation

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MDPI and ACS Style

Horgan, D.; Čufer, T.; Gatto, F.; Lugowska, I.; Verbanac, D.; Carvalho, Â.; Lal, J.A.; Kozaric, M.; Toomey, S.; Ivanov, H.Y.; et al. Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring. Healthcare 2022, 10, 1714. https://doi.org/10.3390/healthcare10091714

AMA Style

Horgan D, Čufer T, Gatto F, Lugowska I, Verbanac D, Carvalho Â, Lal JA, Kozaric M, Toomey S, Ivanov HY, et al. Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring. Healthcare. 2022; 10(9):1714. https://doi.org/10.3390/healthcare10091714

Chicago/Turabian Style

Horgan, Denis, Tanja Čufer, Francesco Gatto, Iwona Lugowska, Donatella Verbanac, Ângela Carvalho, Jonathan A. Lal, Marta Kozaric, Sinead Toomey, Hristo Y. Ivanov, and et al. 2022. "Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring" Healthcare 10, no. 9: 1714. https://doi.org/10.3390/healthcare10091714

APA Style

Horgan, D., Čufer, T., Gatto, F., Lugowska, I., Verbanac, D., Carvalho, Â., Lal, J. A., Kozaric, M., Toomey, S., Ivanov, H. Y., Longshore, J., Malapelle, U., Hasenleithner, S., Hofman, P., & Alix-Panabières, C. (2022). Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring. Healthcare, 10(9), 1714. https://doi.org/10.3390/healthcare10091714

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