Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score® test

Denis Horgan; Paul Hofman; Patrizio Giacomini; France Dube; Jaya Singh; Daniel Schneider; Tanya Hills; Jennifer Faikish; Marc Van Den Bulcke; Umberto Malapelle; Maciej Gajewski; Vivek Subbiah

doi:10.1515/dx-2024-0127

Article

Challenges and barriers for the adoption of personalized medicine in Europe: the case of Oncotype DX Breast Recurrence Score^® test

Denis Horgan , Paul Hofman , Patrizio Giacomini , France Dube , Jaya Singh , Daniel Schneider , Tanya Hills , Jennifer Faikish , Marc Van Den Bulcke , Umberto Malapelle , Maciej Gajewski and Vivek Subbiah

Published/Copyright: December 17, 2024

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From the journal Diagnosis Volume 12 Issue 2

Abstract

Personalized medicine, aiming to tailor treatments based on individual patient characteristics, holds immense potential in oncology. However, its widespread adoption in Europe faces numerous challenges, as illustrated by the case study of the Oncotype DX Breast Recurrence Score^® assay, a genomic test for breast cancer. This manuscript delineates the multifaceted obstacles encountered during the introduction of the Oncotype DX^®test (Oncotype DX Breast Recurrence Score test) in Europe from 2004 to 2018. In June 2018, the TAILORx results were published in the New England Journal of Medicine (Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379:111–21, Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019;380:2395–405), and reported that among 6,711 women with hormone-receptor–positive, HER2–negative, node–negative breast cancer and a midrange recurrence score of 11–25 on the Oncotype DX assay, endocrine therapy was not inferior to chemoendocrine therapy, which provides evidence that adjuvant chemotherapy was not beneficial in these patients. Through a comprehensive analysis of clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study sheds light on the intricate dynamics influencing the adoption of personalized medicine technologies. This article examines the various obstacles encountered during the introduction of the Oncotype DX Breast Cancer Assay in Europe from 2004 to 2018. By analyzing clinical evidence, commercial presence, reimbursement mechanisms, guideline recommendations, regulatory pathways, and local experiences, this study reveals the complex factors that influence the adoption of personalized medicine technologies. By highlighting these challenges, this article offers valuable insights into strategies to facilitate the integration of innovative diagnostic tools into clinical practice across Europe, ultimately leading to improved treatment decision-making for cancer patients.

Keywords: personalized medicine; Oncotype DX; cancer care; clinical integration; reimbursement mechanisms

Corresponding author: Denis Horga, European Alliance for Personalised Medicine, Brussels, Belgium; and 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, India, E-mail: denishorgan@euapm.eu

Funding source: European Commission EU4Health Program 2021â€“2027

Award Identifier / Grant number: 101080009

Research ethics: Not applicable.
Informed consent: Not applicable.
Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Use of Large Language Models, AI and Machine Learning Tools: None declared.
Conflict of interest: The authors state no conflict of interest.
Research funding: This research was funded by the CAN.HEAL project through the European Commission EU4Health Program 2021–2027 under Grant No. 101080009.
Data availability: Not applicable.

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Received: 2024-07-26

Accepted: 2024-11-18

Published Online: 2024-12-17

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Articles in the same Issue

https://doi.org/10.1515/dx-2024-0127

Keywords for this article

personalized medicine; Oncotype DX; cancer care; clinical integration; reimbursement mechanisms