TY - JOUR
T1 - Companion Diagnostics
T2 - State of the Art and New Regulations
AU - Valla, Vasiliki
AU - Alzabin, Saba
AU - Koukoura, Angeliki
AU - Lewis, Amy
AU - Nielsen, Anne Ahlmann
AU - Vassiliadis, Efstathios
N1 - Publisher Copyright:
© The Author(s) 2021.
PY - 2021
Y1 - 2021
N2 - Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
AB - Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
KW - Companion diagnostics
KW - IVDR
KW - In-vitro Diagnostic Medical Devices Legislation
KW - biomarkers
KW - diagnostic equipment
KW - diagnostic techniques and procedures
KW - diagnostic test approval
KW - in vitro diagnostics
KW - laboratory developed tests
KW - molecular diagnostic techniques
KW - precision medicine
UR - http://www.scopus.com/inward/record.url?scp=85116922969&partnerID=8YFLogxK
U2 - 10.1177/11772719211047763
DO - 10.1177/11772719211047763
M3 - Review article
AN - SCOPUS:85116922969
SN - 1177-2719
VL - 16
JO - Biomarker Insights
JF - Biomarker Insights
ER -