4.6 Article

A Systematic Database Approach to Identify Companion Diagnostic Testing in Clinical Trials under the New In Vitro Diagnostic Medical Devices Regulation

Related references

Note: Only part of the references are listed.
Review Medicine, General & Internal

Biomarker and Companion Diagnostics-A Review of Medicinal Products Approved by the European Medicines Agency

Laura Patricia Orellana Garcia et al.

Summary: The study analyzed the information and recommendations related to biomarker testing, including CDx, in SmPCs and EPARs of EU medicinal products approved via the centralised procedure at EMA. The results showed varied levels of detail and presentation of information on biomarkers and diagnostic tests in the documents. Overall, there was transparent but sometimes heterogeneous reporting of CDx in the SmPC and EPAR.

FRONTIERS IN MEDICINE (2021)

Review Medicine, Research & Experimental

Companion Diagnostics: State of the Art and New Regulations

Vasiliki Valla et al.

Summary: Companion diagnostics show potential for improving drug development and precision medicine, but face challenges in clinical development and regulation. The European Union is implementing new regulations for in vitro diagnostic medical devices, which will have an impact on all stakeholders in the IVD industry.

BIOMARKER INSIGHTS (2021)

Article Pharmacology & Pharmacy

Evaluation of Current Regulation and Guidelines of Pharmacogenomic Drug Labels: Opportunities for Improvements

Rawan Shekhani et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2020)

Editorial Material Pathology

Implementing the EU in vitro diagnostic regulation - a European regulatory perspective on companion diagnostics

Armin Ritzhaupt et al.

EXPERT REVIEW OF MOLECULAR DIAGNOSTICS (2020)

Editorial Material Pathology

Companion and complementary diagnostics: an important treatment decision tool in precision medicine FOREWORD

Jan Trost Jorgensen

EXPERT REVIEW OF MOLECULAR DIAGNOSTICS (2020)

Review Pharmacology & Pharmacy

DNA mismatch repair in cancer

Marina Baretti et al.

PHARMACOLOGY & THERAPEUTICS (2018)

Review Medicine, Research & Experimental

A Comparison of IHC and FISH Cytogenetic Methods in the Evaluation of HER2 Status in Breast Cancer

Marta Wesola et al.

ADVANCES IN CLINICAL AND EXPERIMENTAL MEDICINE (2015)

Review Medicine, General & Internal

Triple-Negative Breast Cancer

William D. Foulkes et al.

NEW ENGLAND JOURNAL OF MEDICINE (2010)