Regulatory considerations for companion diagnostic devices-Reference-Cited by-同舟云学术

Regulatory considerations for companion diagnostic devices

Published:2015-01 Issue:1 Volume:9 Page:67-75
ISSN:1752-0363
Container-title:Biomarkers in Medicine
language:en
Short-container-title:Biomarkers in Medicine

Author:

Lee Eunice Y¹,Shen Hsin-Chieh Jennifer¹

Affiliation:

1. Division of Molecular Genetics & Pathology, Office of In Vitro Diagnostics & Radiological Health, Center for Devices & Radiological Health, US FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA

Abstract

The emergence of companion diagnostic devices has been spurred by drug discovery and development efforts towards targeted therapies, particularly in oncology. Companion diagnostics and their corresponding therapeutics are often codeveloped, or developed in parallel, to ensure the safe and effective use of the products. The regulatory framework for companion diagnostics has gradually evolved as a result of the essential role of diagnostic tests to identify the intended population for a corresponding treatment. Here, we describe the current regulatory model for companion diagnostics in the US and outline key strategies for a successful codevelopment program from the device perspective. We also discuss how technological advances and changes in clinical management may challenge the regulatory model in the future.

Publisher

Future Medicine Ltd

Subject

Biochemistry, medical,Clinical Biochemistry,Drug Discovery

Link

https://www.futuremedicine.com/doi/pdf/10.2217/bmm.14.98

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