Personalized Medicine: Validation of Diagnostic Medical Devices

Authored by: Meijuan Li , Gene Pennello , Jincao Wu , Laura Yee , Zhiwei Zhang , Gerry Gray , Yuying Jin , Yaji Xu , Jingjing Ye , Zhiheng Xu

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:

10.1201/9781351110273-140000050

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Abstract

This entry provides general considerations for the validation of diagnostic medical devices whose results have direct or indirect potential to “personalize” patient care. In particular, the clinical validation of companion diagnostic devices and corresponding therapeutic products, risk prediction devices, and monitoring devices are discussed. In addition, the often neglected topic of analytically validating the biomarker measurement(s) made by a diagnostic device, including measurement accuracy and reproducibility is discussed.

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