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Review
. 2018 Jun;103(6):999-1008.
doi: 10.1002/cpt.955. Epub 2017 Dec 20.

Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology

Jan Trøst Jørgensen  1 , Maria Hersom  2
Affiliations
Review

Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology

Jan Trøst Jørgensen et al. Clin Pharmacol Ther. 2018 Jun.

Abstract

Nearly 20 years have passed since the US Food and Drug Administration (FDA) approved the first companion diagnostic and today this type of assay governs the use of 21 different anticancer drugs. The regulators deem these assays essential for the safe and effective use of a corresponding therapeutic product. The companion diagnostic assays are important both during the drug development process as well as essential treatment decision tools after the approval of the drugs.

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