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Review

Companion Diagnostics in Oncology - Current Status and Future Aspects

Jørgensen J.T.

Author affiliations

Dx-Rx Institute, Fredensborg, Denmark

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Oncology 2013;85:59-68

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Article / Publication Details

First-Page Preview
Abstract of Review

Received: January 02, 2013
Accepted: May 21, 2013
Published online: July 10, 2013
Issue release date: July 2013

Number of Print Pages: 10
Number of Figures: 5
Number of Tables: 1

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL

Abstract

A large number of targeted anticancer drugs are currently under development and most of them will have a companion diagnostic linked to their use. If a diagnostic assay is developed in conjunction with a targeted anticancer drug, such an assay will later end up determining the conditions for the use of the drug after its approval. The assay then becomes a kind of ‘gatekeeper' in relation to which patients should be treated with the drug in question. This ‘gatekeeper' role implies that companion diagnostic assays must live up to the same regulatory standards and requirements known from drug development. The assays must have proven to be analytically robust and reliable and to have demonstrated clinical utility before they are routinely used in the clinic. In the drug-diagnostic codevelopment model, several ‘traditional' study designs have been used to demonstrate clinical utility. However, if we are to benefit from the increasing knowledge provided by molecular oncology, new ways should be developed to demonstrate the clinical utility of drug-diagnostic combinations. The development of such an approach will require a rethinking at different levels and is likely to include a number of ethical, regulatory and practical challenges.

© 2013 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Review

Received: January 02, 2013
Accepted: May 21, 2013
Published online: July 10, 2013
Issue release date: July 2013

Number of Print Pages: 10
Number of Figures: 5
Number of Tables: 1

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: http://www.karger.com/OCL


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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