Open Access Highly Accessed Review

Considerations in the development of circulating tumor cell technology for clinical use

David R Parkinson1*, Nicholas Dracopoli2, Brenda Gumbs Petty3, Carolyn Compton4, Massimo Cristofanilli5, Albert Deisseroth6, Daniel F Hayes7, Gordon Kapke8, Prasanna Kumar9, Jerry SH Lee10, Minetta C Liu11, Robert McCormack12, Stanislaw Mikulski13, Larry Nagahara10, Klaus Pantel14, Sonia Pearson-White15, Elizabeth A Punnoose16, Lori T Roadcap17, Andrew E Schade18, Howard I Scher19, Caroline C Sigman3 and Gary J Kelloff10

Author Affiliations

1 New Enterprise Associates, Menlo Park, CA 94025, USA

2 Johnson &Johnson, Radnor, PA, 19087, USA

3 CCS Associates, Mountain View, CA, 94043, USA

4 Critical Path Institute, Tucson, AZ, 85718, USA

5 Fox Chase Cancer Center, Philadelphia, PA, 19111, USA

6 Center for Drug Evaluation Research, US Food & Drug Administration, Silver Spring, MA, 20903, USA

7 University of Michigan, Ann Arbor, MI, 48109, USA

8 Covance Genomic Lab, Covance Central Labs, Seattle, WA, 98382, USA

9 Daiichi-Sankyo Pharma Development, Edison, NJ, 08837, USA

10 National Cancer Institute, Bethesda, MA, 20892, USA

11 Georgetown University, Washington, DC, 20007, USA

12 Veridex, LLC, Raritan, NJ, 08869, USA

13 EMD Serono, Rockland, MA, 02370, USA

14 University Medical Center Hamburg-Eppendorf, 20246, Hamburg, Germany

15 Foundation for the National Institutes of Health, Bethesda, MA, 20814, USA

16 Genentech, South San Francisco, CA, 94080, USA

17 GlaxoSmithKline, Collegeville, PA, 19426, USA

18 Eli Lilly and Company, Indianapolis, IN, 46285, USA

19 Memorial Sloan-Kettering Cancer Center, New York, NY, 10065, USA

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Journal of Translational Medicine 2012, 10:138  doi:10.1186/1479-5876-10-138

Published: 2 July 2012

Abstract

This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI).

Keywords:
Circulating tumor cells; Prognostic biomarker; Predictive biomarker; Analytical validation; Clinical validation; Biomarker qualification; Oncologic drug development