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

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

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).

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