Thursday, December 13, 2012

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

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).

click here for the full article

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