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Liquid Biopsies in Oncology and the Current Regulatory Landscape

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Abstract

There is a profound need in oncology to detect cancer earlier, guide individualized therapies, and better monitor progress during treatment. Currently, some of this information can be achieved through solid tissue biopsy and imaging. However, these techniques are limited because of the invasiveness of the procedure and the size of the tumor. A liquid biopsy can overcome these barriers as its non-invasive nature allows samples to be collected over time. Liquid biopsies may also allow earlier detection than traditional imaging. Liquid biopsies include the analysis of circulating tumor cells (CTCs), cell-free nucleic acid (cfNA), or extracellular vesicles obtained from a variety of biofluids, such as peripheral blood. In this review, we discuss different liquid biopsy types and how they fit into the current regulatory landscape.

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Acknowledgments

LS, LM and ML contributed to the writing of the manuscript. LS created the figure. ML and RV served as editors for the manuscript.

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Authors and Affiliations

  1. Department of Pathology and Laboratory Medicine, School of Medicine, University of Louisville, 511 South Floyd Street, MDR 221, Louisville, KY, 40202, USA

    Lindsay N. Strotman, Lori M. Millner, Roland Valdes Jr. & Mark W. Linder

  2. PGXL Technologies, 201 E. Floyd St., Suite 306, Louisville, KY, USA

    Lindsay N. Strotman, Lori M. Millner, Roland Valdes Jr. & Mark W. Linder

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  1. Lindsay N. Strotman
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  2. Lori M. Millner
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Correspondence to Mark W. Linder.

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LS, LM, ML, and RV declare no conflicts of interest.

Funding

This work was funded by the National Institute of Health Grant # HHSN261201500035C and HHSN261201300034C.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Strotman, L.N., Millner, L.M., Valdes, R. et al. Liquid Biopsies in Oncology and the Current Regulatory Landscape. Mol Diagn Ther 20, 429–436 (2016). https://doi.org/10.1007/s40291-016-0220-5

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