Opportunities and Challenges in Implementation of Multiparameter Single Cell Analysis Platforms for Clinical Translation

Susan M Keating; D Lansing Taylor; Anne L Plant; E David Litwack; Peter Kuhn; Emily J Greenspan; Christopher M Hartshorn; Caroline C Sigman; Gary J Kelloff; David D Chang; Gregory Friberg; Jerry S H Lee; Keisuke Kuida

doi:10.1111/cts.12536

Opportunities and Challenges in Implementation of Multiparameter Single Cell Analysis Platforms for Clinical Translation

Clin Transl Sci. 2018 May;11(3):267-276. doi: 10.1111/cts.12536. Epub 2018 Mar 2.

Authors

Affiliations

¹ CCS Associates, San Jose, California, USA.
² University of Pittsburgh Drug Discovery Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
³ Biosystems and Biomaterials Division Materials Measurement Laboratory, National Institute of Standards and Technology, Gaithersburg, Maryland, USA.
⁴ Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA.
⁵ University of Southern California, Los Angeles, California, USA.
⁶ Center for Strategic Scientific Initiatives, National Cancer Institute, Bethesda, Maryland, USA.
⁷ National Cancer Institute, Bethesda, Maryland, USA.
⁸ Kite Pharma, Inc., Santa Monica, California, USA.
⁹ Amgen, Thousand Oaks, California, USA.
¹⁰ Deciphera Pharmaceuticals, LLC, Waltham, Massachusetts, USA.

Abstract

The high-content interrogation of single cells with platforms optimized for the multiparameter characterization of cells in liquid and solid biopsy samples can enable characterization of heterogeneous populations of cells ex vivo. Doing so will advance the diagnosis, prognosis, and treatment of cancer and other diseases. However, it is important to understand the unique issues in resolving heterogeneity and variability at the single cell level before navigating the validation and regulatory requirements in order for these technologies to impact patient care. Since 2013, leading experts representing industry, academia, and government have been brought together as part of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium to foster the potential of high-content data integration for clinical translation.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Biopsy / methods
Biopsy / standards
Health Plan Implementation / methods*
Health Plan Implementation / organization & administration
Humans
National Institutes of Health (U.S.) / organization & administration
Neoplasms / diagnosis*
Neoplasms / pathology
Prognosis
Single-Cell Analysis / methods*
Single-Cell Analysis / standards
Translational Research, Biomedical / methods*
United States
Validation Studies as Topic