Development and Validation of Molecular Assays for Limited Tissue Samples.

Authors:
Robyn Sussman
Robyn Sussman
Children's Hospital of Philadelphia
Jason N Rosenbaum
Jason N Rosenbaum
University of Wisconsin Hospital and Clinics
Madison | United States

Acta Cytol 2019 Apr 17:1-8. Epub 2019 Apr 17.

Center for Personalized Diagnostics, Department of Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA,

As the value of molecular testing of cancer specimens increases, the number of tests imposed on tumor specimens also increases, often in tension with the amount of tumor material available. To develop and validate molecular assays for limited specimens, there are specific concerns that must be addressed, including DNA quality, quantity, and abundance; the number of targets/ability to multiplex; and the analytical sensitivity and specificity of the assay itself. Ultimately, weighing these considerations during assay validation in the overall context of clinical utility and laboratory workflow is critical for delivering the highest level of personalized care to patients.

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Source
https://www.karger.com/Article/FullText/499109
Publisher Site
http://dx.doi.org/10.1159/000499109DOI Listing
April 2019
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