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Harry Rittenhouse, Amy Blase, Blair Shamel, Jack Schalken, Jack Groskopf, The Long and Winding Road to FDA Approval of a Novel Prostate Cancer Test: Our Story, Clinical Chemistry, Volume 59, Issue 1, 1 January 2013, Pages 32–34, https://doi.org/10.1373/clinchem.2012.198739
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Only a very small fraction of the many tumor biomarkers discovered are successfully translated from the academic research laboratory into clinical practice. The pathway has not always been linear and has involved people with expertise in a wide range of specialties, including basic research, assay development, clinical affairs, regulatory affairs, marketing, business, oncology, and executive-management leadership. The experience with a tumor biomarker, the PCA3 [prostate cancer gene 3 (non-protein coding)] gene, illustrates the long and winding road that must be navigated. Here we reflect, from a historical point of view, on how the interface between academic science, industry, urologists, and clinical laboratories has been essential to advance biomarkers from solid basic science to a validated clinical laboratory test.
PCA3 was first described as DD3 in 1999 by Bussemakers and colleagues (1). Researchers in the Isaacs laboratory at Johns Hopkins University used differential-display analysis to compare patterns of mRNA production in benign and malignant prostate tissue, with the goal of identifying unknown genes involved in prostate tumorigenesis. PCA3 expression was further characterized in the Schalken laboratory at Radboud University, Nijmegen (2), and this research confirmed 2 important properties of PCA3 as a prostate cancer (PCa)6 marker: PCA3 expression is prostate tissue specific, and PCA3 is highly overexpressed in PCa compared with benign tissue. This PCa-specific overexpression led the Nijmegen researchers to assess the feasibility of a PCA3-based urine test for PCa detection.
