Development of a reliable assay to measure glypican-1 in plasma and serum reveals circulating glypican-1 as a novel prostate cancer biomarker

// Rachel A. Levin 1 , Maria E. Lund 1 , Quach Truong 1 , Angela Wu 1 , Neal D. Shore 2 , Daniel R. Saltzstein 2 , Raoul S. Concepcion 2 , Thomas A. Paivanas 2 , Arletta van Breda 2 , Jennifer Beebe-Dimmer 3 , Julie J. Ruterbusch 3 , Sandra Wissmueller 1 , Douglas H. Campbell 1 and Bradley J. Walsh 1 1 Minomic International Ltd, Sydney, New South Wales, Australia 2 CUSP LLC Research Consortium, Annandale, VA, USA 3 Barbara Ann Karmanos Cancer Institute and Wayne State University, School of Medicine, Department of Oncology, Detroit, MI, USA Correspondence to: Bradley J. Walsh, email: brad.walsh@minomic.com Keywords: prostate cancer; biomarker; glypican-1; MIL-38; 3G5 Received: October 07, 2017      Accepted: March 11, 2018      Published: ABSTRACT Prostate cancer is responsible for hundreds of thousands of annual deaths worldwide. The current gold standard in early detection of prostate cancer, the prostate specific antigen test, boasts a high sensitivity but low specificity, resulting in many unnecessary prostate biopsies. Thus, emphasis has been placed on identifying new biomarkers to improve prostate cancer detection. Glypican-1 has recently been proposed as one such biomarker, however further exploration into its predictive power has been hindered by a lack of available, dependable glypican-1 immunoassays. Previously, we identified human glypican-1 as the antigenic target of the MIL-38 monoclonal antibody. Additionally, we have now generated another monoclonal antibody, 3G5, that also recognizes human glypican-1. Here we report the development of a reliable, custom Luminex ® assay that enables precise quantitation of circulating human glypican-1 in plasma and serum. Using this assay, we show for the first time that circulating glypican-1 levels can differentiate non-cancer (normal and benign prostatic hyperplasia) patients from prostate cancer patients, as well as benign prostatic hyperplasia patients alone from prostate cancer patients. Our findings strongly promote future investigation into the use of glypican-1 for early detection of prostate cancer.