Abstract B64: Translating the ClarityDxProstate microflow cytometry extracellular vesicle assay to the clinic: A real-world experience in progress
Authors: Pink Desmond , Paproski Robert , Vasquez Catalina , Wong Michael , Pham Diana , Pillai Renjith , Hiebert Rebecca , Stifanyk Leanne , Koch Sylvia , Lewis John 
Published: June 2020

Abstract
Nanostics, in partnership with a major Canadian medical laboratory, DynaLIFE, is translating the microflow assay ClarityDX Prostate designed for identification of aggressive prostate cancer, to the clinic. Building upon a previous prospective analysis using frozen samples, we are validating our test in fresh blood samples from a cohort of 2,800 men suspected of prostate cancer. Our current data provide insight into some of the logistical issues and realities of translating a liquid biopsy, extracellular vesicle (EV) microflow cytometry test to an effective clinical workflow. To ensure the highest rigor, translating our EV test to a clinical microflow pathway has involved discussions with regulatory consultants, statisticians, clinical flow cytometry operators, feasibility experts, clinical coordinators, and physicians. Initial engagement with physicians early in the process affirmed the clinical unmet need and that it is great to have a new test, but it must have the potential to significantly improve clinical outcomes. The regulatory consultants and statisticians provided a reality check as to the amount of testing that needs to be conducted to translate a test to the clinic. Since the clinical lab and the academic lab workflows are very different, discussions with clinical flow cytometry operators provided an unbiased assessment of how our SOPs and workflow would translate. Keeping a test as streamlined as possible improves overall feasibility because each additional step adds time, complexity, variability, and cost. Clinical coordinators navigate ethics to streamline SOPs for patient consultation and sample collection. The SOPs for sample collection, shipping, and processing have been written and validated so that each procedural step could be performed by test-naive operators following a brief training period. Preanalytical validation established the assay conditions and workflow. These preanalytics are now being validated under current conditions according to CLSI guidelines. These include interfering substances, LOD, reproducibility, etc. We have developed in-house positive and negative controls for 5 biomarkers that have shown &gt;3-month stability. Adapting our test to a valid clinical workflow is a significant and challenging undertaking. In this discussion, we outline our experiences as we translate the ClarityDxProstate test from the bench to a real-world clinical workflow.
Citation Format: Desmond Pink, Robert Paproski, Catalina Vasquez, Michael Wong, Diana Pham, Renjith Pillai, Rebecca Hiebert, Leanne Stifanyk, Sylvia Koch, John Lewis. Translating the ClarityDxProstate microflow cytometry extracellular vesicle assay to the clinic: A real-world experience in progress [abstract]. In: Proceedings of the AACR Special Conference on Advances in Liquid Biopsies; Jan 13-16, 2020; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(11_Suppl):Abstract nr B64.