Abstract
Translational research teams depending on an immunohistochemical (IHC) assay for patient treatment stratification lack 2 essential tools: (a) an adjustable assay cutpoint that facilitates optimal separation of patient treatment groups based on analyte expression, and (b) the ability to lock in that expression level cutpoint once the clinical trial demonstrates efficacy. Presently, IHC clinical trial assays rely solely on image-based cutpoints, which are subject to a floating cutpoint error; the image depends on the analytic sensitivity of the IHC assay. Funded by the National Cancer Institute, Boston Cell Standards (BCS) created the first cellular calibrators that can be mass produced with exact analyte concentrations. Cellular calibrators deliver an actionable unit of measure to IHC companion diagnostic testing, traceable to a NIST standard. In this webinar, Steven Bogen, MD, PhD, will
- Describe the technology and factors for successful creation of custom IHC calibration standards
- Review published examples of IHC calibrators and how they affect FDA-cleared CDx assays
- Explain the use of calibrators in standardizing from one instrument to the next and across kit lots.
Dr. Bogen will also describe several federally funded objectives BCS has been involved with and provide examples of translational research applications.
Speaker: Dr. Steven Bogen
CEO of Boston Cell Standards
Dr. Bogen is a Board-Certified Clinical Pathologist, having graduated from the University of Chicago Pritzker School of Medicine (M.D.) and the Weizman Institute of Science (Ph.D.), with a post-graduate residency and research fellowship at the Brigham and Women’s Hospital. He is Adjunct Professor of Pathology and Laboratory Medicine at Tufts University School of Medicine and served as Medical Director, Clinical Chemistry Laboratory at Tufts Medical Center until 2021. Dr. Bogen is an inventor on 22 patents, all of which relate to various medical diagnostic technologies. In addition, he served for a decade on several NIH grant review committees, mainly for the Innovative Molecular Analysis of Cancer Technologies program sponsored by the National Cancer Institute. Dr. Bogen was previously the founder of CytoLogix Corporation, which developed the Artisan® instrument system for automated complex histopathology stains (now sold and supported by Agilent Corporation).
