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Who We Are

Boston Cell Standards (BCS) was founded to bring the modern Quality
techniques of Calibration and Statistical Process Control (SPC) to IHC lab testing.

IHC lab testing is used for diagnosing and treating cancer patients. BCS’ goal is to reduce IHC lab testing error rates from current levels of 10%-30% to <1%. IHC lab testing errors affect cancer patients’ lives.

Watch these two videos to learn how Boston Cell Standards is solving
the IHC lab testing problem

Our Origins

BCS has spent more than 20 years developing new technologies required to bring modern Quality practices to IHC

Our story began in 2003. One of the BCS co-founders, Dr. Steve Bogen, had just sold the Artisan® special stainer (histopathology) product line to Dako Corp. (now Agilent) and returned to academia as Medical Director of the clinical chemistry laboratory, Boston Medical Center. That transition highlighted the contrast in laboratory practice between tissue (histopathology) vs. blood (clinical chemistry) diagnostic testing. Basic quality systems in clinical chemistry, such as reference standards, measurement traceability, units of measure, and Levey-Jennings QC analysis, were unheard-of in immunohistochemistry (histopathology).

The three BCS founders (2015): Steve Bogen, Vani Kodela, Seshi Sompuram
First off-site strategic planning meeting (2021)
The three BCS founders (2015): Steve Bogen, Vani Kodela, Seshi Sompuram
Delivered as off-the-shelf or custom solutions
Can be prepared at many exact and known concentrations
Measurement traceability to NIST reference standard for Fluorescein
Synthetic "cells", Biomarker-coated Microbead.
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Developing the Technology

BCS has spent more than 20 years developing  new technologies required to bring modern Quality practices to IHC. Many of these innovations succeeded only after trial and error. Along the way, the team published many papers and were awarded several U.S. and European patents. The team’s efforts led to a series of innovation firsts.

Leadership Team

Steven Bogen, MD PhD

President & CEO, Co-Founder
Steven Bogen, MD PhD
President & CEO, Co-Founder

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 Medical Director, Clinical Chemistry Laboratory (part-time) at Tufts Medical Center. 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).

Kodela Vani, MS

Vice President and Co-Founder, Manufacturing
Kodela Vani, MS
Vice President and Co-Founder, Manufacturing

Ms. Vani is a co-founder of BCS. She has over 20 years of laboratory experience in biochemistry, molecular biology, and histology. Vani has operational responsibilities for BCS’s cGMP manufacturing processes and document control system in compliance with policies and SOPs. After receiving a Masters degree in Chemistry, she initially worked in Drosophila genetics, gaining experience in the field of molecular biology at Columbia University, New York NY. She later joined the R&D at CytoLogix Corp., Cambridge MA. She is a co-author on numerous peer-reviewed journal articles.

Scott Hofmann-Reardon

Vice President, Commercial Operations
Scott Hofmann-Reardon
Vice President, Commercial Operations

Scott brings 20 years of experience in the immunohistochemistry and molecular diagnostic branches of the Pathology Laboratory. Scott began his career with other members of the Boston Cell Standards team at Cytologix, and then went on to work at Dako and as an original member of the Vision Biosystems North American team, later acquired by Leica (Danaher). Scott has worked for several VC-backed start-up companies in the molecular diagnostics space, and most recently was Global Vice President of Sales, Service, and Field Support at Biocare Medical. Scott received a BS in Chemistry and a BA in English/Journalism from the University of Delaware.

Raisa Loboda

Vice President of Quality
Raisa Loboda
Vice President of Quality

Raisa is a results-driven quality and regulatory leader with over 20 years experience in biotechnology, life sciences, and diagnostics. Her career includes progressive leadership roles at Pacific Biosciences, Bio-Rad Laboratories, Digene, and Applied Biosystems where she implemented compliant, lean methodologies that accelerate product delivery and promote innovation. Raisa has also contributed to advancement of the profession through academia and industry service.  She was an affiliate professor with University of Washington’s Biomedical Regulatory Affairs Master’s Program and served on multiple certification exam committees under the American Society for Quality (ASQ). She earned a BS in Engineering from Miami University and maintains several professional ASQ certifications.

Tomasz Piech

Chief Technology Officer
Tomasz Piech
Chief Technology Officer

Tomasz Piech brings over two decades of experience in software engineering and biotechnology to his role as Chief Technology Officer at Boston Cell Standards. With a background spanning advanced imaging, machine vision, and data analytics, Tomasz has led the design and commercialization of cutting-edge diagnostic devices from concept to market. He has held senior engineering leadership roles at Quanterix and Quantum Diamond Technologies, founded a successful biotech software consultancy, and contributed to numerous peer-reviewed publications in biomedical technology. Tomasz holds a B.S. in Biological Engineering and Computer Science as well as an M.Eng. in Computer Science from Cornell University.

Rob Utzschneider

Chief Business Officer
Rob Utzschneider
Chief Business Officer

Rob brings nearly three decades of experience in a technology start-up involving rapid and significant growth in revenues. He was a co-founder and initial CEO of Torrent Systems, a start-up developing innovative technology for highly scalable data processing. Rob was deeply involved in the business for more than two decades, guiding product direction, technical sales, customer acquisition, and marketing messaging through two acquisitions. During this period, the software evolved into the industry’s leading enterprise data integration platform (IBM Information Server). Revenues generated from this platform grew from $0 initially to more than $20 billion cumulatively during this period. Rob holds an A.B. degree in economics from Dartmouth College and an MBA in finance and marketing from Chicago Booth.

Advisors

Gail Radcliffe, PhD

Regulatory Advisor
Gail Radcliffe, PhD
Regulatory Advisor

Dr. Radcliffe (Radcliffe Consulting, Inc.) has more than 20 years of experience assisting medical device and diagnostics companies with technical assessment, marketing, and clinical/regulatory issues. Gail was awarded her PhD in Molecular Biology from Brown University and completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. Afterward, she worked at GENE-TRAK and then Cytyc, until 1998, when she founded Radcliffe Consulting, Inc. Dr. Radcliffe consults with medical device companies, for market research, regulatory strategy (IVD vs. CLIA lab) and submissions, quality systems development, and clinical trial support. Her experience includes a wide range of products in digital pathology, laser dissection devices, companion diagnostics, and multiplex molecular, POC and CLIA Waived in vitro diagnostic devices.

Melissa Shoemaker

Human Resource Advisor

Board

Joe Gentile

Advisor & Board Member
Joe Gentile
Advisor & Board Member

Mr. Gentile is an operating executive, board member, investor and strategy consultant with over 30 years of experience in medical devices, diagnostics and life science tools. He is currently on the Boards of several start-up companies where he assists in the development of business, commercial, financial and operational strategy. Prior to joining the Board of BCS, Mr. Gentile was CEO and Board member at Cellero Biosciences (acquired by Charles River Labs) and Stemgent Inc (acquired by the ReproCell Group of Japan). Prior to these roles, he spent 14 years at Becton Dickinson (NYSE: BDX) in both corporate strategy and global business unit general management roles. Mr. Gentile began his career in the life sciences at the HP Medical Products Group (now part of Philips Medical Systems) where he spent 10 years in engineering, marketing and corporate development roles for patient monitoring, imaging and diagnostics businesses.

Michael Singer

Advisor & Board Member

Steven Bogen, MD PhD

President & CEO, Co-Founder
Steven Bogen, MD PhD
President & CEO, Co-Founder

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 Medical Director, Clinical Chemistry Laboratory (part-time) at Tufts Medical Center. 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).

Rob Utzschneider

Chief Business Officer
Rob Utzschneider
Chief Business Officer

Rob brings nearly three decades of experience in a technology start-up involving rapid and significant growth in revenues. He was a co-founder and initial CEO of Torrent Systems, a start-up developing innovative technology for highly scalable data processing. Rob was deeply involved in the business for more than two decades, guiding product direction, technical sales, customer acquisition, and marketing messaging through two acquisitions. During this period, the software evolved into the industry’s leading enterprise data integration platform (IBM Information Server). Revenues generated from this platform grew from $0 initially to more than $20 billion cumulatively during this period. Rob holds an A.B. degree in economics from Dartmouth College and an MBA in finance and marketing from Chicago Booth.

Summer 2025 company management outing (L-R): Steve Bogen, Cheng-Tsung Hu, Rob Utzschneider, Raisa Loboda, Vani Kodela, Lauren Styskal, Tomasz Piech, Drorit Bogen, Scott Hofmann-Reardon