Convergence of Artificial Intelligence (AI), Machine Learning and Proteins Active in the Tumor Microenvironment

OTraces’ founder and CEO Keith Lingenfelter has been an in vitro diagnostic industry innovator and pioneer for many years.  As a senior officer at IGEN International, Inc. in the ‘90s, he developed electrochemiluminesene (ECL) as a diagnostic tool, which was sold to Roche for $1.5 billion in 2003 where it became the nucleus for Roche’ successful ElecsysTM  platform for volume screening platform.

Starting with the founding of OTraces in 2008,  Mr. Lingenfelter has led in the development of OTrace’s core technology which apples the principals of math- and physics-based measure science to in vitro cancer detection and high volume screening for the first time.

Keith Lingenfelter

Founder, Chief Executive Officer and Member of the Board of Directors

  • Former VP and General Manager, Diagnostics for IGEN International where he managed the development of a breakthrough luminescent immunoassay technology for measuring the concentration of proteins and DNA in biological fluids.
  • Licensed to Boehringer Mannheim (now Roche Diagnostics), Eisai Inc., Akzo Pharmaceuticals (Organon Technika) and ABI/Perkin Elmer. These marketing and development partnerships positioned IGEN for an IPO and eventual sale to Roche for $1.5 billion.
  • Prior to IGEN, Mr. Lingenfelter held a number of management positions at Abbott Laboratories where he was primarily involved in strategic marketing and management of large R&D programs that developed chemistry instrumentation and reagents for clinical assays for the in-vitro diagnostic market.
  • Mr. Lingenfelter has a Master’s degree in engineering from California State University.

Alain Cappeluti

Founder, Chief Financial Officer and Chairman of the Board of Directors

  • More than 30 years experience in finance and public accounting for private and public companies, and has participated directly in approximately $4 billion of corporate financing transactions.
  • Management experience in the biotech industry includes BioReliance, Human Genome Sciences (HGS), and CoGenesys. He joined HGS in 1992 at its founding and served for many years as VP of Finance. He was part of the team that spun Cogenesys out from HGS in 2006 and was its’ CFO until it was sold to Teva Pharmaceuticals in 2008.
  • Mr. Cappeluti serves on the OTraces Board of Directors and is currently the company’s largest shareholder. It is the Company’s intention to recruit a full-time CFO in the future as warranted by business activity.

Brian Leyland-Jones M.D. Ph.D.

Chief Medical Officer

  • Dr. Leyland-Jones is the Vice President of Molecular and Experimental Research at the Avera Cancer Institute and the Director of the Darwin Foundation;
  • lead major changes in breast cancer clinical trials and treatments, as well as his ongoing focus on how genomics plays a vital role in the fight against breast cancer;
  • As the Director of the Darwin Foundation (formerly the Consortium for Clinical Diagnostics), Dr. Leyland-Jones is partnering with scientists at research institutions and biopharmaceutical companies who are dedicated to facilitating genomic research and diagnostics.

Richard Saul Ph.D.

Vice President, Research and Product Development

  • In-depth experience in the research, development and technical support of diagnostic products in the areas of clinical chemistry and rapid microbiology.
  • Founder of Axo Diagnostics.
  • Vice President of Product Development at Celsis-Lumac plc
  • Director of Assay Development at IGEN International
  • Director – Chemistry R&D, Dade Stratus, Baxter Diagnostics.
  • Dr. Saul has broad experience in both large and startup organizations, in both the management and hands-on laboratory level, in assay development using various detection technologies, systems development for both unit-dose devices and high throughput instruments, as well as directing the technical and manufacturing support of finished products.

Suzana Radulovich, M.D., PhD

Vice President and CLIA Lab Director

  • MD, PhD. Certified in Clinical Pathology, Immunology.
  • Numerous CLIA Laboratory Licenses.
  • Founded the ALDT Laboratory for 20/20 Gene Systems’ proteomic based Advanced Laboratory Developed Test (ALDT) for lung cancer.
  • Regulatory knowledge and experience (CLIA, COLA, FDA)
  • Broad scientific background in the fields of immunoassays (ELISA); nucleic acids, PCR, qPCR and RT-PCR, isothermal amplification technologies, DNA/RNA sample preparation technologies
  • Institutional services (University of Maryland, School of Medicine) and National services (NIH/NIAID; MIDRP, American College of Physician, CRDF/International Science and Technology reviews)
  • Editorial boards: Infection and Immunity, Journal of Infectious Diseases, Vaccine, FEMS Microbiology, Journal of Immunology, Emerging Infectious Diseases, American Journal of Tropical Medicine & Hygiene, Journal of Immunology, Vector-borne and Zoonotic Diseases, Journal of ASTMH.


Kenneth J. Pienta, M.D.,

  • Donald S. Coffey professor of urology and professor of oncology and pharmacology and molecular sciences at the Johns Hopkins University School of Medicine, and also serves as the director of research at the Brady Urological Institute;
  • widely recognized for his expertise and leadership in prostate cancer research including the development of novel chemotherapeutic programs in prostate cancer;
  • leading authority in translational research and has studied the role of the tumor microenvironment extensively.

Donald Berry Ph.D.

  • Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX
  • Adjunct Professor, Department of Department of Statistics, Rice University, Houston, TX
  • Has championed adaptive trials in clinical research and worked closely with the FDA Center for Devices and Radiological Health to set high scientific and quality standards for a Bayesian approach, which led to adaptive designs gaining favor with both U.S. and international regulatory agencies;
  • Championed the application of Bayesian methods in early cancer detection and the exploration of biomarkers that may signal the onset of tumor formation — especially for non-small cell lung cancer (NSCLC)

Suresh Mohla Ph.D.

  • Dr. Mohla was in the senior ranks of cancer research at the National Cancer Institute for 26 years, specializing primarily in the tumor microenvironment and various aspects thereof including inflammation, stem cells, angiogenesis, lymphangiogenesis, exosomes, metastasis, tumor dormancy and mechanisms of hormone refractory cancers;

Brian Leyland-Jones M.D.

See Biography Above Under Management Team

Company Representative, Richard Saul Ph.D.

See Biography Above Under Management Team


The Hamilton company

Maxim Biomedical

Maxim Biomedical, located in the Rockville, MD, manufactures and supplies reagents and test kits used in the CDx instruments and has extensive global experience serving the needs of a number of leading diagnostics companies. Maxim operates a 30,000 sq. ft. GMP and ISO 13485 certified facility which is equipped to meet OEM manufacturing needs for the pharmaceutical and in vitro diagnostic product industry.

BioIT Solutions

Bio-IT Solutions, based in Maryland, was formed in 2006 to manage the demanding IT requirements of genomic research and bioinformatics for the biotech and pharmaceutical industry. Chief Executive Officer Michael Fannon was formerly the Chief Information Officer of Human Genome Sciences, Inc. from 1994 through September 2005 where he managed the design and implementation of computerized systems to support HGS’s high-volume laboratory data collection, biological research, clinical data management, product development, manufacturing and business operations.

U.S. based Hamilton Company has been a leading manufacturer of medical instrumentation and devices for more than 60 years, with U.S. and branches and subsidiary offices throughout the world. Hamilton manufactures, maintains and services OTraces’ CDX instrument to company specifications.