Company

Predictive power is one of the most challenging performance metrics in in vitro diagnostics that takes false signals into full account. A high level of predictive power is seen as essential for successful global deployment of any high-volume cancer screening test, both economically and from a regulatory approval standpoint. OTraces is the only company that currently excels by this standard, and has significant patent filings in place.
Ability to use the tumor microenvironment (TME) for cancer diagnosis as we have experienced in our breast and prostate cancer validation trials to date may be our largest accomplishment. The value of this capability is only now starting to gain recognition.
The advantages of using the TME as compared with DNA-based liquid biopsy include determination of whether cancer is present or not; differentiation between aggressive and quiescent tumors; and accurate determination of cancer stage as well as rate of tumor progression.

One of the top priorities in cancer research is for a simple blood test for accurate detection. Even today’s most advanced proteomic and DNA-based tests have predictive power of no more than 80-85% — not regarded a high enough for the rigors of global deployment. Despite progress in liquid biopsy and genetic profiling, these methods are not meant for or being used for detection.

 

  • OTraces believes that proteomic complexity imposes restrictions on test accuracy that conventional chemistry-based tests cannot resolve.
  • OTraces is the first company to use math- and physics-based measurement science and noise-suppression techniques commonly used in other fields like space communications, and adapted them to the unique challenges of disease detection with remarkable results.
  • In recent tests including validation trials now underway for the company’s blood tests for breast and prostate cancer, OTraces has consistently achieved 95%-plus predictive power.

HISTORY

Convergence of Mathematics and Biology

OTraces was founded in 2008 by CEO Keith Lingenfelter, a leading expert in in vitro diagnostics with extensive Abbott Laboratories and IGEN International, Inc. experience. OTraces was founded to capitalize on emerging trends in proteomics based disease detection technology and on market opportunities including the following:

  • to improve the accuracy of disease detection testing by applying OTraces’ unique math- and physics-based computational techniques.
  • to provide a long-overdue breakthrough in blood-based cancer screening tests, wherein the only significant approved product has been the Prostate Specific Antigen (PSA) assay which was cleared by the U.S. FDA in 1986.
  • to address global market of healthy adults presently not being tested for cancer as part of their routine annual physical exams for lack of an affordable and accurate screening test, — a market substantially larger than the current cancer therapeutics field.

Management

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 Member 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.

J. Michael Hamilton, M.D.

Chief Medical Officer

  • Oncologist and physician-scientist with more than 30 years of experience developing cancer drugs.
  • Managed corporate drug development efforts at Avalon Pharmaceuticals as Chief Medical Officer.
  • Developed innovative programs for translational use of biomarkers in pre-clinical and clinical studies.
  • Pioneered FDA-approved clinical trial that used multivariate biomarker sets for personalized drug response.
  • Lead the successful late stage development of Bexxar® at GlaxoSmithKline.
  • At the National Cancer Institute (NCI), supervised clinical strategy in colorectal cancer and CNS tumors.
  • Served as chairman of the NCI Institutional Review Board.

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.

John W. Pettit Ph.D.

Vice President Bioinformatics

  • More than 30 years of experience as a high technology entrepreneur. Founded, grew and exited from several high technology ventures with emphasis on embedded computing, signal analysis, real time data processing and applied statistics.
  • Founder of iDNA Technologies Developing next generation DNA analysis technology and wearable medical devices utilizing low power wireless technology, nanomaterials based detection, statistical methods for prediction and cloud computing.
  • Founder and CEO of MicroLab Diagnostics Developed in partnership with Lockheed-Martin the first totally integrated real time, on demand DNA analysis system that was used in forensics and law enforcement applications. Sold MicroLab for a profit in 2010.
  • Director of Engineering for the Instrumentation Division of Bethesda Research Laboratories which later became Invitrogen Developed the industry’s first semi-automated DNA analyzer with software algorithms to perform DNA sequencing, fragment size analysis and restriction enzyme digest analysis
  • Invited Speaker at NIST and IEEE
  • Over 20 Issued Patents
  • Author of key technical research papers in peer reviewed journals
  • Ph.D. in Engineering Physics from Rensselaer Polytechnic Institute

Mohsen Marefat

Vice President, International Business Development and Sales

  • VP Operations at Bio-IT Solutions
  • Managing Director of Global Operations at The Althing Group.
  • President of the International Drug Discovery Institute aimed at defeating neglected diseases.
  • R&D work at IBM’s Information Product Testing Division.
  • Over the past two decades, he has helped manage companies engaged in Software, Telecom, and Life Sciences innovations.
  • Mr. Marefat’s brought in the Russian Distribution Partnership with Bitubo.

Additional Management

The Company has been operating with a group of long time business associates who are acting in a consulting capacity, performing functions such as engineering, software development, immunoassay development, clinical laboratory product development, regulatory affairs coordination, business development, patent consultation and manufacturing operations. All of these people have worked with Mr. Lingenfelter in the past on successful endeavors and are highly experienced. The CRO consultants have already connected with the Canadian Regulatory Apparatus and have completed plans for clinical trials. All of these people would be qualified to serve as OTraces employees if financial circumstances permit.

The Hamilton company

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.

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.