Synbiologica Ltd. is a group of scientists from the University of Lethbridge who are developing a robust, modular sensor called Biologically Enhanced Assay in Real-time (BEAR) used for the highly specific detection of hormones. Current methods of hormone detection are expensive and time consuming. Synbiologica’s device builds upon current detection methods while incorporating new techniques from the emerging biotechnology field of synthetic biology to provide an inexpensive hormone diagnostic device. The ability of BEAR to reduce costs and time for hormone diagnostics will further scientific knowledge and innovation for improved health and ultimately benefiting the research, agricultural and medical communities.

Today, much of the research on how hormone levels affect the behaviour of an individual is done by monitoring the concentration of a particular hormone at specific times and relating it to characteristic behaviours. BEAR is designed to detect hormone concentrations with high accuracy in a fraction of the time taken by conventional detection methods, such as ELISA kits. BEAR will mediate the trade-off between a rapid and accurate test. BEAR is designed to be a modular system, meaning the user will be able to use the system to detect different hormones as they desire.

Synbiologica’s current competition includes companies who produce and sell hormone detection kits and devices that use monoclonal antibodies, as this is the primary method of hormone detection. In 2008, the four-year market projection for both therapeutic and diagnostic monoclonal antibodies was valued at $56 billion. Research-oriented hormone detection kits make up a portion of this market. BEAR is more advantageous to monoclonal antibodies because it will provide a fast, real-time test at a fraction of the cost.

Synbiologica’s initial research and development will begin in research labs at the University of Lethbridge. The company plans to use resources at the University, such as the Technology Transfer Office and the Industry Liaison Office to assist the company in market analysis, funding acquirement, and patenting.

The target markets for the device include hormone researchers, the livestock agriculture industry, and medical diagnosticians. These parties are handicapped by long and costly sample analysis periods. The time it takes to test a sample for a hormone can range from many hours to days. This also poses the risk of the hormone degrading in the sample, which can lead to inaccurate results. BEAR will allow hormone researchers and diagnosticians to observe hormonal fluctuations in real-time, yielding a more detailed result that will provide a greater understanding of the hormone in question. Those working in the livestock industry will be able to quickly and safely test animals for pregnancy, growth hormones and hormones related to disease. The opportunities this new test will provide will be far-reaching, leading to the development of innovative health care practices that will enhance diagnostics and treatment of disease.

In a 2008 report, the market for both therapeutic and diagnostic monoclonal antibodies was valued at $56 billion for 2012, representing a compound annual growth rate of 13%.1 The global market for the therapeutic monoclonal antibody industry in 2011 was estimated at $44.6 billion annually.2 This has nearly doubled from 2006 when the global market was estimated at $19 billion with $7.2 billion for immunoassays, and $3.1 billion in clinical diagnostics.3 The Canadian medical device market was estimated at $6.4 billion annually in 2008.4 The biotechnology market is also forecast to have a value of $4.6 billion by 2012, demonstrating an increase of 39.4% since 2011.5

The business model Synbiologica is pursuing is to license out the patented technology to larger established biotechnology or medical device companies with the resources to build, market and distribute the product.

For added market value, initial prototypes will be further utilized by scientific researchers to gain greater medical diagnostic value. Synbiologica assumes that our product will reveal new behavioural aspects and lifesaving hormone diagnostics in the industry that were not previously known because it will allow researchers to quantify changes in hormone levels as they are occurring. This will add further value to the product and increase its appeal for application in medical diagnostics, resulting in further commercialization beyond the research world. Investors will have an opportunity to be part of a revolutionary, potentially lifesaving biotechnological development.

The major milestones Synbiologica Ltd. will achieve in upcoming years include acquiring an Alberta Innovation Voucher for the amount of $15,000 to have an Opportunity Assessment Report conducted. The Alberta Innovates Technology Futures Voucher Program is designed to help small early stage technology businesses operating in Alberta to be successful in a global market place. This program provides a third-party opportunity assessment fund, with which the value of our prototype will be determined in relative markets. Additional voucher support programs though Alberta Innovates will be pursued. Synbiologica then plans to acquire the support of early investors for $500 000 and industry knowledge support for further prototype development and initial market entry. By the 5th year, Synbiologica will seek a second round of investment of $20-30 million for clinical testing and FDA approval for up-scaling production. At this point Synbiologica anticipates that the impact of the technology will be recognised by larger biotechnology and medical device companies, to whom we plan to license-out and eventually sell BEAR technology. Synbiologica would then move on to new projects.

Management of the company will be the responsibility of the members of the Lethbridge Entrepreneurial iGEM team (2013):

Team

• Isaac Ward, Chief Executive Officer – Undergraduate Student Bachelor of Science Majoring in Neuroscience
• Erin Kelly, Chief Operating Officer - Undergraduate Student Bachelor of Science Majoring in Biochemistry
• Mackenzie Coatham, Chief Science Officer/ Biotechnologist - Masters Student in Biochemistry (BSc 2012)
• Harland Brandon, Chief Science Officer / Biotechnologist - Masters Student in Biochemistry (BSc 2013)

Advisors:

• Dr. Gerlinde Metz, Professor of Neuroscience, Canadian Centre for Behavioural Neuroscience, University of Lethbridge and Alberta Heritage Foundation for Medical Research Senior Scholar
• Dr. H.J. Wieden, Associate Professor of Biochemistry, Department of Chemistry and Biochemistry, University of Lethbridge
• Michael Kelly, Lethbridge Land-Manager, Real Estate and Land Development
• Dr. Roy Goldsteyn, Associate Professor of Biology, Department of Biology, University of Lethbridge and Alberta Ingenuity Faculty member, Economic Development Lethbridge Board Member for Technology and Research