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Diffinity Genomics

1. What is Diffinity Genomics?

In Rochester, NY, a biotechnology company named Diffinity Genomics has developed technology for purifying nucleic acids via a quick and easy method. This technology can be placed inside a pipette tip, allowing the user to simply aspirate the solution containing the DNA and then mix the solution by pipetting for approximately one minute while the impurities to be removed bind to the DiffinityTM technology inside. The tip then dispenses purified DNA ready for further analysis. There are many uses for the resulting solution – sequencing, cloning, in vitro transcription, to name a few. Purification of DNA is necessary for effective analysis, since failure to remove impurities often interferes with the analysis and can lead to inaccurate results.

Diffinity Genomic’s technology works by configuring surfaces to selectively adsorb certain kinds of nucleic acids (‘adsorption’ is the adhesion of gas, liquid or dissolved solid molecules to a surface) while simultaneously repelling other types of nucleic acids. Surfaces that provide for molecular adhesion can be implemented in many forms, including the inside of a disposable pipette tip. Their technology is of primary interest to the DNA purification and molecular diagnostic markets. The non-regulated scientific uses for this product include removing impurities from DNA (or RNA) mixtures and enabling further analysis, such as locating the presence of certain genetic characteristics. Molecular diagnostic applications can be found in human, animal and plant applications related to diagnostics (i.e., confirming the presence of diseases); therapeutic settings where there is a need for assessing a patient’s response to therapy; prognostics for the purpose of predicting and pre-treating future conditions; and pharmacogenetics where it may be needed for selecting the proper form of therapy for a patient.

2. How was Diffinity Genomics created? What relationships and collaborative efforts were involved in bringing the technology to market?

The technology was developed in collaboration with researchers at the University of Rochester. Diffinity Genomics has exclusive rights to commercialize the technology into products for the rapidly growing Life Science markets. Founded in 2005, the company was awarded $105,504 from the National Center for Research Resources (NCRR) to assist in its efforts to commercialize the technology. This Phase I STTR Grant was provided to develop the fundamental nucleic acid adsorption technology. In 2008, Diffinity Genomics was awarded a Phase II STTR grant of $717,229 by the same organization to help commercialize the first application of the company's technology – the RapidTip for PCR Purification. These funds facilitated the development of the single-use, Diffinity RapidTip™ pipette tip, including product manufacturing scale-up and market launch. Angel funding from investors in Buffalo, Rochester and Syracuse have also provided significant operating capital. High Tech Rochester (an organization that helps incubators and startups) and local businesses have also helped develop the business and commercialize the company’s first product.

3. Would you briefly describe Diffinity Genomics’ business plan?

Diffinity Genomics initially plans to develop and manufacture non-regulated nucleic acid purification products and sell directly into the market. The users of DNA purification products include research scientists and technicians working in hospitals, biotechnology companies, clinical laboratories, government agencies, agricultural companies, pharmaceutical companies, forensic laboratories, academic institutions and medical schools. Once key sales targets are met, the company intends to provide exclusive product marketing, distribution, and sales rights to large, established suppliers to the industry. The company plans to license molecular diagnostic applications of its technology to well-established companies for application in their products.

4. What is the current status of Diffinity Genomics?

Over the next couple months, the company will be releasing the Diffinity RapidTip™ for sale, which allows the user to purify PCR product in a single, one-minute step. The equipment required is minimal, as the user only needs a standard pipettor and a Diffinity RapidTip pipette tip. We have had excellent feedback from our beta testers who have used the RapidTip, and we have a high level of interest from numerous academic and research institutions that wish to use the product. We are looking forward to a very successful launch! In addition, we have already redirected our scientists and engineers to work on follow-on products – so look for new and exciting products from us in the near future.

5. Who is on the Diffinity Genomics team?

• Jeff Helfer, CEO
• Dr. Lewis J. Rothberg, CTO
• Robin Hodownes, VP Sales & Marketing
• Rhiannon Gaborski, Research & Development Program Manager
• Maurice A. Kildal, Chief of Operations
• Barbara Stwertka, Senior Research Scientist
• William Begley, Senior Research Scientist
• Tom Jenssen, Director of Manufacturing
• Diane Socciarelli, Production Technician
• Rachel Rattner, Research Assistant

6. How was Diffinity Genomics named?

Great question! The company was formed as the result of a Pre-Seed Workshop jointly sponsored by High Tech Rochester and the University of Rochester. The company’s objective has been to commercialize novel nucleic acid adsorption technology developed by Dr. Lewis J. Rothberg and his collaborators. The word ‘diffinity’ is actually a contraction for this ‘differential’ (adsorption) ‘affinity’ – a core principle of how our technology works.