In the fall of 2001, the United States was in the throes of an anthrax infection mystery, which has never been resolved. By December 5, 2001, 22 cases of anthrax exposure had been reported by the Center for Disease Control, with five of those cases ending in death. With no on-site test method available, samples were returned to a lab for analysis, where hours or days could pass before results were announced. This was not good enough - Americans were in a panic and the need for a quick anthrax test kit for police, paramedics and other First Responders became a top priority.
Enter 20/20 Gene Systems President and CEO, Jonathan Cohen. During the fall of 2001, Cohen, a former paramedic and volunteer fire fighter, contacted then-Deputy Fire Chief Theodore Jarboe (Montgomery County Maryland) to ask how he could help. As it turned out, 20/20 Gene Systems, out of Rockville, Maryland, was in a good position to help. The biotech company's core platform, layered membrane technology, could be used to identify certain proteins that make up anthrax and other powder-form bio-threats.
At the time, there was no portable, easy-to-use test kit that could determine anthrax or any other type of protein-based toxin, but the need for such a kit, according to Chief Jarboe, was immediate and urgent. Within six weeks, the 20/20 Gene Systems engineered BioCheck™, a portable, quick-acting bio-hazard detection kit.
During almost all of 2002, 20/20 Gene Systems offered the kits to First Responders at no charge as a Beta test in exchange for their feedback. One of the first Beta test customers was the Washington, DC Fire and EMS departments. Then-Battalion Chief, Michael Sellitto immediately saw the convenience and prompt results delivered by the kit and he worked out a deal with 20/20 Gene Systems, where the department agreed to provide the company with data on the results of use during actual emergency calls. Using this information to engineer BioCheck's enhancements, 20/20 Gene System's first fully functioning bio-hazard detection kit was ready for market and rolled out in January, 2003.
BioCheck was an immediate success due to the fact that the product was simple to use, required no instrumentation and provided accurate results within minutes. The kit consists of a small box which contains of a tray containing two test tubes and two wetted swabs. One test tube is labeled "Protein" and the other labeled "pH". A sample is collected on the swabs then each swab is immersed in the test tubes which contain a solution. The solution in the protein detection tube may turn purple after five minutes, but only if protein is present. The solution remains colorless in the absence of protein. The results of the pH test helps First Responders more accurately determine the chemical properties of the substance being tested.
While BioCheck was a clear cut above taking samples to a lab then waiting hours for the results, the kit still needed some necessary improvements. In mid-2004, 20/20 Gene Systems submitted an application for CCAT funding and business services. In October of 2004, the company was informed that they had been granted $75,000 in product development funding, as well as a market study which was completed and that was completed in April 2005.
The company used the CCAT funds to alter the chemical make-up of the solutions in February 2005 so that their sensitivity level increased almost 10 fold to 12 μg. They were also able to develop a training module using the CCAT funds, which has been extremely successful. The training consists of a binder containing detailed product information and a PowerPoint presentation providing step-by-step usage information and a test kit. In addition to providing users with an economical practice kit, the module also saves training costs, since there is no instructor or travel time required.
When the CCAT market study showed that there was also a need for the kit in private industry and the company has begun pursuing this market with some initial success. Several Fortune 500 organizations concluded that the BioCheck kit can test suspicious powders quickly and on-the-spot, thus reducing the risk of a potentially embarrassing public relations incident involving a siren-wailing emergency call. While the private sector still remains a distant second to emergency crews in terms of usage, this market continues to grow steadily.
Since working with CCAT, 20/20 Gene Systems' inclusion of private industry sales and the product upgrades have had an immediate effect on revenues resulting in an over 40 percent increase. But the company is not about to rest on its laurels - bio-terrorism threats are common and 20/20 Gene Systems is exploring innovative technologies to combat the threats.
For more information, please contact:
Tom Sheffer, CCAT Program Director
SDSU Research Foundation
E-mail: tsheffer@foundation.sdsu.edu
Phone: (619) 594-4135 / Fax: (619) 594-5774