A Wright Grant from Ohio’s Third Frontier business development program  has permitted the creation of a ‘state-of-the-art’, secure manufacturing facility in Kent State University’s Centennial Research Park. The plant’s high-tech equipment is capable of producing about one million cassettes per year under highly controlled conditions. The company estimates that the cost to produce a fully loaded cassette with antibodies, liquid crystals and all other materials except the sample to be tested, will be ≤$10.00.

Food Market Parameters

The domestic market for pathogen detection in food is already large, totaling $3.029 billion in 2010. The market is predicted to grow about 6.6% annually to reach about $4.2 billion by 2015. Almost 65% of this market – or more than $1.9 billion - involves testing meat, poultry and produce, the commodities where the company is focusing.

A variety of solid reasons support the projection: centralized agriculture and increasingly broad distribution substantially increase risk for the public and for the companies themselves; globalization of the food supply vastly increases risk and the need for testing; both USDA and FDA, have  the authority and stated intent to require increased testing for pathogens; the direct and related (for example, health care) costs of food contamination, for companies and the economy, are better recognized and reported; the population is aging and therefore more vulnerable to food-borne pathogens.

For perspective, FSIS (USDA) is responsible for testing meat. It appears that no more than about 110,000 tests are required and performed in FSIS laboratories. This equates to roughly one test per 300 head of cattle. The FDA, responsible for foods other than meat, does not require any testing of produce, though it “spot checks” about 1000 samples/year using its own funds from the Microbiological Testing Program.

Significant levels of voluntary testing are being conducted by the individual companies in the attempt to protect their customers and shield themselves from financial and reputational loss.  End users suggest that testing is increasingly important. Accurate testing permits a reduction in inventory, storage and other costs.  An ideal test will detect multiple pathogens in a single assay to shorten time and lessen the need for personnel, space and equipment.  Additionally, the ideal test would be simple to use so that technicians rather than highly educated and trained specialists can do the testing. CDx’s technology ideally meets these needs.