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(From the fall 2005 Proof of Concept investment (POCi) proposal by CLP MicroTechnologies)

Development of an ante mortem diagnostic test for Mad Cow disease

Christopher N. Bowman, Dept. of Chemical and Biological Engineering

Kristi S. Anseth, Dept. of Chemical and Biological Engineering

Robert H. Davis, Dept. of Chemical and Biological Engineering

Brian T. Good, CLP MicroTechnologies, Inc.

Project Summary

All of us remember the Mad Cow disease scare in Europe a few years ago. In the U.S., that memory resurfaced with the discovery of cattle testing positive for Mad Cow disease. This has ignited fears about the safety of U.S. beef and created concern about the crippling effect another Mad Cow scare would have on the U.S. beef industry. These limited cases have resulted in a number of foreign countries banning U.S. beef imports. One example is Japan, who accounted for almost 40% of U.S. beef exports before the Mad Cow scare [1, 2]. As a result, U.S. beef prices have dropped and have had a dramatic impact on the $50 billion U.S. beef industry [1].

Part of the fear with Mad Cow disease, scientifically known as bovine spongiform encephalopathy (BSE), is that it is not well understood. Scientists do know that BSE is a devastating neurodegenerative disease in cattle caused by misfolded prion proteins that create holes in the brain of the host. Other prion-related diseases include scrapie in sheep and goats, chronic wasting disease in deer and elk, and Creutzfeldt-Jakob disease in humans. These diseases are difficult to detect because the infectious agents are present at very low concentration levels.

In fact, there is no diagnostic test sensitive enough to determine if live cattle have the infectious agents that cause BSE. The only reliable test is by post-mortem examination of brain tissue where infectious agents are at a level that can be detected using current enzyme-linked immunosorbent assay (ELISA) tests. However, given the time required to perform the test, potentially other infected cattle have been slaughtered and entered the food supply prompting a recall and inciting public fear of beef. If humans eat the tainted beef, they may become infected with a form of Creutzfeldt-Jakob disease, which has no cure [3].

We will develop a BSE diagnostic device for live cattle by combining three technologies invented and developed at the University of Colorado. Thesepatented technologies are:

  • On Chip Signal Amplification by Photopolymerization,
  • Fabrication of 3D Photopolymeric Devices,
  • Detection of Molecular Recognition on a Surface-Passivated Microfluidic Device.

CLP MicroTechnologies (CLP) has access to two of these patents through our strategic partners and the third patent is available for use through the University of Colorado’s Technology Transfer Office. In combination, this disruptive technology will provide an early detection system to enable on-site testing of cattle with rapid, unambiguous results. The finished device will enable a veterinarian (or cattle rancher) to simply add the blood sample into the device and observe the results.

An estimated 200,000 to 300,000 U.S. cattle will be tested in 2005. This number is trending upwards as stricter government regulations are enacted to alleviate domestic and international concern over the U.S. beef supply. For example, Japan is requesting that all U.S. cattle be tested for BSE. Therefore, the need exists for an easy-to-use, rapid diagnostic test for the 35 million cattle that are slaughtered each year in the U.S. and 110 million worldwide. In addition, with the ability to test live cattle for BSE, infected cattle can be removed without contamination concerns.

The United States Dept. of Agriculture, National Institute of Health, and the Dept. of Defense have identified prion-related diseases as current concerns as evidenced by recent requests for proposals. We expect our live cattle diagnostic test for BSE (~$10/device) to be cheaper than current post-mortem ELISA tests (greater than $15/device), with the added benefits of early, rapid detection, portability and ease of use.

It is important to note that the detection system presented in this proposal is a universal platform. Our detection system can be adapted for other infection diseases, such as avian flu and cancer, as well as the detection of biological warfare agents. Once the BSE detection device is commercialized, CLP will investigate other potential applications.