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College Park-Based Innovative Biosensors Closing in on Diagnostic Test for Mad Cow Disease

Posted on: Monday, 8 August 2005, 21:00 CDT

A newly awarded federal grant is helping College Park-based Innovative Biosensors Inc. develop a faster and more sensitive diagnostic test for bovine spongiform encephalopathy, or mad cow disease.

The 2-year-old firm, a resident of the University of Maryland, College Park's Technology Advancement Program incubator, last week announced its receipt of a $110,000 Phase I Small Business Innovation Research grant from the National Institutes of Health's National Heart, Lung and Blood Institute.

The grant will fully fund the company's effort to begin developing a test for prions, the agent that causes mad cow disease, using its proprietary biosensor technology. CEO Joe Hernandez said the company should complete feasibility studies in about six months, when it will apply for a Phase II grant of up to $750,000 to fund further testing.

If successful, the company's diagnostics could be useful in detecting the human version of the disease as well, known as variant Cruetzfeldt-Jakob disease, Hernandez said.

We feel it appropriate to say that the technology, if useful in mad cow - testing, would be useful in the human variation of the disease further down the road, he said.

Innovative Biosensors in January commercialized its first product, a detection kit for a severe form of E. coli, and has been marketing the test to food processors for use in screening ground meat, milk, apple cider, yogurt, cheese and fresh vegetables for the pathogen.

The E. coli test uses proprietary technology called Canary, exclusively licensed three years ago from the Massachusetts Institute of Technology, where it was developed over eight years, to reduce the current 48-hour period of detection for the pathogen to about 7½ hours, said Hernandez.

The company has similar hopes for a possible mad cow detection kit, which also could drastically shorten the time required for diagnostic test results.

The company also is working on human tests for various diseases, including SARS, in an agreement with the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick.

But in the company's parallel development strategy, Hernandez said, the focus currently is on animal testing. Human testing involves far more obstacles, most posed by the Food and Drug Administration, the CEO added.

Though mad cow disease has made headlines in recent years with outbreaks in Europe - more than 183,000 cases confirmed in the United Kingdom in more than 35,000 herds by December 2003 - and infected cows appearing in the United States, the company chose to go with E. coli as its first product because the test already had been developed, Hernandez explained.

Though mad cow tests already exist, the beef industry wants one sensitive enough to test live animals, according to Dr. Richard Johnson, distinguished service professor of neurology, microbiology and neuroscience at the Johns Hopkins University School of Medicine and the Johns Hopkins Bloomberg School of Public Health.

Current tests require the animal to be dead before testing, said Johnson, who serves on mad cow advisory committees at the NIH and the FDA.

But a blood test for use in live cows - and even in humans - could be a boon to the nation's cattle industry, which has been banned from selling its product in Japan and Korea because of the disease, Johnson explained.

In human beings, a blood test for the pathogen could revolutionize the field of blood donation, which has been hard hit by fear of Creutzfeldt-Jakob, he added.

Source: The Daily Record (Baltimore)

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