Two days before the announcement that bovine spongiform encephalopathy was found in a Canadian cow, Howard Urnowitz stood before a crowd of fellow scientists in Ann Arbor, Michigan, and told them he was releasing the world’s first live test for the prion disease.
Until May 18, tests for BSE could only be done by an autopsy, studying the brain of the dead animal.
Because no live test has been available for BSE, millions of cattle in Great Britain were destroyed in an effort to remove the disease and restore faith in the British beef industry.
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From all the animals slaughtered, 188,000 British cattle were found to have the mutated prions that cause buildups of the protein and the resulting spongy structure in the brains.
Currently, the test involves taking a sample of the brain stem through the spinal cord canal. A half-gram piece of the obex, a region of the brain stem, is homogenized chemically or mechanically.
The resulting liquid is then treated with a combination of chemicals. This reagent solution breaks down normal prion proteins leaving only BSE prions. It is then mixed with a BSE antibody that emits a type of light that confirms the test.
“I was shocked to hear about what was happening up there. We only just made the announcement,” said Urnowitz of Chronix Biomedical in San Jose, California.
Scientists around the world have spent a decade trying to create a live test for transmissible spongiform encephalopathy. Two other companies, one Swiss and the other German-Israeli, have also produced live tests, but none has brought one to the market-ready stage.
Next month Chronix is applying for licensing of the test in Germany, where it was developed. The company expects to have German approval in September and approval by the European Union the following month. Applications for North American regulatory approval of the test will follow in early 2004.
Urnowitz is working with German BSE researcher Bertram Brenig, Gottingen University’s veterinary school.
Brenig admitted research is “challenging, but we were in a good place to be doing it.”
Gottingen University performs 1,200 to 1,400 BSE post-mortem tests each week, said Brenig.
Urnowitz developed a genetic test that relies on RNA chemicals in the blood. If an animal has the prion disease, a particular RNA pattern will be present.
Brenig said Canadian officials might find that if they test widely, “like the rest of the world seems to find when they begin intensive testing, that there is more BSE than you might think.”
Canada now tests about 1,000 animals annually for BSE, said Chris Clark, a University of Saskatchewan veterinary medicine professor and researcher.
“This is well above the 300 or so that the European Union’s scientific steering committee recommends as a standard for testing.”
Added Brenig: “It is only a matter of time until the United States begins to test more routinely and they will find they have BSE in their national herd, just like the rest of the world.”
Clark and Urnowitz agreed, saying that if a live test was available and every animal could be tested, that a greater incidence of the disease would be found.
“Is our case a unique situation? A sporadic incident? If you don’t monitor every animal or at least very large numbers of animals, you don’t know when it comes to something this rare,” said Clark.
