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Feds approve faster anthrax exposure test

Mayo Clinic
Food and Drug Administration (FDA)
Centers for Disease Control & Prevention

(CNN) -- The federal government has approved a test that promises to make it easier and faster for local agencies to determine if a person is infected with anthrax.

The need for the test became apparent in October 2001, after a number of people received anthrax spores in the mail and five of the 22 who became sick died.

"There weren't any standard, readily available tests out there," said Andrew Levin, president and CEO of Immunetics Inc. of Boston, the company that developed the new test.

During the 2001 anthrax scare, only government agencies, such as military laboratories and the Centers for Disease Control and Prevention, could determine whether people were infected, Levin said.

The Food and Drug Administration approved the new tests Friday, and Immunetics will sell individual tests to the government for $5 each.

"The approval shows how cooperative work between government agencies and industry can lead to the development of diagnostic tests for biothreat agents and emerging infectious diseases," the CDC said Monday in a news release.

In addition to being a biothreat, anthrax can be contracted by people who breathe or come into close contact with spores from infected cattle, sheep or other herbivores.

The newly-approved test determines whether a sample of blood contains antibodies to anthrax. Such antibodies are detectable about two weeks after exposure.

Under a government contract, Immunetics will send its test kits to 150 laboratories around the country. Levin predicted that the international community would also be placing orders with the company, which is privately held.

Levin said he could not predict how big a market the test will represent.

"Anyone in the biodefense, developing-products area is probably wondering the same question. It's not exactly a market with a history," he said.

Levin's test takes 25 minutes, and it indicates exposure with a color change in the vial's contents, he said. Other tests require about four hours.

In pre-approval studies, the test had a false-positive rate of less than 1 percent; and a false-negative rate of zero percent, Levin said. "We picked up everything we were supposed to."

Levin said he would like to use the test to examine the efficacy of anthrax vaccines, which work by stimulating the production of antibodies to confer protection. That would require a separate FDA approval.

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