Mayo test can detect anthrax quickly, officials say
Maura Lerner
Star Tribune
Published Nov 6 2001
Mayo Clinic scientists turned a back-burner idea for a rapid
anthrax test into the real thing in less than two months by
working "25 hours a day, 7 days a week and on fast forward,"
the project's top researcher said Monday.
The result is a DNA test that reportedly can detect anthrax in
people or an environment in as little as 30 minutes, rather than
days, said Dr. Franklin Cockerill, a Mayo microbiologist who
led the research team. "With the events of September 11, we
completely focused our activity on this project, putting all other
things aside," he said.
The test, announced Monday, will be distributed this week to
two dozen labs around the country, initially for free.
The manufacturer, Roche Diagnostics Corp., hopes to make it
available to hundreds more labs starting next month. The test
detects any form of anthrax, a Mayo spokesman said.
"What Dr. Cockerill and his team here at Mayo have been able
to accomplish in such a short period of time is simply
amazing," said Juergen Flach, a Roche vice president.
The scientists were quick to point out that the test has yet to be
used on people.
"However, we have found the test to be extremely accurate in
the lab setting," Cockerill said. That's "exciting news," he said.
Speed is of the essence in detecting anthrax, because it can kill
within days if it gets into the lungs. And it's difficult to
diagnose, because its early symptoms are flu-like.
"It will allow physicians to begin treating their patients who
have been exposed in a more timely fashion," Cockerill said. "It
will more quickly alleviate undue anxiety for people who
haven't been exposed."
Others, though, reacted with caution. A spokeswoman for the
U.S. Centers for Disease Control and Prevention said it has not
had a chance to evaluate the "efficiency and validity" of the
Mayo test. And Dr. Harry Hull, Minnesota's state
epidemiologist, said it still must prove itself in the field.
"This is something that is still in developmental testing," Hull
said. "So they don't know how valuable it is, and we have to
see."
Roche says it plans to seek expedited approval by the U.S. Food
and Drug Administration (FDA) by the end of the year. The
company's president, Martin Madaus, called it "our
contribution to the fight against bioterrorism." For now, the
FDA has authorized a limited distribution to the labs, a Roche
spokesman said.
Cockerill, an infectious disease specialist, had been working on
a possible anthrax test for months. He even published a brief
scientific paper about it last May, at a meeting in Florida.
"But it was definitely on the back burner," he said Monday.
"With the events of September 11, we jumped right in the fire."
Cockerill and his team developed the test using a high-tech
device the size of a "Krupps coffeemaker," he said. The device,
made by Roche, can quickly multiply DNA and check it for
infectious organisms.
Until September, Cockerill's team had been using the device
mostly to develop tests for such common infections as strep and
herpes.
Researchers took blood samples, "spiked" them with anthrax
and ran them through the device, called a LightCycler, with a
mix of chemicals.
The result, Cockerill said, was a test that could detect as few as
five anthrax bacteria in a sample of human blood. A patient
with inhaled anthrax would have millions of bacteria in the
blood, he noted.
Ordinarily, he said, it would take a year to develop such a test.
"My scientists have not had a lot of sleep."
Roche started gearing up to produce the test in mid-October,
Flach, the Roche vice president, said. "It took us less than four
weeks to have the first kits in the U.S.," which he called "record
time."
Will it work?
Questions surround the test, though. The scientists could not
say how accurate it may be or how soon after infection it would
work.
"In the lab, what we've been able to do is to demonstrate the
test worked extremely well," Cockerill said. But it wasn't
possible to assess how well it might work on people, he said.
"There has not been any clinical testing done. Hopefully, we
won't have the number of patients to do that validation."
However, he said the lab tests turned up no "false negatives."
Some of the details are being kept confidential, including the
chemical recipe used and the names of the other researchers.
"I would love to publish the results, but because of security
reasons we are a bit limited in doing that," Cockerill said. "This
technology is in essence a counteroffensive measure. We don't
want ... the ingredients to get in the hands of the wrong people."
Cockerill said that he is working to develop tests for other
organisms that could be used in bioterrorism but that "I can't
be any more specific."
Roche said it has enough tests now to provide to only 24 labs,
which it refused to identify. "The problem is, we don't have
enough product to give anyone else," said Dennis Coverdale,
spokesman for Roche Diagnostics in Indianapolis. "So we're
ramping up production between now and December." By then,
he said, the company hopes to make the test available to as
many as 400 labs.
For now, the company is providing the tests at no charge. But it
has not decided how much the kit will eventually cost. Flach
said it could be similar to that of Roche's HIV test kit, which
costs from $50 to $60.
Eventually, officials hope to distribute the test worldwide to
hospital labs, academic institutions and public health agencies.
-- Maura Lerner is at mlerner@startribune.com .
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