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Bio-Rad Comments on Positive Confirmation of BSE Test Result
Company Affirms the Accuracy and Reliability of Its Rapid Screening Test
HERCULES, Calif., June 29 /PRNewswire-FirstCall/ -- On Friday, June 24th the
U.S. Department of Agriculture (USDA) announced the results of final
confirmatory tests conducted at the world reference laboratory for BSE, the
Veterinary Laboratories Agency (VLA), in Weybridge, England and the USDA's
laboratory in Ames, Iowa. Results have confirmed that the sample from an animal
that tested "initial reactive" on screening tests in November 2004 has tested
positive for BSE (bovine spongiform encephalopathy). These results corroborate
the initial findings of two Bio-Rad BSE screening tests conducted on the
suspect cow last November. According to the USDA, the VLA conducted a
combination of confirmatory tests including IHC (immunohistochemistry) and
Western Blot methods to confirm this case of BSE.
"These results are consistent with our experience in 27 countries around the
world -- that the Bio-Rad BSE screening test has an exceptional level of
accuracy and is highly regarded in the scientific community," said Bio-Rad Vice
President Brad Crutchfield. "We are pleased that the test has been performing
as expected in the USDA's BSE surveillance program."
According to the USDA, the disease was difficult to detect because the animal
had a very low level of abnormal prion protein in the brain and those
abnormalities were isolated and not consistent throughout the brain. As a
result, the USDA's confirmatory tests produced inconsistent -- both positive
and negative results -- from sample to sample. It is for this reason that the
high sensitivity of the Bio-Rad test is a critical factor in the success of the
USDA surveillance program because it identifies even the most
difficult-to-detect abnormal prions.
Bio-Rad is the leading provider of tests used for detecting TSEs (Transmissible
Spongiform Encephalopathies). To date, the company has provided more than 35
million BSE tests to laboratories throughout Europe and Japan. Independent
field studies have shown the Bio-Rad BSE test to have the highest level of
sensitivity and specificity of any rapid screening test available. The test
detects the presence of the resistant form of prion protein, or PrPres, linked
to BSE and can identify these prions at extremely low levels. This capability
to detect very low levels of prions helps assure that BSE infected animals do
not go undetected.
The USDA initiated its enhanced BSE surveillance program in June 2004. Since
then, USDA-approved laboratories and the National Veterinary Service Laboratory
(NVSL) have used the Bio-Rad rapid BSE test to screen nearly 400,000 cattle.
Bio-Rad also supplies the U.S. with tests for other TSEs, including its Chronic
Wasting Disease (CWD) test which is the only test approved by the USDA for use
on all three species affected with CWD (white tailed deer, mule deer and elk).
The company's screening test used to detect scrapie in sheep and goats was
recently licensed by the USDA.
Bio-Rad Laboratories, Inc. (http://www.bio-rad.com/) is a multinational
manufacturer and distributor of life science research products and clinical
diagnostics. It is based in Hercules, California, and serves thousands of
research and industry customers worldwide through a network of more than 30
wholly owned subsidiary offices.
Veterinary Laboratories Agency (VLA) is an executive agency of Great Britain's
Department for Environment, Food and Rural Affairs (DEFRA), consisting of a
regional network of 16 laboratories throughout the UK. The Agency provides all
sectors of the animal health industry with animal disease surveillance,
diagnostic services and veterinary scientific research. Since 1991, the VLA has
been the World Organization for Animal Health (OIE) Reference Laboratory for
scrapie and BSE and in 2001 the European Commission officially designated VLA
as the Community Reference Laboratory for TSEs. The VLA was responsible for the
first description of BSE in 1996 and the subsequent description of and research
relating to TSEs in other species.
Various statements made within this press release may constitute
"forward-looking statements" for purposes of the Securities and Exchange
Commission's "safe harbor" provisions under the Private Securities Litigation
Reform Act of 1995 and Rule 3b-6 under the Securities Exchange Act of 1934. The
forward-looking statements contained herein involve risks and uncertainties
that could cause results to differ materially from the Company's expectations.
DATASOURCE: Bio-Rad Laboratories, Inc.
CONTACT: Susan Berg, Corporate Communications of Bio-Rad Laboratories,
Inc., +1-510-741-6063, or
Web site: http://www.bio-rad.com/