EMERYVILLE, Calif. (PROTEXT) - Chiron Corporation (Nasdaq:
CHIR) today announced that the Australian Red Cross Blood Service
(ARCBS) will use the company's nucleic acid testing (NAT) system
to screen the country's entire blood supply for hepatitis C (HCV)
and the human immunodeficiency virus-1 (HIV). Chiron's
combination HIV/HCV test, developed and manufactured by Gen-Probe
Incorporated, is expected to be fully implemented in Australia by
mid-2000. The advanced screening test, which incorporates
sophisticated new technology, will be used to routinely screen
the Australian blood supply, approximately one million blood
donations per year.
"The ARCBS's adoption of NAT technology is another step
towards ensuring the Australian blood supply remains among the
safest in the world," said Rajen Dalal, president of Chiron Blood
Testing. "Chiron's system is the only test available that allows
blood centers to simultaneously detect both HCV and HIV," he
added.
Currently, donated blood and plasma are routinely screened
with antibody tests, which detect the body's immune response, to
protect the population from blood-borne diseases such as HIV and
HCV. In contrast, NAT is capable of directly detecting small
amounts of infectious viruses in blood, further increasing the
safety of the blood supply. In addition, Chiron's NAT system,
which utilizes Gen-Probe's proprietary transcription-mediated
amplification (TMA), enables users to perform testing using
either pooled donations or in a single-donor format. All current
non-NAT blood screening protocols utilize single-donor testing
rather than pooling multiple donations, and regulatory
authorities worldwide have expressed their interest in ultimately
using single-donor testing with NAT.
"Our goal in implementing NAT is to effectively add an extra
layer of safety to our blood supply," said Robert Hetzel, M.D.,
chief executive officer of the Australian Red Cross Blood
Service. "We chose Chiron because we saw the potential of the TMA
technology, and we were attracted by the complete package that
Chiron offered us including the provision of instrumentation,
software, and training support," he added.
Under the agreement, Chiron, through its Australian
subsidiary, will assist in the implementation of testing to
screen every blood donation collected by ARCBS. Testing will be
conducted at five ARCBS testing sites. Initially, two of the
sites, making up approximately 20 percent of the country's blood
supply, will conduct single-donor testing while the remaining
sites will screen using small sample pools.
FDA-regulated studies are currently being conducted in the
U.S. under investigational new drug (IND) applications to
evaluate the performance of TMA technology and to demonstrate the
effectiveness of NAT for improving the safety of donated blood
and blood products. Currently more than 70 percent of U.S. blood
donations are being tested using Chiron's NAT system. Regulatory
approval for Chiron's NAT system has been obtained in France and
is expected in Australia early next year.
About Transcription Mediated Amplification Technology
Researchers have demonstrated that TMA technology efficiently
amplifies the nucleic acids of a virus, providing direct
detection of the infection. This provides for earlier
identification of even small amounts of virus particles in the
blood stream. Current tests, which rely on antibody or viral
protein detection, take much longer since antibodies are formed
in response to the infectious agents. This can be as long as 22
days for HIV and up to 80 days or more for HCV according to The
New England Journal of Medicine (1996; 334(26)). TMA technology
has the potential to reduce detection time, or the "window
period," by about 50 percent for HIV and by 70 percent or more
for HCV. Chiron's nucleic acid test, the CHIRON(R) HIV-1/HCV TMA
Assay, is intended to detect HIV-1 and/or HCV viral RNA in human
plasma.
About Chiron Blood Testing
Chiron Blood Testing is a leading provider of products used by
the blood banking industry to ensure safety of the world's blood
supply and to protect the public health. Through its joint
business with Ortho-Clinical Diagnostics, Inc., Chiron develops
and markets immunoassay screening and supplemental tests for
blood-borne infectious diseases, such as hepatitis B and C, and
AIDS. The company also manufactures RIBA SIA confirmatory tests,
as well as hepatitis and retroviral antigens. In addition, Chiron
is collaborating with Gen-Probe Incorporated in the development
and marketing of improved infectious disease blood screening
tests incorporating novel and highly sensitive nucleic acid
amplification technology.
About Chiron Corporation
Chiron Corporation, headquartered in Emeryville, California,
is a leading biotechnology company that participates in three
global healthcare markets: biopharmaceuticals, vaccines and blood
testing. The company is applying a broad and integrated
scientific approach to the development of innovative products for
preventing and treating cancer, infectious diseases and
cardiovascular disease. For further information, visit the
company's website at www.chiron.com .
This document contains forward-looking statements that are
subject to risk and uncertainty. There are a number of factors
that could cause the company's actual performance to differ
materially from expectations. These and other factors investors
should consider are more thoroughly described in the company's
Securities and Exchange Commission filings, including the Form
10-Q and Form 10-K. ots Original Text Service: Chiron Internet:
http://www.newsaktuell.de Contact: Julie Wood, Senior Director,
Corporate Communications and Investor Relations, 510-923-6686, or
Gabrielle Friedly, Manager, Corporate Communications, 510-923-
6905, both of Chiron Web site:
http://www.chiron.com
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