Chiron Receives Approval in France to Market Nucleic Acid Blood Tests For HIV-1 and HCV / First NAT Blood Tests Approved Worldwide
21.09.1999, 15:12
EMERYVILLE, Calif. (PROTEXT) - Chiron Corporation (Nasdaq:
CHIR) today announced that it received approval from the French
Ministry of Health (AFSSAPS) to market to blood banks throughout
France its combination nucleic acid test (NAT) to simultaneously
detect human immunodeficiency virus type 1 (HIV-1) and hepatitis
C virus (HCV). The combination HIV/HCV test, developed and
manufactured by Gen-Probe Incorporated, is marketed by Chiron.
Previously the Ministry of Health had mandated that the entire
blood supply of France, 2.7 million blood donations per year, be
screened by the year 2000 for HCV using a nucleic acid testing
method. The action by the French government makes France the
first nation to formally grant marketing approval for the
advanced screening technology.
"We believe Chiron's TMA combination assay further enhances
the safety of France's blood supply, which is already very safe
due to stringent regulation and controls," said Professor
Philippe Rouger, president of the French Society of Blood
Transfusion and managing director of the National Institute of
Blood Transfusion. "We believe Chiron's TMA assay is an easy and
efficient addition to the routine screening of blood donations."
"This approval of NAT tests is a major milestone. France wants
to quickly implement new, more sensitive technology that has the
capability of identifying viral contaminants in blood sooner
after a donor is infected than immunoassay screening
technologies," said Rajen Dalal, president of Chiron blood
testing. "The AFSSAPS is respected as a leading regulatory agency
and its timely decision will be noted by authorities around the
world."
The test, called the CHIRON(R) HIV-1/HCV TMA Assay, is
intended to detect HIV-1 and/or HCV viral RNA in human plasma,
and it will be used to screen blood donations on individual donor
specimens. Chiron's NAT kit utilizes transcription-mediated
amplification (TMA), a technology developed by San Diego-based
Gen-Probe Incorporated. The use of the TMA-based kit, with the
associated hardware and software, enables blood bank technicians
to screen large numbers of samples quickly and with low risk of
contamination. These features make it possible to rapidly
identify infected donations without delaying the routine supply
of blood components. Alternative NAT methods are more complex and
time consuming.
Currently, donated blood and plasma are routinely screened
with immunoassays to protect the population from blood-borne
diseases such as HIV and HCV. Nucleic acid testing is a new
technology capable of directly detecting even small amounts of
infectious viruses in blood.
In the United States, FDA-regulated studies are now being
conducted under an Investigational New Drug Application (IND) to
evaluate the performance of Chiron's assays, and to demonstrate
the effectiveness of nucleic acid testing for improving the
safety of donated blood and blood products. Approximately 70
percent of U.S. whole blood donations are being tested using the
CHIRON(R) HIV-1/HCV TMA Assay.
About Transcription Mediated Amplification Technology
Researchers have demonstrated that TMA technology, by
efficiently amplifying the nucleic acids of the virus, allows
direct detection of the infection. 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.
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, 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. This approach is supported by research
strengths in recombinant proteins, genomics, small molecules,
gene therapy and vaccines. For further information, visit the
company's website at www.chiron.com. ots Original Text Service:
Chiron Corporation Internet: http://www.newsaktuell.de Contact:
Julie Wood, Director, Corporate Communications and Investor
Relations, 510-923-6686, or Gabrielle Friedly, Manager, Corporate
Communications, 510-923-6905, both of Chiron Corporation Web
site: http://www.chiron.com
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