Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
PRNewswire - December 11, 2003
"We are very pleased to begin clinical trials of the Procleix Ultrio Assay in direct response to requests from major blood bank customers," said Henry L. Nordhoff, chairman, president and CEO of Gen-Probe. "The addition of an HBV assay provides another layer of protection for the blood supply."
"The start of clinical trials of the Procleix Ultrio Assay marks a major milestone in the continuing expansion of the Procleix franchise," said Jack Goldstein, president, Chiron Blood Testing. "This achievement demonstrates the long-standing commitment of Chiron and Gen-Probe to attain the highest possible standards in the safety and supply of blood products in the U.S. and around the world."
The Procleix Ultrio Assay was developed by Gen-Probe in collaboration with Chiron. The test, which will be distributed and marketed by Chiron, adds an assay for HBV to the previously approved Procleix(R) HIV-1/HCV Assay. The Procleix Ultrio Assay is designed to detect the presence of all known HIV-1 groups and subtypes and HCV and HBV genotypes in human plasma during the very early stages of infection, when those agents are present but cannot be detected by immunodiagnostic tests. The HBV component of the assay has the potential to reduce the window period between infection and detection of hepatitis B from 59 to 34 days, an improvement of 42 percent over currently available tests.
The new test, initially being evaluated on the semi-automated instrumentation system, will be used at three blood centers in the United States under an investigational new drug (IND) application. Clinical trials of the Procleix Ultrio Assay on the semi-automated instrumentation will establish a benchmark of equivalence for the clinical trial of this assay on the Procleix(R) TIGRIS(R) instrumentation system.
Hepatitis B is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. Hepatitis B infection can lead to liver failure, cirrhosis or cancer. According to the World Health Organization, more than 350 million people worldwide are chronically infected with the hepatitis B virus. More than one million people die annually as a result of HBV infections.
Amplified nucleic acid testing (NAT) is a highly sensitive method of detecting infectious organisms in donated blood, thereby improving the safety of the world's blood supply. The Procleix Ultrio Assay uses a family of technologies developed by Gen-Probe, including a unique nucleic acid amplification technique called transcription-mediated amplification (TMA). Researchers have demonstrated that TMA technology, by efficiently amplifying the genetic contents of each specific virus, allows significantly earlier detection of infection than tests that rely on antibody or viral protein detection.
About Procleix(R) System
The Procleix(R) System incorporates state-of-the-art NAT technology to detect viral RNA and DNA in donated blood and plasma during the very early stages of infection, when these infectious agents are present but cannot be detected by immunodiagnostic tests. The Procleix HIV-1/HCV Assay has been commercially available in Europe since 1999 and was granted FDA approval in 2002. The Procleix System is approved for use in 16 countries and is under evaluation in several other European, South American and Asian countries.
About Chiron
Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: BioPharmaceuticals, Vaccines and Blood Testing. For more information about Chiron, visit the company's website at http://www.chiron.com. For more information about Chiron Blood Testing visit http://www.eBloodBank.com.
About Gen-Probe
Gen-Probe Incorporated, founded in 1983, is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid testing products used for the clinical diagnosis of human diseases and for screening donated human blood. Using its patented NAT technology, Gen-Probe has received FDA approvals or clearances for more than 60 products that detect a wide variety of infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Additionally, the Company developed and manufactures the only FDA-approved blood screening assay for the simultaneous detection of HIV-1 and HCV, which is marketed by Chiron Corporation. Gen-Probe and Bayer Corporation have formed a collaboration to develop, manufacture and market nucleic acid diagnostic tests for certain viral organisms, and under the agreement Bayer has the right to distribute these tests, including the recently approved VERSANT(R) HCV Qualitative Assay. Gen-Probe has 20 years of nucleic acid detection research and product development experience, and its products are used daily in clinical laboratories and blood collection centers throughout the world. Gen-Probe is headquartered in San Diego, California and has approximately 700 employees. Additional information about the Company can be found on the Internet at http://www.gen-probe.com.
This news release contains forward-looking statements about the companies' expectations, beliefs, plans, objectives, assumptions or future events or performance, including statements regarding product development initiatives, the success of clinical trials, new product marketing, and future product sales, that involve risks, uncertainties and assumptions and are subject to change. Forward-looking statements are not guarantees of performance. A full discussion of Chiron's and Gen-Probe's operations and financial conditions, including factors that may affect the companies' businesses, operating results and future prospects, is contained in documents the companies have filed with the SEC, including the forms 10-K for the year ended December 31, 2002, and the companies' quarterly and current reports, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the companies' actual performance to differ from current expectations, including the outcome and timing of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, marketing effectiveness, the success of collaborations, third-party distributors and suppliers. In particular, there can be no assurance that Chiron or Gen-Probe will successfully complete clinical trials of new products, develop and receive approval to market new products, or achieve market acceptance for such new products.
The companies do not undertake any obligation to update the forward-looking information we are giving today to reflect subsequent events.
NOTE: Procleix and Ultrio are registered trademarks of Chiron Corporation. TIGRIS is a registered trademark of Gen-Probe Corporation.
SOURCE Chiron Corporation
Web Site: http://www.chiron.com
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