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FDA Accepts IND for Procleix(R) West Nile Virus Assay: Test Expected to be Available for U.S. Mosquito Season




 

EMERYVILLE, Calif., March 25 /PRNewswire-FirstCall/ -- Chiron Corporation (Nasdaq: CHIR) today announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application submitted by Chiron's collaborator, Gen-Probe Incorporated, for an assay to screen blood donations for West Nile virus, a blood-borne pathogen transmitted by mosquitoes. The nucleic acid test (NAT) assay, marketed by Chiron and developed by Gen-Probe, is expected to be available for use under the IND in time for the upcoming U.S. mosquito season.

"West Nile virus only emerged as a threat to the safety of the blood supply in 2002. This assay reflects the commitment of both Chiron and Gen-Probe to move quickly to meet a critical public health need," said Jack Goldstein, president, Chiron Blood Testing. "We were able to respond rapidly because of the nature of the Procleix(R) system, which allows this assay to use the same instrumentation as the currently approved HIV-1/HCV test. We are working with our customers to ensure that they will be ready to implement the new assay and meet the timeline established by federal health officials."

West Nile virus is transmitted by mosquitoes carrying the virus. Infection with the virus can cause mild disease with flu-like symptoms or more severe disease characterized by encephalitis or meningitis. The FDA called upon the blood testing industry last year to develop an NAT assay to detect West Nile virus by mid-year 2003. Out of a total of more than 3,500 cases of West Nile infections documented in the U.S. last year, approximately 21 were believed to have been caused by blood transfusions or transplants, according to the FDA.

In 2002, Gen-Probe Incorporated received FDA approval for the Procleix(R) HIV-1/HCV Assay, an NAT test designed to detect the presence of all known HIV-1 subtypes and hepatitis C virus (HCV) genotypes during the very early stages of infection, when those agents cannot be detected by immunodiagnostic screening technologies. The Procleix HIV-1/HCV Assay is currently available commercially in 16 countries.

Chiron and Gen-Probe are currently developing the Procleix(R) Ultrio(TM) Assay, which adds an assay for hepatitis B virus (HBV) to the test for HIV-1 and HCV. The HBV component of this assay has the potential to close the window period between infection and detection of hepatitis B from 59 to 34 days, a reduction of 42% over currently available tests. European marketing evaluations for the Procleix Ultrio Assay are anticipated to begin in the first half of 2003. U.S. clinical trials are expected to begin in the second half of 2003.

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.

This news release contains forward-looking statements, including statements regarding product development initiatives, new product marketing, and future product sales, that involve risks and uncertainties and are subject to change. A full discussion of the company's operations and financial condition, including factors that may affect its business and future prospects, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2002, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, and marketing effectiveness. In particular, there can be no assurance that Chiron will successfully develop and receive approval to market new products, or achieve market acceptance for such new products.

Consistent with SEC Regulation FD, we do not undertake an obligation to update the forward-looking information we are giving today.

NOTE: Procleix and Ultrio are trademarks of Chiron Corporation.

SOURCE Chiron Corporation

Web Site: http://www.chiron.com



 


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Information in this article was accurate in March 25, 2003. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.