Press Releases
Novartis to market newly approved PROCLEIX® TIGRIS® System in U.S. as the first fully automated system for West Nile virus blood screening
State-of-the-art blood screening system enables individual donor testing, ensures rapid delivery of West Nile virus-screened blood to hospitals
Blood centers able to meet blood supply demands during high volume emergencies
Emeryville, CA - March 2, 2007 - Novartis announced today that the U.S. Food and Drug Administration (FDA) has cleared the PROCLEIX® TIGRIS® System, the first fully automated nucleic acid testing system, to screen donated blood, organs and tissue for the West Nile virus.
Developed by Gen-Probe and marketed by Chiron, a Novartis business, the PROCLEIX TIGRIS System provides blood centers a fully automated platform for Nucleic Acid Testing (NAT), ensuring rapid delivery of virus-screened blood to hospitals and clinics nationwide. The high-throughput PROCLEIX TIGRIS System allows blood centers to process 1,000 blood samples in under 14 hours, enabling high volume individual donor testing.
"West Nile virus is a serious threat to the nation's blood supply. With rates of human infection increasing in 2006, reducing the spread of West Nile virus and other infectious diseases is a priority for blood centers nationwide," said Donald Doddridge, President-elect of America's Blood Centers and President of Florida Blood Services. "The ability to combine the PROCLEIX® West Nile Virus Assay with the PROCLEIX TIGRIS System will significantly boost the efficiency of blood center operations without sacrificing the level of blood safety."
The PROCLEIX TIGRIS System delivers increased throughput capacity through full automation, including target capture, nucleic acid amplification and detection, in a compact-size instrument. In addition, the system's full automation capabilities allows blood centers to increase blood sample processing during high volume or emergency situations, such as during the peak West Nile virus or mosquito season, without the need for additional resources.
"Our goal is to provide innovative and state-of-the-art technologies to blood centers that will effectively safeguard the nation's blood supply against harmful pathogens and improve blood center operations," said Gene Walther, President of Chiron and Global Head of Diagnostics. "The clearance of the PROCLEIX Tigris System is a milestone for the industry and, for the first time, allows blood centers a fully automated nucleic acid testing solution to rapidly detect the West Nile virus, a potentially fatal infectious disease."
The PROCLEIX TIGRIS System has been utilized by select blood centers nationwide to screen for the West Nile virus under an Investigational New Drug (IND) application since August 2004. Since then, millions of units of donated blood have been screened by the system intercepting West Nile virus-positive blood that otherwise may have infected patients with the virus.
More about the PROCLEIX TIGRIS System
The PROCLEIX TIGRIS System is the first fully automated system for state-of-the art nucleic acid testing (NAT). Developed by Gen-Probe and marketed by Chiron, a Novartis business, the PROCLEIX TIGRIS System requires minimal operator involvement compared to semi-automated systems. The PROCLEIX TIGRIS System has been CE-approved for use with the PROCLEIX® ULTRIO® Assay for commercial blood screening of HIV, Hepatitis C and Hepatitis B in Europe since 2004. It has also been CE-approved in Europe for use with the PROCLEIX West Nile Virus Assay since 2006 and is now approved for commercial use in the U.S. with the PROCLEIX West Nile Virus Assay. For more information about the PROCLEIX TIGRIS System, visit http://www.chiron.com.
About West Nile virus (WNV)
WNV is a mosquito-borne virus associated with a human form of the disease ranging from mild, flu-like symptoms to severe neurological disease, including encephalitis (inflammation of the brain) and meningitis (inflammation of the spinal cord and membranes of the brain). The first confirmed U.S. death resulting from transmission through donated blood was reported in 2002. In the fall of 2002, the U.S. Food and Drug Administration challenged industry to develop a test for direct detection of WNV in donated blood by the summer of 2003. Within nine months, Gen-Probe and Chiron developed the PROCLEIX West Nile Virus Assay and brought it to market under an IND. According to the U.S. Centers for Disease Control and Prevention, WNV is an epidemic with more than 19,000 human cases of WNV infection reported since 2003, including 644 deaths.
Disclaimer
This release contains certain forward-looking statements, relating to the Group's business, which can be identified by the use of forward-looking terminology such as "goal", or similar expresssions, or by express or implied discussions regarding potential future sales of PROCLEIX. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that PROCLEIX will reach any particular sales levels. In particular, management's expectations regarding PROCLEIX could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected trial results; competition in general; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; increased government, industry, and general public pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the U.S. Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis Vaccines and Diagnostics is a new division of Novartis focused on the development of preventive treatments and tools and was formed following the recent acquisition of Chiron Corporation. The division consists of two activities: Vaccines and Chiron. Novartis Vaccines is the world's fifth-largest vaccines manufacturer and second-largest supplier of flu vaccines in the US. Vaccine products also include meningococcal, pediatric and travel vaccines. Chiron, the blood testing and molecular diagnostics business unit, is dedicated to preventing the spread of infectious diseases through the development of novel blood-screening tools that protect the world's blood supply.
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