Press Releases
Novartis Receives Health Canada Approval for First Fully Automated Nucleic Acid Testing Solution to Screen for West Nile Virus
- Approval of PROCLEIX® WNV Assay and PROCLEIX® TIGRIS® System to enable Canadian blood banks to screen for West Nile virus in blood, tissue and organ donation
- Nucleic Acid Testing technology detects West Nile virus RNA during early stages of infection, reduces the risk of transfusion transmission of West Nile virus
Emeryville, CA - May 15, 2007 - Novartis announced today that Health Canada has approved the PROCLEIX® West Nile Virus (WNV) Assay and the PROCLEIX® TIGRIS® System, the first fully automated Nucleic Acid Testing (NAT) solution to screen for the West Nile virus.
Developed by Gen-Probe and marketed by Chiron, a Novartis business, the PROCLEIX WNV Assay and PROCLEIX Tigris System use state-of-the-art NAT technology to detect viral RNA during the early stages of West Nile virus infection improving the safety of blood, organ and tissue donation.
"Of major concern is the potential for transmission of West Nile virus, which not only can be transmitted by mosquitoes, but also through contaminated blood, organ and tissue donation," said Tony Mazzulli, MD, FRCP, Deputy Chief of Microbiology at Mount Sinai Hospital in Toronto, Ontario. "The ability to use the first fully automated nucleic acid test for West Nile virus will enable blood centers, clinics and hospitals in Canada to reliably detect the virus, often in people who are not yet showing symptoms."
West Nile virus 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 or membranes of the brain). More than 80 percent of those infected by West Nile virus do not exhibit symptoms increasing the risk of transmission through blood, tissue and organ donation. According to the Public Health Agency of Canada, West Nile virus is considered an epidemic in Canada and the rest of North America with more than 2,000 cases of human infection recorded in Canada alone since 2002.1
"Over the past few years, the introduction of PROCLEIX assays and systems by Chiron have dramatically improved the safety of the world's blood supply from potentially fatal infectious diseases," said Gene Walther, President of Chiron and Global Head of Diagnostics. "We remain determined to minimize the public health threat of West Nile virus through blood transfusion across North America, including Canada, Mexico and the U.S. Health Canada's approval of our PROCLEIX WNV Assay and PROCLEIX TIGRIS System is a significant event in fighting the spread of West Nile virus."
The PROCLEIX WNV Assay was approved by the FDA in December 2005 and was approved in the U.S. for use with the PROCLEIX TIGRIS System in March 2007. Since its introduction, millions of units of donated blood have been screened intercepting West Nile virus-positive blood that otherwise may have infected patients with the virus.
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 or membranes of the brain). In 2002, scientists discovered people could be infected with West Nile virus in other ways, including blood transfusions, organ/tissue transplants and prenatal infection to unborn babies. The U.S. Food and Drug Administration (FDA) challenged industry to develop a test for direct detection of West Nile virus in donated blood by the summer of 2003. Within nine months, Gen-Probe and Chiron developed the PROCLEIX WNV Assay. For more information about the transmission of West Nile virus, please go to http://www.phac-aspc.gc.ca/wn-no/gen_e.html.
About PROCLEIX® Assays
PROCLEIX Assays incorporate 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 infectious agents are present but cannot be detected by immunodiagnostic tests. Developed in collaboration with Gen-Probe Incorporated, the PROCLEIX WNV Assay is the first NAT solution approved by Health Canada and the FDA for the detection of the West Nile virus in plasma specimens from individual donors. It is also CE marked in Europe. The PROCLEIX® HIV-1/HCV Assay is approved for use in the United States, the European Union, Australia and major markets in Asia. The PROCLEIX® ULTRIO® Assay for the simultaneous detection of HIV-1, HCV and HBV has been commercially available in Europe since early 2004. For more information about various PROCLEIX Assays, visit http://www.chiron.com..
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. and Canada with the PROCLEIX West Nile Virus Assay. For more information about the PROCLEIX Tigris System, visit http://www.chiron.com.
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 "first", 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 division of Novartis focused on the development of preventive treatments and tools. 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.
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Grou'’s businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
PROCLEIX is a registered trademark of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a registered trademark of Gen-Probe Incorporated.
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References
- 1 Public Health Agency of Canada Web site; West Nile Virus Monitor http://www.phac-aspc.gc.ca/wnv-vwn/index.html