Healthcare Industry News: Papillomavirus
News Release - September 24, 2007
Cepheid Enters Agreement To Exclusively License HPV Portfolio Developed by Quantovir ABQuantitative Detection of HPV Viral Load a Possible Indicator of Cervical Cancer Risk
SUNNYVALE, Calif., Sept. 24 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ) today announced that it has entered into an agreement to exclusively license the Human Papillomavirus (HPV) patent portfolio held by Quantovir AB of Sweden for the quantitative measurement of high-risk HPV types using DNA-based detection. Quantovir is believed to be the first to demonstrate that a molecular diagnostic test measuring the quantity, or viral load, of HPV DNA present in cervical specimens can be used to predict a woman's risk of developing cervical cancer. Cepheid plans to utilize Quantovir's technology to develop a new type of HPV test for the GeneXpert« System. Terms of the deal were not disclosed.
"The GeneXpert System is ideal for the rapid diagnosis of infectious organisms like Methicillin-resistant Staphylococcus aureus (MRSA), but it can also be used to generate actionable, treatment-determining results in other medical areas including oncology and pharmaocogenetics," said John L. Bishop, CEO of Cepheid. "With the GeneXpert System, molecular diagnostics is no longer reserved solely for the highly complex laboratory setting; it is also enabling the benefits of this technology to be realized in moderately complex settings. An HPV test for the GeneXpert System is expected to provide accurate PCR results in minutes rather than days in a variety of clinical settings."
Infection with HPV is associated with nearly all cases of cervical cancer, the second most common cancer in women worldwide.(1),(2),(3) In the U.S., the treatment of cervical cancer costs approximately $2 billion per year.(4)
Given the demonstrated correlation of the presence of HPV with cervical cancer, HPV DNA testing has become an important diagnostic determinant of cancer risk. However, current tests approved by the U.S. Food and Drug Administration do not measure sample adequacy, and thus cannot accurately quantitate HPV viral load. Cepheid's potential HPV test for the GeneXpert System is planned to be designed to measure HPV viral load, which may help to identify patients most at risk, making it unique among current HPV DNA testing products(5). "It is gratifying to see our research leading to the possible discovery of disease at a much earlier stage," said Professor Ulf Gyllensten of the Rudbeck Laboratory in Uppsala, Sweden. "Early detection delivers greater opportunities for improving patient outcomes."
Current recommendations state that HPV DNA testing may be used in conjunction with a Pap in women over 30, to follow patients with previous positive high-risk HPV screening results, or when Pap results are uncertain. Analysts have estimated the current domestic market for diagnostic preventative testing at approximately $600-700 million.
About Quantovir AB
Founded in 2001, Quantovir AB was formed as a natural continuation of years of research and development by Professor Ulf Gyllensten and his team at the department of Genetics and Pathology at the Rudbeck Laboratory, Uppsala University. Today, Quantovir AB is owned by Innovationsbron I Uppsala AB, Uppsala Universitets Holdingbolag UUAB together with a research group led by Professor Ulf Gyllensten at the Rudbeck Laboratory in Uppsala.
Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The Company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. Cepheid's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the Company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to product performance and usage in the clinical diagnostics market, potential size of certain clinical diagnostics markets and future products for the clinical market. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen development and manufacturing problems; our ability to successfully obtain regulatory approvals for additional products and to introduce new products in the clinical market; customer market acceptance of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; the impact of vaccinations in the target market; potentially lengthy sales cycles in some markets; reimbursement rates for the products; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2006 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
(1) Parkin DM, Pisani P, Ferlay J. Global cancer statistics. CA Cancer J Clin 1999;49:33-64
(2) Mahmud SM, Franco EL. An overview of epidemiological and public health research on HPVs presented at the 21st International Papillomavirus Conference in Mexico City, 20-26 February 2004. Papillomavirus Rep 2004;15:121-3.
(3) Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, et al. Human Papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189:12-9.
(4) Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: economic cost and quality of life. Annual Review of Public Health 2001;22:91-113.
(5) Viral load of human papilloma virus 16 as a determinant for development of cervical carcinoma in situ: a nested case-control study. The Lancet, Volume 355, Issue 9222, Pages 2189-2193 A. Josefsson, P. Magnusson, N. Ylitalo, P. S°rensen, P. Qwarforth-Tubbin, P. Andersen, M. Melbye, H. Adami, U. Gyllensten
**(Note: The cost estimates were originally presented in 1996 U.S. dollars, which were updated to 2000 U.S. dollars using the Medical Care Component of the Consumer Price Index [MCPI].)
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