Gen-Probe Incorporated Receives FDA Approval For PROCLEIX(R) West Nile Virus Blood Screening Assay
SAN DIEGO, Dec. 1 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval to use the Company's PROCLEIX(R) West Nile virus (WNV) assay to screen donated human blood on the PROCLEIX enhanced semi-automated instrument system (eSAS).
"FDA approval of our West Nile virus assay represents another significant milestone in our efforts to help safeguard the U.S. blood supply with our innovative nucleic acid testing technologies," said Henry L. Nordhoff, chairman, president and chief executive officer of Gen-Probe. "The entire development program for this highly accurate assay, which began only three years ago, has been a tremendous success story for Gen-Probe, and once again demonstrates our ability to rapidly commercialize molecular diagnostic tests that improve human health. We appreciate the significant support we received from FDA and the National Heart, Lung and Blood Institute, which were instrumental in the development and approval of this assay."
Since June of 2003, U.S. blood centers have used the PROCLEIX WNV assay to screen more than 29 million units of donated blood under an investigational new drug (IND) application. This experimental testing has intercepted approximately 1,500 West Nile-infected units, thereby preventing transfusion of contaminated blood into as many as 4,500 people.
Based on the early approval of the WNV assay on the eSAS, as well as recent discussions with the FDA and customers, Gen-Probe has decided to accelerate the necessary regulatory filings for use of the WNV assay on the Company's fully automated, high-throughput TIGRIS system. Gen-Probe intends to file for this clearance in the first part of 2006. The Company then expects to pursue clearance of the TIGRIS system to run the PROCLEIX ULTRIO assay, which simultaneously detects HIV-1, hepatitis C virus and hepatitis B virus.
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. The first confirmed U.S. death resulting from transmission through donated blood was reported in 2002. In the fall of 2002, the FDA challenged industry to develop a test for the direct detection of WNV in donated blood by the summer of 2003. Within nine months, Gen-Probe and its partner Chiron had developed the PROCLEIX WNV assay and began distributing it under an IND. WNV has continued to be a significant public health threat since that time. According to the U.S. Centers for Disease Control and Prevention, more than 2,700 human cases of WNV infection have occurred in 2005.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe markets a broad portfolio of products that use the Company's patented technologies to detect infectious microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. The Company also 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. In addition, Gen-Probe's TIGRIS instrument is the only fully automated, high-throughput NAT system for diagnostics and blood screening. Gen-Probe has more than 20 years of NAT expertise, and its products are used daily in clinical laboratories and blood collection centers worldwide. Gen-Probe is headquartered in San Diego and employs approximately 900 people. For more information, go to www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about our expectations, beliefs, plans, objectives, assumptions or future events or performance, are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "believe," "will," "expect," "anticipate," "estimate," "intend," "plan," and "would." For example, statements concerning Gen-Probe's financial condition, possible or expected future results of operations, regulatory approvals, growth opportunities, and plans and objectives of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that use of the West Nile Virus assay or the ULTRIO assay may not be approved for use on the TIGRIS System (ii) the risk that we may not earn or receive milestone payments from our collaborators, (iii) the possibility that the market for the sale of our new products, such as our TIGRIS system and PROCLEIX WNV and ULTRIO assays, may not develop as expected, (iv) the enhancement of existing products and the development of new products may not proceed as planned, (v) the risk that our PROCLEIX ULTRIO assay may not be approved by regulatory authorities and commercially available in the time frames we anticipate, or at all, (vi) we may not be able to compete effectively, (vii) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, (viii) we are dependent on Chiron, Bayer and other third parties for the distribution of some of our products, (ix) changes in third-party reimbursement policies regarding our products could adversely affect sales of our products, (x) the risk that our intellectual property may be infringed by third parties or invalidated, and (xi) our involvement in patent and other intellectual property and commercial litigation could be expensive and could divert management's attention. The foregoing list sets forth some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact: Michael Watts Sr. director, investor relations and corporate communications 858-410-8673Gen-Probe Incorporated
CONTACT: Michael Watts, Sr. Director, Investor Relations and CorporateCommunications, +1-858-410-8673
Web site: http://www.gen-probe.com/