SAN DIEGO, March 31 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated has submitted to the U.S. Food and Drug Administration (FDA) an amendment to its Biologics License Application (BLA) for the PROCLEIX(R) ULTRIO(R) assay on the PROCLEIX(R) enhanced semi-automated system (eSAS), the Company announced today.
The ULTRIO assay was developed to simultaneously detect human immunodeficiency virus type 1 (HIV-1), hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissues. The amendment responds to questions asked by the FDA in an October 2005 "complete review letter" regarding the ULTRIO assay.
Gen-Probe originally submitted its BLA for the ULTRIO assay in September of 2004. The assay is approved for commercial blood screening use in many countries outside the United States.
Separately, Gen-Probe reiterated that it intends to submit a 510(k) application for the fully automated PROCLEIX TIGRIS system to run the PROCLEIX WNV assay, a blood screening test for the West Nile virus, by the end of April. The WNV assay was approved by the FDA in December 2005 to run on the eSAS. The Company intends to submit a 510(k) application for the ULTRIO assay on the TIGRIS system following clearance of the system for the WNV assay.
PROCLEIX and ULTRIO are trademarks of Chiron Corporation, Gen-Probe's worldwide blood screening partner. TIGRIS is a trademark of Gen-Probe.
About Gen-Probe
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 has more than 20 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. 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 new products, potential regulatory approvals and customer adoption 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 new products, including the PROCLEIX ULTRIO assay and the PROCLEIX TIGRIS system, will not be cleared for marketing in the timeframes we expect, if at all, (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 PROCLEIX ULTRIO and PROCLEIX WNV assays and the PROCLEIX TIGRIS system, may not develop as expected, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are dependent on Chiron and other third parties for the distribution of some of our products. The foregoing describes 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 858-410-8673
Gen-Probe IncorporatedCONTACT: Michael Watts, Sr. director, investor relations and corporatecommunications of Gen-Probe, +1-858-410-8673
Web site: http://www.gen-probe.com/
