SAN DIEGO, Jan. 29 /PRNewswire-FirstCall/ -- Gen-Probe announced today that the Company has submitted to the U.S. Food and Drug Administration (FDA) a regulatory application to run the PROCLEIX(R) ULTRIO(R) blood screening assay on the fully automated TIGRIS(R) system, and that a post-marketing study of the assay to detect Hepatitis B yield is expected to begin in March.
"We are pleased that we continue to make positive regulatory progress toward fully commercializing our PROCLEIX ULTRIO assay on the TIGRIS system in the United States," said Henry L. Nordhoff, Gen-Probe's chairman, president and chief executive officer. "Our goal is to offer customers the capability to intercept three dangerous viruses at once in donated blood, using a fully automated, high-throughput system that maximizes the efficiency of testing and minimizes the potential for human error."
In October, the FDA granted marketing approval for the PROCLEIX ULTRIO assay to run on the Company's semi-automated instrument system. The assay was approved to screen donated blood, plasma, organs and tissue for HIV-1 and hepatitis C virus (HCV) in individual blood donations or in pools of up to 16 blood samples, and to detect the presence of hepatitis B virus (HBV).
However, the PROCLEIX ULTRIO assay was not approved to screen donated blood for HBV, as the initial pivotal study for the assay was not designed to, and did not, demonstrate yield. Yield is defined as HBV-infected blood donations that were intercepted by the PROCLEIX ULTRIO assay, but that were initially negative based on serology tests for HBV surface antigen and core antibodies. Based on discussions with the FDA, Gen-Probe agreed to conduct a post-marketing study of the PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor-screening claim.
The FDA has recently given Gen-Probe feedback on the draft design of this post-marketing study, and the study is expected to begin in March. The duration of the study will depend on the rate at which HBV yield is identified. Based on the outcome of the study, the Company intends to submit a regulatory application to the FDA seeking a donor-screening claim for HBV for the PROCLEIX ULTRIO assay. As a result, Gen-Probe believes it is likely to earn a $10 million milestone from Chiron, the Company's blood screening partner, in 2008. This milestone is due upon full approval of the PROCLEIX ULTRIO assay on the TIGRIS system in the United States.
Outside the United States, where the PROCLEIX ULTRIO assay has been approved since early 2004, blood bank customers have routinely intercepted HBV-infected donations that otherwise would have been transfused into blood recipients. Recent scientific reports from Europe have documented yield rates as high as approximately one in 50,000 individual donations, a much higher rate than is observed with either HIV-1 or HCV.
Hepatitis B is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. Hepatitis B infection can lead to liver failure, cirrhosis or cancer. According to the World Health Organization, more than 350 million people worldwide are chronically infected with HBV. More than one million people die annually as a result of HBV infections.
The fully automated, high-throughput PROCLEIX TIGRIS system can process 1,000 blood samples in about 14 hours, a level of productivity that facilitates testing in smaller pool sizes, which in turn increases assay sensitivity and increases blood safety. The PROCLEIX TIGRIS system, like the PROCLEIX ULTRIO Assay, is approved for commercial blood screening use in many countries outside the United States.
In addition, many US blood screening customers use the PROCLEIX TIGRIS system to test for the West Nile virus (WNV) under an investigational new drug application. Gen-Probe's regulatory application to test for WNV on the PROCLEIX TIGRIS system is under review by the FDA.
Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics, Inc.
Additional Use for APTIMA Chlamydia Assay
Separately, Gen-Probe announced that the FDA has granted marketing clearance to use the Company's standalone APTIMA(R) assay for Chlamydia trachomatis (CT) to test liquid Pap specimens on the TIGRIS system. The clearance applies to liquid Pap specimens collected in the PreservCyt(R) solution and processed with Cytyc's ThinPrep(R) 2000 System. The APTIMA CT assay previously had been cleared to test other specimen types on the TIGRIS system.
Trademarks
PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS and APTIMA are trademarks of Gen-Probe. PreservCyt and ThinPrep are trademarks of Cytyc Corporation.
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 1,000 people. For more information, go to www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's 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, customer adoption and potential milestone payments 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 the post-marketing study for the PROCLEIX ULTRIO assay will not be successful, (ii) 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, (iii) the risk that we may not earn or receive milestone payments from our collaborators, (iv) the possibility that the market for the sale of our new products, such as our PROCLEIX ULTRIO assay, PROCLEIX West Nile virus assay, PROCLEIX TIGRIS system and APTIMA CT assay, may not develop as expected, (v) we may not be able to compete effectively, (vi) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vii) 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-ProbeCONTACT: Michael Watts, Sr. director, investor relations and corporatecommunications of Gen-Probe, +1-858-410-8673
Web site: http://www.gen-probe.com/
