SAN DIEGO, Feb. 21 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) has submitted to the U.S. Food and Drug Administration (FDA) a supplemental regulatory application for the additional use of the PROCLEIX(R) ULTRIO(R) assay to screen donated blood for the hepatitis B virus (HBV), the Company announced today. The FDA approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006.
The Company is seeking approval to use the assay to screen for HBV on both its semi-automated instrument platform and on the fully automated, high-throughput TIGRIS(R) system.
"Demonstrating that our PROCLEIX ULTRIO assay is able to identify HBV-infected blood donations that serological tests miss and submitting this supplemental Biologics License Application (BLA) to the FDA are major milestones for our blood screening business, and may further safeguard the U.S. donated blood supply," said Hank Nordhoff, Gen-Probe's chairman and chief executive officer.
Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics, Inc.
In October of 2006, the FDA approved the PROCLEIX ULTRIO assay to screen donated blood, plasma, organs and tissue for HIV-1 and HCV on Gen-Probe's semi-automated instrument system. In May of 2007, the FDA granted a similar approval to use the assay on the TIGRIS system.
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 HBV 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 and Chiron agreed to conduct a post-marketing study of the PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor-screening claim.
Gen-Probe began this post-marketing study in early 2007. To date, approximately 500,000 blood donations have been screened in the study, and two HBV yield cases have been identified. Data on these two yield cases comprise the foundation of the Company's supplemental BLA.
HBV is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. HBV 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.
PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a trademark of 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 approximately 25 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 http://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 new products, including the PROCLEIX ULTRIO
assay, 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 assay and 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 Novartis 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
Senior director, investor relations and
|SOURCE Gen-Probe Incorporated|
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