- Company Submits Application to Run Triplex Blood Screening Test on
Fully Automated System in U.S., Expects to Begin Post-Marketing Yield Study in
March -
- Separately, Gen-Probe Receives FDA Marketing Clearance to Test Liquid
Pap Specimens for Chlamydia Using Standalone APTIMA(R) Assay on the TIGRIS
System -
SAN DIEGO, Jan. 29 /PRNewswire-FirstCall/ -- Gen-Probe (Nasdaq: GPRO)
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
SOURCE Gen-Probe
01/29/2007
CONTACT: Michael Watts, Sr. director, investor relations and corporate
communications of Gen-Probe, +1-858-410-8673
Web site: http://www.gen-probe.com
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