Gen-Probe Receives FDA Approval -- Stock
Has Risen 211% (continued)
The TIGRIS System is intended for eventual
use in blood screening laboratories. In December, Gen-Probe
filed an amended Investigational New Drug application with
the FDA to initiate clinical trials of the Procleix® Ultrioä
Assay on the TIGRIS System. The Ultrio Assay will simultaneously
detect HIV-1, hepatitis C virus and hepatitis B virus in donated
blood, plasma, organs and tissue. Gen-Probe intends to begin
clinical trials of the assay on the TIGRIS System in January.
About Gen-Probe Incorporated
Gen-Probe Incorporated, founded in 1983,
is a global leader in the development, manufacture and marketing
of rapid, accurate and cost-effective nucleic acid testing
(NAT) products used for the clinical diagnosis of human diseases
and for screening donated human blood. Using its patented
NAT technology, Gen-Probe has received FDA approvals or clearances
for more than 60 products that detect a wide variety of infectious
microorganisms, including those causing sexually transmitted
diseases, tuberculosis, strep throat, pneumonia and fungal
infections. Additionally, the Company developed and manufactures
the first FDA-approved blood screening assay for the simultaneous
detection of HIV-1 and HCV, which is marketed by Chiron Corporation
as the Procleix® System. Gen-Probe has 20 years of nucleic
acid detection research and product development experience,
and its products are used daily in clinical laboratories and
blood collection centers throughout the world. Gen-Probe is
headquartered in San Diego, California and has approximately
700 employees. Additional information about the Company can
be found on the Internet at www.gen-probe.com.
TIGRIS, APTIMA, DTS and Ultrio are trademarks
of Gen-Probe Incorporated
Procleix is a trademark of Chiron Corporation
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
our goals for the TIGRIS System, 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 any
results, levels of activity, performance or achievements 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 possibility that the market for the sale of our
new products, such as our TIGRIS System, may not develop as
expected, (ii) the enhancement of existing products and the
development of new products may not proceed as planned, (iii)
we may not be able to attract and retain key employees, (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, (vi) we may not be
able to generate market acceptance of our TIGRIS instrument,
(vii) we are dependent on Chiron Corporation and other third
parties for the distribution of some of our products, (viii)
we are dependent on a small number of customers, contract
manufacturers and single source suppliers of raw materials,
(ix) changes in third-party reimbursement policies regarding
our products could adversely affect sales of our products,
(x) changes in government regulation affecting our diagnostic
products could harm our sales and increase our development
costs, and (xi) our involvement in patent and other intellectual
property 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 information about risks and uncertainties we face and
a discussion of our financial statements and footnotes, see
documents we have filed with the SEC, including the Form 10-Q
for the quarter ended September 30, 2003, and all subsequent
periodic fillings made with the SEC. 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 press release or to reflect the occurrence of unanticipated
events.
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