UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 3, 2006
Gen-Probe Incorporated
(Exact Name of Registrant as Specified in Charter)
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| Delaware
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001-31279
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33-0044608 |
(State or Other Jurisdiction of
Incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.) |
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10210 Genetic Center Drive
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San Diego, CA
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92121 |
(Address of Principal Executive Offices)
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(Zip Code) |
(858) 410-8000
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
Item 8.01 Other Events.
On October 4, 2006, Gen-Probe Incorporated (the “Company”) issued a press release announcing
that the U.S. Food and Drug Administration (“FDA”) has granted marketing approval for the
PROCLEIX® ULTRIO® Assay to run on the enhanced Semi-Automated
PROCLEIX® System. The PROCLEIX ULTRIO 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 initial pivotal study for the PROCLEIX ULTRIO Assay was not designed to, and did not,
demonstrate yield, defined as HBV-infected blood donations that are negative based on serology
tests for HBV surface antigen and core antibody. Based on discussions with the FDA, Gen-Probe and
Chiron, Gen-Probe’s blood screening partner, will initiate a post-marketing study to demonstrate
HBV yield and gain a donor-screening claim. The companies expect this study to begin in early
2007 as the commercial Assay becomes available.
The Company’s press release with respect to this matter is furnished as Exhibit 99.1 to this
Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) The
following exhibit is furnished with this Current Report:
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99.1 |
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Press Release of Gen-Probe Incorporated dated October 4, 2006 |
Forward-Looking Statements
Any statements in this Current Report 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
results of future R&D studies 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 will not be cleared for marketing in the timeframes we expect, if at all, (ii) the
possibility that the market for the sale of our new products, such as our PROCLEIX ULTRIO assay and
TIGRIS system, may not develop as expected, (iii) the risk that additional studies will not
demonstrate HBV yield or otherwise achieve the desired results, (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 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.