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): May 23, 2007
Gen-Probe Incorporated
(Exact Name of Registrant as Specified in Charter)
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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 |
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(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 May 24, 2007, Gen-Probe Incorporated (the “Company”) issued a press release announcing that
the U.S. Food and Drug Administration (FDA) has approved the Company’s PROCLEIX®
TIGRIS® system, the first fully automated molecular diagnostics instrument, for use with
the PROCLEIX ULTRIO® assay. The PROCLEIX TIGRIS system was approved with the PROCLEIX
ULTRIO assay 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. The system and assay
also detect hepatitis B virus (HBV) in blood donations that are HBV-positive based on traditional
serology tests for HBV surface antigen and core antibodies. As expected, the system and assay have
not been approved at this time to screen donated blood for HBV, as the initial clinical studies
were 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 the serology tests. Gen-Probe and Chiron have initiated a post-marketing study to
demonstrate HBV yield and gain the associated donor screening claim.
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.
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(d) |
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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 May 24, 2007. |
Forward-Looking Statements
Any statements in this Current Report 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, clinical trials, potential regulatory approvals and
customer adoption 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
additional claims for the PROCLEIX ULTRIO assay and the PROCLEIX TIGRIS system will not be granted
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 WNV assay and PROCLEIX TIGRIS system, 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