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): August 13, 2008
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
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(Commission
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(I.R.S. Employer |
| Incorporation)
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File Number)
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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)) |
Item 8.01. Other Events.
On August 13, 2008, Gen-Probe Incorporated (the “Company”) issued a news release announcing
that the U.S. Food and Drug Administration (the “FDA”) has approved the Company’s supplemental
regulatory application to use the PROCLEIX® ULTRIO® assay to screen donated
blood for the hepatitis B virus. The FDA had previously approved the assay to screen donated blood
for HIV-1 and the hepatitis C virus. The assay is now approved to screen donated blood, plasma,
organs and tissue for the three viruses in individual blood donations or in pools of up to 16 blood
samples. The assay may be run on the enhanced semi-automated PROCLEIX system (eSAS) and on the
fully automated, high-throughput PROCLEIX TIGRIS® system. A copy of the Company’s news
release with respect to this matter is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
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| Exhibit Number |
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Description |
99.1
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News release dated August 13, 2008 |