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Gen-Probe Reports Strong Financial Results for First Quarter 2008, Raises Full-Year Guidance
Date:4/28/2008

Food and Drug Administration (FDA) a supplemental regulatory

application for the additional use of the PROCLEIX ULTRIO assay to

screen donated blood for hepatitis B virus (HBV). The FDA approved the

assay to screen donated blood for HIV-1 and hepatitis C virus in late

2006. The Company is seeking approval to use the assay to screen for

HBV on both its semi-automated instrument platform and on the fully

automated, high-throughput TIGRIS system.

-- HPV Clinical Trial Begins. On March 31, Gen-Probe announced that the

Company had begun a pivotal U.S. clinical trial of its investigational

APTIMA assay to detect HPV, which causes cervical cancer. The

investigational APTIMA HPV assay is an amplified nucleic acid test that

is designed to detect 14 high-risk HPV types that are associated with

cervical cancer. More specifically, the assay is designed to detect two

messenger RNAs (mRNAs), E6 and E7, which are produced in higher amounts

when HPV infections progress toward cervical cancer. Gen-Probe expects

to enroll approximately 7,000 women in the study. Actual enrollment,

however, may vary based on the prevalence of cervical disease among

women in the trial. The trial enrollment and testing are expected to

take approximately two years.

-- Two PCA3 Studies Published. The leading peer-reviewed Journal of

Urology(R) published two important articles that the Company believes

illustrate the value of Gen-Probe's prostate cancer marker PCA3. In

the first article, "PCA3: A Molecular Urine Assay for Predicting

Prostate Biopsy Outcome" (Volume 179, Issue 4, Pages 1587-1592,

April 2008), researchers from the Urological Sciences Research

Foundation, The Johns Hopkins University, the University of Washington,

DiagnoCure and Gen-Probe conclude that PCA3 is
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SOURCE Gen-Probe Incorporated
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