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Gen-Probe Begins U.S. Clinical Study of Molecular Test for Human Papillomavirus, Which Causes Cervical Cancer
Date:3/31/2008

SAN DIEGO, March 31 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has begun a pivotal U.S. clinical trial of its investigational APTIMA(R) assay to detect human papillomavirus (HPV), which causes cervical cancer.

"Starting this highly complex, multi-center study was an important goal for Gen-Probe in early 2008," said Carl Hull, the Company's president and chief operating officer. "Enrolling our first patient last week is a testament to the hard work of our integrated product development team. We expect that their extensive efforts to date will ultimately result in the introduction of a highly accurate APTIMA HPV assay that improves the detection and treatment of cervical cancer."

The investigational APTIMA HPV assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer. Gen-Probe believes that targeting these mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women who are infected, but HPV infections are common and many resolve without causing cervical cancer.

Women undergoing routine Pap testing at participating U.S. clinics are eligible to participate in the clinical study, which includes two arms. One arm enrolls women whose Pap results are classified as ASC-US (atypical squamous cells of undetermined significance), meaning they are neither normal nor clearly indicative of changes associated with progression to cervical cancer. In t
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SOURCE Gen-Probe Incorporated
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