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Promising Clinical Data on Gen-Probe's APTIMA(R) HPV Test Presented at Major European Medical Meeting
Date:11/21/2008

SAN DIEGO, Nov. 21 /PRNewswire-FirstCall/ -- Gen-Probe's (Nasdaq: GPRO) CE-marked APTIMA(R) HPV assay may be an important new molecular tool to more accurately detect high-risk human papillomavirus (HPV) infections that are associated with cervical cancer or precancerous lesions, according to nine oral presentations and two scientific posters presented last week by independent and Gen-Probe researchers at the international conference of the European Research Organization on Genital Infection and Neoplasia (EUROGIN) in Nice, France.

Gen-Probe's APTIMA HPV assay has been CE-marked for sale in the European Union, and clinical trials of the test are underway in the United States. The assay has not been approved for marketing by the U.S. Food and Drug Administration.

"As a whole, these studies suggest that our new APTIMA HPV assay may detect high-risk HPV infections that have progressed, or are progressing, to cervical cancer more specifically than competing assays that simply detect whether HPV infection is present," said Dan Kacian, Ph.D., M.D., Gen-Probe's executive vice president and chief scientist. "Since most HPV infections resolve without causing cancer, more specific tests are needed to avoid unnecessary and invasive medical procedures and patient anxiety. Additional longer-term studies are needed and are underway, but these results give us continued confidence that our test may play an important role in helping protect women from both cervical cancer and the adverse effects of non- specific diagnosis."

In one key presentation at EUROGIN, Joseph Monsonego, M.D., EUROGIN scientific director, presented interim results of the French APTIMA HPV Screening Evaluation (FASE) study from 1,528 women. The study eventually will include 5,000 women between the ages of 20 and 65. In the study, liquid cytolog
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