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news.Gen-Probe has started a pivotal US clinical trial of its investigational Aptima assay to detect human papillomavirus, which causes cervical cancer.
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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. The Aptima human papillomavirus (HPV) assay is designed to run on Gen-Probe’s fully automated, high-throughput Tigris instrument system, and on the company’s current and future medium-throughput instrument platforms.
Separately, Gen-Probe remains on track to introduce its Aptima HPV assay as a CE-marked product in Europe in the second half of 2008.
Carl Hull, Gen-Probe’s president and COO, said: “Starting this highly complex, multi-center study was an important goal for Gen-Probe in early 2008. Enrolling our first patient last week is a testament to the hard work of our integrated product development team.”