Gen-Probe's clinical study, which is expected to enroll approximately 800 women at about eight trial sites, is forecast to conclude in the first half of 2010. In the summer of next year, Gen-Probe intends to submit to the U.S. Food and Drug Administration a 510(k) application to enable laboratories to use its APTIMA assay to test for Trichomonas from multiple female specimen types.
As previously disclosed, Gen-Probe expects costs associated with clinical studies for the Company's Trichomonas, human papillomavirus (HPV) and PCA3 tests to contribute to research and development expenses of approximately $30 million in the third quarter of 2009.
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has more than 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,200 people. For more information, go to www.gen-probe.com.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such
|SOURCE Gen-Probe Incorporated|
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