08:00 , Jan 21, 2013 |  BC Week In Review  |  Clinical News

Aptima Trichomonas vaginalis assay regulatory update

FDA approved Hologic's Aptima Trichomonas vaginalis assay for use on its Panther instrument system to detect T. vaginalis infection. In April 2011, FDA approved the amplified nucleic acid test for use on the company's Tigris...
07:00 , Apr 25, 2011 |  BC Week In Review  |  Clinical News

Aptima Trichomonas vaginalis assay regulatory update

FDA granted 510(k) clearance for Gen-Probe's Aptima Trichomonas vaginalis assay to detect T. vaginalis infection. The amplified nucleic acid test runs on the company's Tigris automated system and has CE Mark approval in the EU....
07:00 , Oct 11, 2010 |  BC Week In Review  |  Clinical News

Aptima Trichomonas vaginalis assay regulatory update

Gen-Probe submitted a 510(k) application to FDA for its Aptima Trichomonas vaginalis assay to detect T. vaginalis infection. The test runs on the company's Tigris automated system and already has CE Mark approval in the...
07:00 , Jul 5, 2010 |  BC Week In Review  |  Clinical News

Aptima Trichomonas vaginalis assay regulatory update

Gen-Probe received a CE Mark approval in the EU for its Aptima assay to detect Trichomonas vaginalis infection. The test runs on the company's Tigris automated system. Gen-Probe plans to apply for U.S. approval of...
07:00 , Jul 5, 2010 |  BioCentury  |  Finance

2H10 milestones

2H10 milestones Selected products with Phase III or regulatory milestones expected in 2H10 Company Product Indication Event Milestone Actelion Ltd. (SIX:ATLN) Pivlaz clazosentan Prevent the occurrence...
07:00 , Aug 24, 2009 |  BC Week In Review  |  Clinical News

Aptima Trichomonas vaginalis assay: Pivotal trial started

Gen-Probe began a U.S. pivotal trial to evaluate its Aptima Trichomonas vaginalis assay in about 800 women. Gen-Probe Inc. (NASDAQ:GPRO), San Diego, Calif.   Product: Aptima Trichomonas vaginalis assay   Business: Diagnostic   Molecular target: NA   Description:...