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Third Wave HPV test approved in Europe

This article was originally published in The Gray Sheet

Executive Summary

Molecular diagnostic reagent firm Third Wave Technologies gains CE-mark clearance for European marketing of a screening test for 14 high-risk types of human papillomavirus (HPV), paving the way for a commercial launch in January 2008, the firm says Dec. 5. Other pipeline products include a second test to detect HPV types 16 and 18. Third Wave says it expects to spend $12 million to $17.5 million over three years on ongoing clinical trials to support PMA applications for both tests, which were initiated in August 2006 (1"The Gray Sheet" Aug. 14, 2006, In Brief). Third Wave is defending itself against patent infringement claims by HPV test market leader Digene, a subsidiary of Qiagen (2"The Gray Sheet" Oct. 22, 2007, p. 22)

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