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Third Wave Technologies’ HPV tests

This article was originally published in The Gray Sheet

Executive Summary

Firm commences clinical trials of two human papillomavirus (HPV) tests, for which it expects to apply to FDA for marketing go-ahead in 2007. The products include a screening test to detect the presence of 14 high-risk types of HPV and a genotyping test to detect HPV types 16 and 18. HPV types 16 and 18 are responsible for about 70% of cervical cancer cases, Third Wave says. The firm and competitor Digene recently agreed to forego patent litigation against each other for one year (1"The Gray Sheet" April 17, 2006, p. 18)...

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Third Wave HPV test approved in Europe

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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Digene's direct-to-consumer advertising campaign persuaded consumers and investors that its HPV Test is the standard of care for cervical cancer screening, driving the firm's stock up 34% to close the first quarter at $39.10

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