Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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)

You may also be interested in...

Digene Fights Antitrust Charges As Part Of HPV Diagnostics Patent Case

Human papillomavirus test maker Digene, recently acquired by Qiagen, is defending itself against allegations of anti-competitive business practices from Third Wave Technologies as part of a larger patent battle between the firms

Third Wave Technologies’ HPV tests

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)...

Dissecting The Impact: Chi-Med Details Coronavirus Experience

CEO breaks down to Scrip how the Hong Kong-based company managed its way through the coronavirus outbreak in China, saying improvisation was critical. 




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts