NEW YORK (GenomeWeb News) – Third Wave Technologies said today that it has submitted to the US Food and Drug Administration applications for clearance of two molecular tests for human papillomavirus.
The Madison, Wis.-based firm submitted data from trials on its 14-type high-risk HPV and 16/18 genotyping tests. The submissions come after last month’s announcement that the clinical trials on the two tests met their primary endpoints.
Third Wave intends to have an instrument on the market next year for the HPV tests, it said in a statement.
Third Wave said the global HPV testing market is projected to be $250 million in 2008. But the firm, and Qiagen, which sells the only FDA-cleared molecular test for HPV, believe the market is highly underpenetrated and could be valued at around $1 billion.