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Third Wave to Submit HPV Study Results to FDA in April; Shares Jump

NEW YORK (GenomeWeb News) – Third Wave Technologies said yesterday after the close of the market that it will submit data from clinical trials on its human papillomavirus molecular diagnostic tests with the US Food and Drug Administration next month.
Investors responded enthusiastically to the news, sending Third Wave's shares up 33 percent to $9.45 in early Wednesday trade on the Nasdaq.
The Madison, Wis.-based firm said that its 14-type high-risk HPV test demonstrated a negative predictive value greater than 99 percent, which was the study’s goal. It said that it would provide further data from the study after its FDA submission.
The high-risk HPV test is intended to be used in combination with a Pap test to evaluate women aged 30 and over for the presence of high-risk HPV types and to guide treatment, said Third Wave.
Third Wave also intends to submit study data for its 16/18 HPV genotyping test, which it said achieved primary clinical endpoints, with the FDA next month. HPV types 16 and 18 have been implicated in 70 percent of cervical disease, according to Third Wave.
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.
Separately this morning, First Analysis Securities upgraded its rating on Third Wave's stock to "overweight" from "equal-weight"

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