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HPV tests achieve trial endpoints

This article was originally published in The Gray Sheet

Executive Summary

Third Wave Technologies plans to submit to FDA in April clinical trial results for its high-risk human papillomavirus (HPV) test and 16/18 genotyping HPV test, the firm says. The trial achieved all primary clinical endpoints, including a negative predictive value (probability that there is no cervical disease in a patient with atypical or ASCUS Pap test results and negative HPV test results) greater than the study's 99% goal for the "14-type" high-risk HPV test, the company announced March 11. The test is intended to be used in combination with a Pap test in women 30 and over to detect the presence of high-risk HPV types and to guide treatment. The HPV genotyping test, which tests for the presence of HPV types 16 and 18 (which cause roughly 70% of cervical disease) also met its clinical endpoint in the trial. While Qiagen/Digene offers the only FDA-approved molecular assay for HPV (Hybrid Capture 2), Third Wave estimates the global market is $250 million, with $1 billion potential
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