Monday, February 09, 2015 2:49:34 PM
• Based on data generated from 501 women who donated urine and cervical samples, Trovagene's (TROV +2%) HPV assay performed on cervical samples demonstrated sensitivity of 96.3% for cervical intraepithelial neoplasia (CIN) Grade 3+, the most severe type of dysplasia that has the highest potential to become cervical cancer, when compared to established cervical screening tests. Its sensitivity for CIN Grade 2+ was 94.5%. For tests performed on urine samples, the sensitivity for CIN 3+ was 91.4% and 89.0% for CIN 2+ when compared to established cervical screening tests. Results for CIN 1+ and specificity were not reported. It also does not appear that the study was powered for statistical significance.
• Investigators believe that the loss of sensitivity with urine samples is still better that PAP smears while the added convenience of urine sampling may increase adoption of HPV testing.
"..does not appear that the study was powered for statistical significance."
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