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Clinical Results Presented for Trovagene's Urine-Based High-Risk HPV Assay.
Date:8/25/2014

pel Hill.  A total of 37 women referred to a colposcopy clinic due to abnormal cervical cell cytology or persistent HPV infections were evaluated.  The detection rate of high-risk HPV from a urine sample by Trovagene's HR-HPV assay was not affected by the time of day when the urine sample was collected, or whether an initial versus mid-stream urine sample was used.  Additionally, this study showed that women preferred providing a urine sample over brush self-collection of a cervical sample for HPV testing.  Urine samples are clinically practical and preferred.  Finally, a comparison of patient-matched urine samples versus cervical samples for the identification of high-risk HPV positive women with CIN2/3 found that the Trovagene HR-HPV assay, when using a urine sample, was comparable to traditional HPV testing of cervical samples using a commercially available kit.

"Trovagene's urine-based high-risk HPV assay showed high sensitivity for the detection of high-grade cervical lesions among this group of colposcopy patients from North Carolina," said principal investigator Jennifer Smith, PhD, MPH, University of North Carolina at Chapel Hill. "Given women's stated preference for urine-based sampling, these results are encouraging for larger validation studies to be conducted in non-colposcopy populations, particularly because urine-based sampling is likely to reduce both logistical and acceptability barriers when screening hard-to-reach populations."

"The positive study results presented at the IPV Conference are very encouraging as we continue to conduct clinical studies to evaluate the performance of our urine-based high-risk HPV assay as a viable alternative to conventional HPV testing from a cervical specimen," stated Mark Erlander, Ph.D., chief scientific officer of Trovagene.  "A significantly larger, blinded study which compar
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SOURCE Trovagene, Inc.
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