Clinical Results Presented For TrovaGene, Inc.'s Urine-Based High-Risk HPV Assay

SEATTLE, Aug. 25, 2014 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that results from two independent clinical studies were presented at the 29th International Papillomavirus (IPV) Conference. Results from both pilot studies consistently demonstrated that the Company’s urine-based assay for the detection of high-risk HPV had high sensitivity (greater than 90%) for identifying women with high grade cervical intraepithelial neoplasia (CIN2/3). Assay performance was comparable to traditional HPV testing with commercially available tests in patient-matched cervical samples. In one of these studies, urine collection has been examined to establish standardization of urine as a clinical specimen for high-risk HPV testing.

In an oral presentation entitled “Evaluation of Two Urine-Based HPV Assays In Comparison to Cervical HPV Detection and High-Grade CIN Among Women Attending a Colposcopy Clinic,” results from a population-based National Cancer Institute study, conducted at the University of Oklahoma Health Sciences Center, were released. A total of 72 women with abnormal cervical cancer screening results were referred to a colposcopy clinic. Urine samples had been collected from each patient prior to undergoing a pelvic exam to obtain a cervical sample. In urine samples, Trovagene’s HR-HPV assay was superior to a commercially available HPV test for the identification of high-risk HPV positive women with CIN2/3. When comparing patient-matched urine samples with cervical specimens for the identification of high-risk HPV positive women with CIN2/3, Trovagene’s HR-HPV assay was comparable to traditional HPV testing from cervical specimens.

A second presentation entitled “A Comparison of Urine Collection Times for the Detection of High-Risk HPV Infection in Women” included results from a study conducted at University of North Carolina, Chapel 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 compares sensitivity of detecting high-risk HPV in patients with CIN2/3 in urine versus cervical samples is ongoing and results will be reported by Q1 2015.”

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is leveraging its patented technology for the detection of cell-free DNA, short nucleic acid fragments originating from normal and diseased cell death that can be isolated and detected from urine. Trovagene has a strong intellectual property asset as it relates to cell-free DNA testing in urine. It has U.S. and European patent applications and issued patents that cover testing for HPV and other infectious diseases, cancer, transplantation, prenatal and genetic testing.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any medical diagnostic tests under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2013 and other periodic reports filed with the Securities and Exchange Commission.

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