Trovagene and Barretos Cancer Hospital, Brazil, to Evaluate Urine-Based HPV Assay as Potential Pap Smear Replacement

SAN DIEGO, Calif., Nov. 27, 2012 /PRNewswire/ -- Trovagene, Inc. (NASDAQ:  TROV) and the PIO XII Foundation, affiliated with Brazil's Barretos Cancer Hospital, today announced that they entered into a research collaboration to evaluate the performance of a urine-based molecular assay for detection of HPV types associated with cervical lesions. The goal of the study is to determine whether this assay can potentially replace Pap smears as the primary screen for cervical cancer risk in Brazil's healthcare system. Barretos Cancer Hospital, Brazil's preeminent center for oncology research and cancer treatment, will conduct the study using Trovagene's proprietary, urine-based method for determining the presence of high risk HPV types, allowing for completely non-invasive HPV carrier screening.  

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HPV infections are the leading cause of cervical cancer. In medically underserved regions, traditional screening methods to detect elevated risk of cervical cancer, such as a Pap smear, are not broadly available. In Brazil, cervical cancer is the second most frequent tumor type in women and the leading cause of cancer-related mortality in women 14 to 44 years of age. Brazil has placed special emphasis on programs to improve HPV screening to address this pressing healthcare need.

"We are excited to begin this important clinical trial using Trovagene's proprietary urine-based HPV assay," says Adhemar Longatto Filho, M.Sc., Ph.D., PMIAC, from the Laboratory of Medical Investigation at the University of Sao Paulo and principal investigator for the study at Barretos Cancer Hospital. "This study can pave the way to make HPV screening broadly available to medically underserved patients in our region. Our goal is to provide patients with non-invasive testing options to determine their HPV risk factor and significantly improve women's healthcare in Brazil."

"We are committed to work with Barretos Cancer Hospital to study the performance of our proprietary HPV assay in Brazil. Improved logistics, reduced costs and increased compliance can significantly increase HPV screening rates and save lives," states Antonius Schuh, Ph.D., chief executive officer of Trovagene. "This collaboration with Barretos is another important step towards making Trovagene's non-invasive HPV carrier screen available in key healthcare markets globally."

About PIO XII Foundation and Barretos Cancer Hospital.

PIO XII Foundation and Barretos Cancer Hospital – Barretos Cancer Hospital has become the most important center of oncology research in Brazil. Barretos Cancer Hospital provides patients with free treatments, including chemotherapy, radiology, radiotherapy, surgeries, exams, and biopsies. Over 3,000 patients are treated daily, serving over 1,200 cities.

About Trovagene, Inc.

Headquartered in San Diego, California, Trovagene is developing its patented technology for the detection of transrenal DNA and RNA, short nucleic acid fragments, originating from normal and diseased cell death that cross the kidney barrier and can be detected in urine.  Trovagene is leveraging its intellectual property in oncogene mutations via out-licensing and use of its transrenal technologies to extend oncogene mutation detection using urine as a sample.  As a non-invasive and abundant sample, urine may overcome many of the cost and collection challenges associated with biopsy, as well as the volume limitations of blood.

Trovagene has a strong patent position as it relates to transrenal molecular testing. 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. In addition, it owns worldwide rights to nucleophosmin-1 (NPM1), an informative biomarker for acute myeloid leukemia (AML) and mutations in the SF3B1 gene, which have been shown to be associated with chemotherapy response in chronic lymphocytic leukemia (CLL) patients.

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; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third 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, 2011 and other periodic reports filed with the Securities and Exchange Commission.

SOURCE Trovagene, Inc.