SAN DIEGO, June 7, 2012 /PRNewswire/ -- Trovagene, Inc. (Nasdaq: TROV), a developer of trans-renal molecular diagnostics, and Strand Life Sciences Pvt Ltd., of Bangalore, India, have entered into a Memorandum of Understanding (MOU) to license and validate Trovagene's proprietary Human Papillomavirus (HPV) urine test and High Risk HPV DNA Assay for clinical diagnostic and carrier screening use in India and countries in the South Asian Association for Regional Cooperation ("SAARC").
"The potential to use urine, an easily obtained and stable testing sample, for high risk HPV carrier screening across medically underserved areas is very promising," remarks Vijay Chandru, PhD, chairman and chief executive officer of Strand Life Sciences. "We are pleased to be working with Trovagene, a leader in this field, on this important project that has the potential to make HPV screening broadly available in the region and to become a new standard of care."
Strand intends to establish Trovagene's proprietary HPV assay technology in its molecular diagnostic laboratory operations and to perform extended analytical and clinical validation studies in its target markets. The initial validation will assess the diagnostic accuracy using urine as a specimen for HPV testing in various stages of disease progression, ranging from low grade erosions to established cervical cancer. This will be compared to standard cytology and PAP staining as well as a commercially available standard molecular test for the detection of HPV DNA from cervical smears.
"The concept of carrier screening for high risk HPV status is one that may change the way the risk for cervical cancer and other HPV-related cancers is detected," states Antonius Schuh, Ph.D., chief executive officer of Trovagene. "In the majority of high risk HPV carriers the virus clears spontaneously. These individuals do not need to undergo more invasive diagnostic procedures. A urine test holds the promise to identify individuals free of high-risk HPV in an entirely non-invasive fashion."
Strand also intends to explore and validate the clinical utility of HPV DNA testing as a risk indicator and pathological cause of oral cancer in buccal swabs, biopsies and saliva/sputum specimens.
About Strand Life Sciences Pvt Ltd.
Strand Life Sciences – "Strand" has pioneered the practice of scientific intelligence in life and health sciences. Strand's segue into the life sciences was through products and services for research biologists, chemists, and toxicologists that combine advanced visualization, predictive systems modeling, data integration and scientific context management. Strand was spun off by faculty of the Indian Institute of Science, the first sanctioned example of academic entrepreneurship in India. Strand has a strong portfolio of intellectual property which include products such as GeneSpring, Avadis NGS, the Virtual Liver Platform and several novel biomarkers. Over 2000 research laboratories worldwide (about 30% of global market share) are licensees of Strand's technology products as are several leading Pharmaceutical and Biotechnology companies. Strand's talent pool, of around 150 "best in class" computer scientists and biologists, has repeatedly demonstrated capabilities to define and deliver path breaking products and solutions.
Strand's state-of-the-art Research and Development Center in Bangalore includes a 30,000 square feet informatics facility space in Bangalore has dedicated customer work areas with electronic access systems and exclusive network infrastructure to ensure conformance to the highest level of data and information security. Strand and its partner Ganit Labs share additional 10,000 square feet of laboratory space with state of the art clinical genomics capabilities and capacity for pre-clinical toxicology assays of lead compounds.
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 has a dominant 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 CLL (chronic lymphocytic leukemia) 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.