Strand, Trovagene enter MOU to license and validate HPV assay technology

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.