Strand Life Sciences and Trovagene, Inc. have entered into a memorandum of Understanding (MoU) to license and validate the latter’s Human Papillomavirus (HPV) urine test and High Risk HPV DNA assay for clinical diagnostic and carrier screening use in India and South Asian countries.

“The potential to use urine, an easily obtained and stable testing sample, for high risk HPV carrier screening across medically underserved areas is promising. 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,” stated Dr Vijay Chandru, chairman and CEO, Strand Life Sciences.

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 cancers is detected,” states Dr Antonius Schuh, CEO, 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.

Strand has a 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 which is around  30 per cent 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 computer scientists and biologists, have  demonstrated capabilities to define and deliver path breaking products and solutions. Its advanced R&D Centre in Bengaluru spans 30,000 square feet of  informatics facility space in Bangalore with an 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.

Trovagene, Inc. is located at San Diego, California, 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.