Strand Life Sciences to validate and commercialize Trovagene's urine-based HPV test

Trovagene, Inc. (NASDAQ: TROV) and Strand Life Sciences Pvt Ltd., of Bangalore, India, completed their agreement to validate and commercialize Trovagene's proprietary urine-based Human Papillomavirus (HPV) test for clinical diagnostic and carrier screening use. Trovagene's urine-based HPV test is designed to allow for completely non-invasive HPV carrier screening. Strand's initial target market is an estimated population of over 450 million women between the ages 18 and 65 in India and South Asia.  

HPV infection is the leading cause of cervical cancer. In India, cervical cancer is the leading cause of cancer related mortality in women. The incidence and death rate from cervical cancer are five times higher than in the US. The total cost of secondary treatment for cervical cancer is the highest of all chronic conditions, placing a significant burden on the Indian healthcare system. 

"We are excited to work with Strand to validate and launch our proprietary HPV test in India and South Asia. Improved logistics, reduced costs and increased compliance can significantly increase HPV screening rates," states Antonius Schuh, Ph.D., chief executive officer of Trovagene. "This is the first milestone in our commercial strategy to make our HPV test available in key healthcare markets globally."

The accuracy of Trovagene's urine-based HPV test was demonstrated in a 320 patient study comparing Trovagene's test with a widely used competitive test that is based on a traditional cervical scraping sample. Trovagene's HPV test was found to have an analytical sensitivity and specificity of 93% and 96%, respectively, for the detection of high risk HPV strains vs. 78% and 86% for the competitive test. 

"We have completed transfer of the test protocol and reagents and have initiated analytical validation in our labs," says Vijay Chandru, Ph.D., chairman and chief executive officer of Strand Life Sciences. "We intend to conduct a very thorough clinical validation program in our target population and launch a robust and well validated test. We are partnering with leading public health experts in women's health and will follow best practices in these programs.This test can 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 India and South Asia."

SOURCE Trovagene, Inc.