SAN DIEGO – Trovagene, Inc., a developer of transrenal molecular diagnostics, is planning to develop and launch a urine-based Human Papillomavirus (HPV) carrier test to detect the highly-prevalent but lesser-publicized virus in males.
While the virus is widely known for causing cervical cancer in women, little attention has been placed on the medical radar screen to detecting the multiple types of HPV in males. This disparity exists despite the knowledge that HPV is highly prevalent in men and can lead to various types of cancers as well as genital warts. An estimated 6.2 million persons in the United States are newly infected every year, according to a researchers report by epidemiologist Anna Giuliano of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL. Her report said HPV infection is highly-prevalent in sexually active men.
“This is one of the quiet, unaddressed medical needs in the country,” Trovagene CEO Antonius Schuh told the recent 14th annual Rodman & Renshaw Healthcare Conference in New York City.
“Whenever a woman receives from her OB-GYN the news that the histology result was concerning and that therefore an HPV test was performed and she tested positive for a high-risk HPV strain, the unasked question is, what about my partner?”said Schuh.
“And there is today no acceptable sample procedure for that. How do you sample HPV testing from a male? It’s just not happening. But you can do it from urine, and that is where we are going as well.” Schuh said Trovagene (NASDAQ: TROV) will launch a urine-based HPV carrier test for women by the end of 2012, and then later work to “expand” that test to potentially cover male carriers.
The company is currently developing clinical studies in order to validate the male version of this test, which will be offered through its CLIA laboratory once available.
The CEO’s presentation to the healthcare conference is available through the investor relations page at www.trovagene.com.
The planned HPV tests follow Trovagene’s recent announcement of the completion of an agreement with Strand Life Sciences Pvt Ltd., of Bangalore, India to validate and commercialize Trovagene’s proprietary urine-based, non-invasive HPV test for clinical diagnostic and carrier screening use. 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.
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