Trovagene, Inc. (NASDAQ: TROV), today announced the commercial availability of its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test. The non-invasive test is designed to accurately identify the presence or absence of 15 known high-risk HPV strains using proprietary DNA sequences.
Approximately 20 million Americans carry HPV, with six million new cases occurring every year, according to the Centers for Disease Control and Prevention. By the age of 50, 80 percent of all women will have had exposure to HPV at some point in their lives. In 2012, the US Preventative Task Force recommended HPV DNA testing as a mandatory part of the cervical cancer screening guidelines to help diagnose a greater number of women and thereby reduce the risk of developing cervical cancer. Currently, less than 40 percent of women undergo HPV DNA testing in conjunction with a standard Pap smear or liquid cytology sample.
The Trovagene HPV-HR DNA test is a non-invasive option that may improve the adoption and acceptance rate of HPV testing. Carrier testing for HPV can help raise awareness and encourage use of preventative measures to reduce transmission of the virus. For women who wish to avoid repeated physical exams, but still need monitoring for their HPV status, a urine-based HPV-HR DNA test can facilitate more comprehensive patient monitoring.
"The launch of our urine-based HPV-HR DNA test represents an important milestone for Trovagene," said Antonius Schuh, Ph.D., chief executive officer. "Non-invasive carrier testing may help to increase awareness of HPV status and could reduce the incidence of HPV-related cervical cancer and other cancers worldwide."