Trovagene, Inc. has initiated development of a diagnostic test to determine the presence of high risk Human Papilloma Virus (HPV) subtypes from urine specimens. The proprietary test (U.S. patent application pending) might, once available, be particularly useful for the determination of carrier status in males.
The company's HPV detection assay is a unique, proprietary method that preferentially amplifies a specific region of the HPV genome of high risk HPV types, but not of low risk types. In an explorative validation study the company has compared the analytical performance of its assay, which uses urine as the sample, to a commercially available HPV test, which uses cytology samples and was performed according to the manufacturer's protocol. Discordant results were resolved by Sanger DNA sequencing. The results showed that the Trovagene assay performed with a sensitivity of 93% and a specificity of 96%, whereas the commercially available LBC test had a sensitivity of 78% and a specificity of 86%.
Trovagene's HPV assay is compatible with the throughput and reliability requirements of a clinical-diagnostic laboratory at very competitive cost levels. The company believes that the detection of high risk HPV types through its urine-based assay could have valuable clinical utility for monitoring the high risk HPV carrier status of an individual. Such infections can lead to cervical cancer, head and neck cancer, and other cancers.
Trovagene plans to begin offering the test in 2012.