Trovagene, Inc. (NASDAQ:TROV), a developer of circulating tumor DNA (ctDNA) molecular diagnostics, announced today that the U.S. Patent and Trademark Office has issued Patent No 9,453,265 entitled “Method for Detection of High Risk Human Papillomavirus.” The patent encompasses directed methods of detecting high-risk HPV infections by identifying mutations in the E1 gene of HPV in the urine of a patient, expanding the intellectual property covering Trovagene’s Precision Cancer MonitoringÒ (PCM) technology. Trovagene now has 91 patents issued and 72 patent applications pending in the U.S. and internationally.
“Issuance of this patent further strengthens Trovagene’s extensive patent portfolio supporting our Precision Cancer Monitoring platform,” said Bill Welch, Chief Executive Officer of Trovagene.
Trovagene is submitting a manuscript this quarter that provides data validating the sensitivity and specificity of its HR-HPV, high-risk human papillomavirus urine test in comparison with the Roche Cobas® HPV test. “The data in this manuscript will show that urine sampling is a viable testing alternative, particularly to access women who do not participate in routine screening programs,” said Mark Erlander, Chief Scientific Officer of Trovagene.
Complementing the recently submitted manuscript, and adding to the body of clinical evidence supporting the sensitivity and specificity of Trovagene’s HR-HPV urine-based test, two abstracts have been accepted for presentation at the HPV 2017 31st International Papillomavirus Conference: The first demonstrates clinical performance in a Chinese screening population and illustrates comparable clinical sensitivity or specificity observed between urine and cervical samples. These results support the utility of urine testing for cervical cancer screening among this population. The second abstract describes the analytical performance of the Trovagene HPV-HR urine test.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary Precision Cancer Monitoring® (PCM) technology for the detection and monitoring of circulating tumor DNA (ctDNA) in urine and blood. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s PCM technology is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.