Trovagene Inc., a company that develops technology for the detection and monitoring of cell-free DNA in urine, recently presented clinical data of its urine-based HPV HR Test during the 30th International Human Papillomavirus Conference that took place in Lisbon, Portugal.
The results were presented by Adriana Lorenzi, a research fellow at the Institute of Education and Research and Molecular Oncology Research Center, Barretos Cancer Hospital – Pio XII Foundation, Barretos, Brazil, during an oral session entitled “High-Risk HPV Detection in Urine Samples from a Brazilian Referral Population”.
“These results demonstrate the ability to detect high-risk HPV from precancerous lesions with high sensitivity using a convenient and non-invasive urine sample,” stated Lorenzi. “This test has potential to offer an important option for women who are not currently being screened by traditional methods.”
In the clinical study researchers collected urine samples from women preceding treatment of cervical pre-cancer lesions. The samples were then verified with Trovagene’s HPV HR Test, which detects the presence of HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. The test does not identify which one of the 13 high-risk types is detected and a positive test result may indicate the need for further testing or follow-up as determined by a physician or health care provider.
During the study, results obtained from the test were compared with Roche’s cobas® HPV Test, revealing a consistency with previously reported Predictors 4 results, which have shown Trovagene’s HPV HR Test sensitivity for the detection of CIN2+ and CIN3+ is similar to other screening tests for cervical cancer. In the Brazilian sample, a total of 202 cases of CIN3+ and of 271 cases of CIN2+ disease were examined.
“The results presented here affirm the high sensitivity and robust performance of our urine-based HPV test, which has potential to provide cervical cancer screening to women that are not utilizing traditional testing solutions,” stated Antonius Schuh, Ph.D., chief executive officer of Trovagene. “We look forward to the results from our ongoing general population screening trial, which will complete our clinical data package and support our business development efforts with potential commercial partners.” The clinical data concerning the screening of the general population are expected for the first semester of 2016.
The screening test is being examined in a third study to determine the technology performance to identify women with high HPV risk. The study is being conducted in the general population and since it is a non-invasive method is could be a crucial screening for fighting the high incidence of cervical cancer, a major health problem in underserved regions in Eastern Europe, India, Latin America and China. In these regions, most women do not have access to HPV screening, with estimates indicating that 60% of all cervical cancer cases occur in women who have not been screened for HPV and 87% of the deaths due to cervical cancer happen in medically underserved regions where women to not have access to cervical Pap smears due to cultural and economic reasons.