Trovagene Inc, San Diego, a developer of cell-free molecular diagnostics, has announced the presentation of clinical results from the Predictors 4 trial of the company’s noninvasive, urine-based assay for human papilloma virus (HPV).

Results from the trial demonstrate the high sensitivity of Trovagene’s assay for determining high-risk HPV types and cervical lesions or cervical intraepithelial neoplasia (CIN) grades 2 and 3. The results were presented by Jack Cuzick, PhD, director of the Wolfson Institute of Preventive Medicine and head of the center for cancer prevention at Queen Mary University of London, at the 2015 European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Seville, Spain.

“The ability to reliably detect HPV in a urine sample is an important step for protecting more women against cervix cancer, as this method is likely to be better accepted by women and useable in a wide variety of situations,” says Cuzick. “The performance of the Trovagene test indicates that this is a real possibility, and its widespread implementation in both the developed and developing world would be an important component in controlling this cancer.”

The EUROGIN congress aims to incorporate a full review of current scientific developments in the field of cervical cancer and HPV-related diseases, raising their public health profile and demonstrating the need for responsible health services in this area. The event endeavors to translate scientific and evidence-based research into clinical practice.

In the Predictors 4 trial, urine and cervical samples were collected from 501 women, and data from this large patient subset demonstrated that the sensitivity of Trovagene’s HPV assay for cervical samples was comparable to established cervical screening tests. Sensitivity of the Trovagene HPV assay using cervical samples was 96.3% for CIN 3+ and 94.5% for CIN 2+. Sensitivity for urine samples was 91.4% for CIN 3+ and 89.0% for CIN 2+. Furthermore, detection of high-risk HPV in urine was not different from cervical samples for all age groups of women in the study (18–29, 30–39, and 40–69 years of age).

The study authors concluded that while there is a small loss of sensitivity when using urine samples, the greater than 90% sensitivity for CIN 3+ is still better than conventional Pap cytology. Such high sensitivity makes the Trovagene assay a good candidate to increase adoption of HPV testing, especially for women who are not currently being screened for cervical cancer.

Screening for the detection of high-risk HPV and cervical lesions is critical for reducing the incidence and morbidity of cervical cancer. The incidence of cervical cancer in the United States has declined 75% since the 1950s when widespread implementation of screening began. Still, there are approximately 30 million American women who remain unscreened.


Antonius Schuh, PhD

In less-developed regions such as China, India, and areas of Eastern Europe and Latin America, where a minority of these populations are screened, the incidence of cervical cancer is a major issue. Annually, 87% of the 266,000 cervical cancer deaths occur in these less-developed regions. It is estimated that 60% of cervical cancer cases occur among women who are unscreened, a fact that indicates the strong need for a noninvasive HPV screening assay to expand testing around the world.

“These results highlight the clinical performance of Trovagene’s urine-based HPV assay and demonstrate that our test could be used as an important screening tool, particularly for patients that currently do not receive an annual HPV screening exam,” says Antonius Schuh, PhD, Trovagene CEO. “The test has high sensitivity and robust performance, and due to its noninvasive sample collection, it is ideal for women who are not screened because of the invasive nature of cervical exams or because of the limited access they have to healthcare clinics. Trovagene’s HPV assay has the potential to transform cervical cancer detection in a significant number of countries where this situation exists.”

The Trovagene HPV assay is a laboratory-developed test validated for performance in the company’s CLIA-certified laboratory. For further information, visit Trovagene Inc.