A team of researchers at the USC Norris Comprehensive Cancer Center developed a test able to discern between cancerous and benign pelvic masses with up to 91% accuracy. The hope is to send the test, known as OvaPrint, to Clinical Laboratory Improvement Amendments testing to launch it commercially within the next year.

Research conceptualization began in 2015 with an aim to use cell-free DNA methylation, a chemical modification of DNA that often occurs during early carcinogenesis, for cancer screening. Bodour Salhia, the research team’s principal investigator and interim chair of translational genomics, wanted to do research on ovarian cancer because she was working in a program with a specific focus on women’s cancer.

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“A sensitive and specific screening test for ovarian cancer is a clinically unmet need for women, it just needs to be done once and for all,” Salhia said.

The new test uses cell-free DNA methylation in liquid biopsy format to aid in early detection and screening for ovarian cancer, which currently does not have early screening options. This means that it is difficult for doctors to determine whether women have a mass during the mass’s early stages.

But the complexity of the issue does not stop there: If a mass was detected, there was still no technology able to adequately identify whether the mass was benign or malignant, unlike with other cancers. The OvaPrint has potential to solve both problems. 

“Knowing [whether a mass is cancerous or benign] is important because you’ll want a gynecological oncologist to treat women who actually have ovarian cancer … so it’s important for treatment management,” Salhia said, adding that the difference also can affect a woman’s preference for timely surgery.

The OvaPrint is designed to detect masses early enough for women to catch ovarian cancer before it becomes more severe, like similar cancer screening tests have since accomplished. Currently, a majority of people go into surgery without being certain about their treatment plan. 

Salhia’s team demonstrated that the OvaPrint could discriminate between healthy individuals and those who presented a mass. Ideally, OvaPrint will be able to see how far in advance you can predict whether someone will develop a mass that is visible on an image. 

Because ovarian cancer is rarely diagnosed, collecting samples for research has posed a large challenge — especially those that reveal stage one masses. Dr. Lynda Roman works to collect these samples for Salhia and her laboratory team.

Ensuring there is a large amount of samples is critical to this research because the scientists involved hope for OvaPrint technology to become commercially available, but obtaining those samples was also one of the hardest parts of the research. 

“Getting samples is really difficult, especially because we focused on samples and our initial study on stage one tumors,” Salhia said. “Those are really hard to find because women are most often not diagnosed at stage one.”

To ensure the test is clinically relevant, its results must be robust enough to be reproducible, scalable, and accurate. Researchers made efforts to ensure the methodology of the study was as robust as possible.

“This isn’t an easy test to do, there’s [no] leeway for errors in processing or test technique,” Roman said regarding the intricacies of the multi-step sample collection process. “And then you also need high numbers … The logistics of trying to get enough specimens [is challenging].”

The OvaPrint team is unique in the way they are using and applying their research, Salhia said. Not everybody is using their research solely for clinical development, and the OvaPrint team sees the use of methylation methodologies as more than a research tool.

“I’m the interim chair of the department of translational genomics,” Salhia said. “This is translational research. It’s not just doing the research and getting a paper and saying it has translational potential, but we’re literally trying to translate our research by making this clinically available.”

For students like Rina Okuda, a sophomore majoring in biochemistry, research like this is inspiring because it empowers women and will help raise awareness of ovarian cancer.

“Most people see women’s voice[s] as over-exaggerating, when women voice their pain, whether that’s physical or mental, they’re just like, ‘you’re overreacting,’” Okuda said. “I feel like women’s disease, it’s just not as high of a priority. Maybe because it affects only half the population.”

Up to 91% accuracy is very impressive, Okuda said, calling it nearly perfect, and she said it was nice to know that there are people who care enough to do the research.

“If I did nothing else in my lifetime but come up with this, like never work again, I will be more than happy to say that I brought ovarian cancer screening tests to the world,” Salhia said. “That would be an amazing accomplishment. I could die happy.”