First, some facts from the World Health Organization: In women worldwide, cervical cancer is the second most common form of cancer, and the second leading cause of cancer-related death in less developed countries; 84 percent of cases occur in lower-income countries; cervical cancer is caused by infection with certain types of human papilloma virus (HPV); and early detection can significantly increase odds for successful treatment and reduce mortality.

But there is currently no low-cost and non-invasive detection system available for women worldwide. Bioengineering seniors Eva Bouzos, Ivy Fernandes, and Marina Predovic are working to change that last fact by designing CERVIS: Cervical cancer Early Response Visual Identification System, a device that detects stage 0 and stage 1 cervical biomarkers in urine. Their goal is to create a paper microfluidic device prototype, similar to an at-home pregnancy test.

“Our first step was to determine if this actually is a problem in the developing world, what percentage of women have HPV, and where we might make an impact,” said Predovic. They enlisted the help of three public health students to perform population-based research. “Having this information helped them put on a different lens—one that we are not able to address in technical classes,” said Bioengineering Associate Professor Prashanth Asuri, who advises the team, along with Public Health Science Program Lecturer Michele Parker. “From our collaboration with the public health students,” said Fernandes, “we found that Tanzania would work well as a test site for our product. A lot of the population lives in rural areas with no electricity or running water, but there is infrastructure in place for medical care and they do have big hospitals. You don’t want to tell someone they have cervical cancer if they don’t have access to a doctor. To get started in this region, we are collaborating with The Buturi Project, a nonprofit supporting a community of six poverty-stricken, rural villages in Tanzania.”

Bouzos explained their device will test for biomarkers to detect the presence of HPV or cancer. “These biomarkers were specifically chosen to be able to distinguish early stage cancer,” she said. “The unique thing about the diagnostics of our project is that it distinguishes between HPV, general cancer, and cervical cancer. HPV can be present for years without progressing.  Sometimes it goes away on its own, but in some cases it leads to cancer. When that happens, the HPV goes away, so the device needs to test for all these biomarkers.  Ideally, our device will alert women of an HPV infection so they can perform routine screenings over a period of years to be aware of disease progression if it occurs.”

The team has been validating assays and designing a paper microfluidic device to detect the biomarkers in mock urine. Recently, the project was selected as a Social Impact Pitch at the 15^th Annual Global Health and Innovation Conference at Yale University, the world’s largest and leading global health and social entrepreneurship conference. “Learning from experts in this field helps us continually question our design and what we need to do to have a larger impact,” Predovic said. “The final form of the device will be determined by how it will be deployed, which is still to be decided. It might be that a testing team travels from place to place and visits every year or so, or it could be used in clinics or hospitals. Conversations with The Buturi Project and with medical professionals in Tanzania will lead to the best solution for the people of Buturi.”

Though the final design is to be determined, the team is dead set on one thing—an education component is a must.  “The device will be supported by information that lays out what HPV is, how you get it, what cervical cancer is, how the two are related, what steps to take if you have either one, and the benefits of routine screening,” said Bouzos. Fernandes added, “We have to educate people on the need for testing and determine the best way to connect people from testing to further help.  Our goal is to develop a clear pipeline from education and outreach to diagnosis to treatment.”

“What impresses me about this team is that they are truly developing a solution and not just a product,” said Asuri, who is also director of SCU’s BioInnovation and Design Laboratory. “Often, entrepreneurs focus on creating a fancy device with all the bells and whistles and describe it with buzzwords to make a splash. This team is working very hard to truly understand customer needs and empathize with the user. This is design thinking at play, and their work exemplifies their appetite to continue to learn and iterate from a human-centered perspective to deployment.”

Fernandes shook off the compliments with a shrug, “It’s the SCU Jesuit mindset,” she said.