Beating breast cancer in Africa

In the United States, 90% of patients diagnosed with stage I breast cancer will survive at least five years beyond diagnosis. But in other parts of the world, survival rates are alarmingly lower; for example, in Uganda, about half of all breast cancer patients die within the same time frame.

The gold standard for breast cancer diagnosis in the U.S. and other high-income countries is a core needle biopsy. However, this procedure is generally resource-intensive, making it impractical for widespread use in areas where access to healthcare services is limited. Patients in Sub-Saharan Africa instead undergo a fine needle aspiration (FNA) biopsy, where a clinician manually inserts a needle and rapidly moves it up and down to collect cellular fluid for testing.

Through a meld of medicine and engineering, two student-led teams in the Johns Hopkins Department of Biomedical Engineering and the Center for Bioengineering Innovation & Design (CBID) are working on automating FNA methods to bridge diagnostic gaps in Sub-Saharan Africa. And though they are tackling this global health challenge from different angles, the teams share a common goal of introducing new technology to find breast cancers with greater accuracy, helping patients get timely treatment.

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A better sample on the first try

CBID graduate students Rida Amjed, Sainkhuu Enkh-Otgon, Shirley Lin, Oriol Cuxart Pérez, and Fujia Zheng each hail from a different country – India, Mongolia, the United States, Spain, and China  – and believe their unique backgrounds have helped the team to innovate on a global scale.

“Coming from different cultures and those perspectives has given us a leg up when it comes to navigating foreign health systems and the medtech market. We’re better able to work through cultural nuances, and we’ve had successful stakeholder engagement from the beginning,” said Enkh-Otgon.

Last August, the team spent a month working in both Uganda and Kenya, surveying and assessing the greatest unmet needs in the healthcare systems there, and speaking with patients, survivors, pathologists, surgeons, radiologists, and government agencies.

Any delays in diagnosis or treatment can have a significant impact on survival rates. The team learned that because today’s FNA biopsies have a high inadequacy rate—meaning they don’t capture enough cells for testing —many women must return for repeat biopsies to obtain a definitive diagnosis.

“That’s a significant burden for a patient population who primarily lives in rural and remote regions. It can take women an entire day to travel to a clinic, meaning they take time off work and leave their families behind. Often, they have to sell livestock or some part of their livelihood to even afford the travel and the housing at the center,” said Lin.

With these parameters in mind, the team is developing a new accessory for existing FNA equipment: an instrument designed to dislodge cells from tissue in a way that yields more cells. The automated device, called YieldEASE, will let the clinicians do just one “pass” with the needle to get a good sample, instead of multiple passes as is common now. “With more passes, there is more bleeding and tissue damage. Our device aims to get it right with the first pass, so the procedure is less traumatic for the patients,” said Amjed.

The device also won’t require sterilization and will be reusable, making it a more sustainable option for the team’s target market. And while the CBID project is focused on finding cancer more quickly in Uganda and Kenya, the applications are not limited to one crisis or region. The larger goal is to make this device available in other areas struggling with diagnostic roadblocks, said Enkh-Otgon. The team is actively raising funds to move into the next phase of testing their prototype.

“This project has been more than just an academic experience. Going to these countries and getting to hear all their stories and understanding the barriers to high-quality care first-hand was really enlightening,” said Lin.

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Making biopsies easier to perform

Performing FNA successfully not only takes extensive practice to master but the technique also results in high false negative rates—and worse survival outcomes—for patients in Uganda.

Using connections forged through the CBID team, the undergraduate Design team AutoAspira focused on developing a product to make FNA more reliable, less expensive, and easier for medical staff to master and perform with less training.

“In Uganda, the false negative rate of breast fine needle aspiration can be as high as 26.5%, which means about one in four women who have breast cancer will be sent home thinking they don’t have cancer, resulting in delayed treatment,” said Peggy Li, co-leader of AutoAspira. “After researching the statistics and talking to a variety of experts, we understood that this is a heartbreaking, urgent problem and saw the need to develop better options for performing breast cancer diagnosis in these areas.”

To overcome these limitations, the Hopkins team’s device will automate the fine needle aspiration process to obtain more cells from the lesion than harvested by manual processes. This larger sample will allow the pathologist to make a more accurate diagnosis and decrease the chance of a false negative. Automating this procedure can increase its availability in Uganda by enabling more people to perform it, said co-leader Neha Chellu.

One of the challenges the team faced was finding the right testing models to validate their prototype design.

“Ultimately, we discovered there was not a perfect test model that could identically replicate the clinical condition, but multiple smaller models gave us different pieces of information that were all very valuable for the development of our prototype,” said Li.

The team’s experience on this project has inspired its members to keep working on impactful solutions to global health problems.

“From understanding the patient experience and diagnostic landscape in Uganda to the more hands-on challenges we’ve faced with the testing models and our prototypes, our team has been able to come up with solutions creatively and collaboratively to every problem we’ve encountered so far. I’m really excited to keep working on this project with my team in the future,” said Chellu.

The AutoAspira team also includes Sangmita Singh, Ishir Sharma, Moonhyung (Bruce) Lee, Derek Minn, Hassan Farah, and Shreya Tiwari. Faculty mentors for the project are Elizabeth Logsdon, director of the BME Design programs; Youseph Yazdi, executive director of CBID; and Emily Ambinder, assistant professor of radiology and radiological science.