YieldEASE: Deskilling cancer biopsies for health equity

Breast cancer is one of the most common cancers around all cancer types, it is also the leading cause of death for women worldwide, the incidence rate in Africa is increasing rapidly with a high mortality rate of ranging from 40-80%  compared to 2.5% in the United States. One of the reasons for high mortality rate is late-stage diagnosis, 60-70% of women are diagnosed at a late stage in African countries, with a predominantly 80% in Uganda.

There are different attributing factors to the late-stage diagnosis, including centralized healthcare system, underdeveloped triage system and delayed diagnosis. Among which, diagnostic delay is due to resource limitation, fear and stigma, access to healthcare and shortage of trained clinicians.

Fine Needle Aspiration is the first line diagnostic method used to diagnose breast cancer in Uganda and Kenya given its minimal invasiveness, high sensitivity and fast turnaround time. However, Fine Needle Aspiration performed in this region has an adequacy rate of at least 50 according to literature research and can go up to 80% in rural areas according to our ethnographic research with over 100 patients and 30 pathologists.

77% of the population in East Africa lives in rural areas, with each patient travelling around 200 km to higher level healthcare centers. During our field trip to Uganda, hundreds of patients journeyed for days to central healthcare centers in Kampala the capital, where they received quality care, even resorting to living in tents outside the hospital.

With an inadequate fine needle aspiration, patients need to travel for long distances to get another FNA procedure, delaying the diagnosis and treatment for 6-11 months, increasing the risk of cancer progression and death. The cost to treat late-stage metastatic breast cancer ( $4986) is around 63 times more expensive than to treat early-stage breast cancer ($78) in Uganda, which increases the burden on healthcare system.

To lessen the heavy burden brought to both patients and healthcare system, we are determined to deskill the procedure to empower clinicians at rural areas, and increase access to care, therefore accelerate diagnosis and treatment for underserved patients.

We've designed an accessory to enhance the current fine needle aspiration procedure, ensuring its success regardless of the clinician's skill level. YieldEASE provides consistent, high-frequency linear movement at the needle tip, facilitating efficient tissue breakdown and achieving an 80% sample adequacy rate[RA1]  in a single pass. Clinicians simply attach the syringe and needle to YieldEASE and perform FNA as usual on the tumor lesion. YieldEASE autonomously executes the necessary movements proven to enhance diagnostic cell collection. Thus, it makes the procedure operator-independent, resulting in more consistent tissue samples and ultimately improving FNA efficiency and accuracy.

Our solution is designed to be used by 23,644 and 59,901 nurses in Uganda and Kenya respectively, in lower healthcare centers like healthcare center level IV (District Health Center in Uganda and Sub-County Hospital in Kenya), which has the highest number among all other healthcare workers. Nurses with basic training can use our device to perform Fine Needle Aspiration as they usually do. We aim to improve the access to the 40 million women in rural area in the two countries.

 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9109011/

YieldEASE has conducted month-long ethnographic studies in Uganda and Kenya to understand the landscape and the problem.

In Uganda, Kenya, and the United States, through over 1,000+ hours of clinical observations with breast surgeons, radiologists, pathologists, nurses, and through extensive interviewing of current patients, survivors, and senior breast cancer researchers, our founding team of MSE and MD students have immersed themselves in the challenges associated with breast cancer diagnosis. We are dedicated and motivated to address these challenges by utilizing our collective 90 years of experience in healthcare, biomedical engineering, medical device design, regulatory and entrepreneurship. We are mentored by a large group of advisors throughout Africa and the United States.

We ourselves from developing countries, we are dedicated to start working for and helping the communities we resonate with. We closely align ourselves with WHO Breast Cancer Initiative.

Recognizing the importance of local engagement and project sustainability, we are committed to harnessing the power of local communities through strategic partnerships. We have established connections with government of Uganda and Kenya, and our collective mentor group from Jhpiego, WHO have a collective social enterprise and public health experience of over 8 decades spanning over 45 countries.

The advisors facilitate our team with established mentor network and support.

We have iteraterd through 3 generations of prototypes with different concepts and we have conducted multiple pre-clinical benchtop studies to validate proof-of-concept with IRB under review to test efficacy in excised tumors and patients undergoing lumpectomy and mastectomy.

We are looking to gain support from technical experts on the mechanical interaction between our needle movement and breast tissue, mentorship from health economic experts on how to establish a sustainable business in Sub-Saharan Africa, advice on evidence generation to prove safety and efficacy, effectiveness. We are also looking for pitch guidance to help us gain funding in global health space.

YieldEASE has integrated the insights from the top FNA clinicians in the world from different geographical regions and clinical specialties. We aim to integrate both the needle movement and cancer region localization which has never been done by any other device on market. We are integrating different actuation modalities at the needle tip to help clinicians more effectively harvesting cell samples, also taking advantage of sensor to identify tumor region.

Our device can break the limitation of inadequate biopsy hampering timely and accurate pathology analysis. First visit accurate biopsy accelerates diagnostic and follow-up treatment, bringing down the treatment cost from about 5000 dollars to around 78 dollars for breast cancer patients.

 [FZ1]https://www.giendo.theclinics.com/article/S1052-5157(17)30069-7/fulltex

Our broad desired impact goals are as follows:

• Reduce mortality rate associated with breast cancer in rural and low resource regions
• Improve patient quality of life associated with breast cancer in rural and low resource regions
• Reduce economic burden (related to healthcare, travel, and lodging expenses) for patients and payers in rural and low resource regions

More specifically, we aim to:

• Improve the diagnostic workflow in breast cancer by eliminating the need for repeat biopsy procedures via increased cellular yield on the first pass
• Reduce the time between index patient clinical presentation to confirmative diagnosis
• Reduce the time between index patient clinical presentation to definitive treatment
• Reduce disease burden due to tumor upstaging during diagnostic lag time

Based on the cost benefit study conducted by our team targeting Kenyan government, we anticipate to save huge costs, by elimination of repeat procedures, timely diagnosis and accelerated cancer care.

The core technology of our device leverages the use of automated micro-movements incorporated to replace the manual technique of sample acquisition. The device has been developed by closely observing best clinicians performing the procedure with high adequacy during our ethnographic studies. We understand manual techniques to be highly dependent on user skill and as such, we have seen dramatic differences in cellular yield/adequacy between highly skilled clinicians in urban health centers and those of lower resourced/skilled staff (who often are not physician level training) in rural areas. Specifically, the manual excursions performed need to be done quickly, precisely, and with one hand (because there are limited clinical support staff to hold other instruments in rural areas). By incorporating automated micro-movements into the needle tip, we make the one-handed process much easier to perform and reduce the dependence on the user to precisely macerate tissue for cellular aspiration. The automatic needle movements will perform the tissue maceration delicately in a precise location, allowing for safer and more accurate sample acquisition.

full-time staff: Rida Amjed, Fujia Zheng, Sainkhuu Enkh-Otgon, Shirley Lin

part-time staff: Oriol Cuxart

1 year

Our leadership team is comprised as 66% women and 34% men. Our team, is global, meaning we have representation from multiple countries, with 3 co-founders coming from developing countries like India, China and Mongolia. Diversity hasn’t been a latter integration for us, but the project has been founded by the 5 team members from 5 different countries.

We have mentors and advisors from diverse countries such as Kenya, Uganda, Ethiopia, South Africa, India and United States who have been in heads of various organizations such as WHO- women's health, Jhpiego, Aga Khan, USAID. Johns Hopkins and other foundations,

We actively engage with the community of over 100 women in Kenya and Uganda, who are currently battling breast cancer and survivors to closely understand the pain points and empathize with their lives. We have collaborated with UWOCASO, BRECASO, Hospice care providers in Kenya for advocacy and awareness creation.