Breast core-needle diagnostics in LMICs via millifluidics and direct-to-digital imaging: development and validation in Ghana

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ABSTRACT Breast cancer is an increasing challenge globally as it became the most prevalent malignancy at the end of 2020. More than 70% of all cancer mortality now occurs in low- and middle-income countries (LMICs). Histology, critical to the diagnosis and disease management for many cancers notably including breast cancer, is currently performed using techniques that are more than 100 years old. Market forces, technological advances in optics, and innovation in care strategies are opening the door for disruptive innovation that could massively reduce costs and time and improve accessibility while provide equivalent or even superior results. We propose to contribute to the field's evolution by combining two already functioning and complementary technologies: 1) a tissue millifluidics approach (developed in PI Seibel's lab) for hands-off core needle biopsy handling; and 2) a rapid, low-cost, direct-to-digital slide-free imaging solution (developed in PI Levenson's lab). The goal is to implement a context-appropriate, automated instrument that can capture diagnostic-quality histopathology images from core-needle biopsies vital to high-quality breast-cancer diagnosis and staging, at time of procedure. Additional project goals include implementation of innovative rapid immunofluorescence methods for near-real-time therapy guidance; and development of AI tools for patient triage or even local diagnostic support, the latter under the direction of Dr. Mahmood (BWH), a leader in multiclass AI algorithms. Key to success of this project is local implementation and clinical evaluation in Kumasi, Ghana, under the direction of Dr. Addai, consultant breast surgeon and CEO of Peace and Love Hospitals (established in 2002). Her group will critically assess performance, usability, and compatibility with the service environment in both a central hospital and a remote satellite clinic; clinical validation studies will eventually encompass at least several hundred patients recruited under IRB-approved protocols. Additional guidance will be provided by Dr. Dan Milner, CMO of the American Society for Clinical Pathology (ASCP), who has extensive experience in global-health-focused initiatives, as well as by our collaborating pathologists who are familiar with issues relevant to LMIC settings. Feedback will inform the design of the second-generation automated instruments to be delivered near the end of this project.