An international team of imaging, engineering and cancer experts is developing a novel mobile breast cancer diagnostic kit to improve early diagnosis in low- and middle-income countries — such as Uganda, where systemic delays lead to an advanced stage diagnosis in 70% of breast cancer cases.
A newly awarded five-year, $4 million grant from the U.S. National Cancer Institute supports a partnership between Vanderbilt University Medical Center and the Uganda Cancer Institute (UCI) to optimize, validate, and deploy a portable diagnostic kit for breast cancer that merges innovative point-of-care technologies in ultrasound and cytology. The goal is for the kit to be used at community health centers that provide outpatient care in sparsely populated areas.
Delayed diagnosis is common in underserved communities, especially rural areas that lack hospitals, in the U.S. and around the world. In Uganda, for example, an average 11-month delay results in a high fatality rate.
The easily deployable kit will allow non-physician sonographers and cytopathology technologists to be trained to conduct the testing in rural primary care clinics in a single visit.
It combines an FDA-cleared automated artificial intelligence-enabled whole breast ultrasound scanner (ATUSA) and a smartphone-enabled AI-powered pathology device (EpiView-D4) that performs bright-field imaging of basic cytology preparations and incorporates a self-contained immunodiagnostic chip to quantify breast tumor biomarkers.
To validate the efficacy of the kit, radiologists at VUMC will interpret kit results in a group of 500 women who have breast symptoms. The patients will receive testing with both the standard-of-care method as well as the kit, which will then be interpreted by radiologists who have not seen results from the standard-of-care approach.
The diagnostic kit will also be tested and validated at UCI against diagnostic imaging and pathology standard of care using the same protocol used at VUMC to ensure performance is aligned with the standard of care in well-resourced settings.
After validation at VUMC and UCI, researchers will use the kit in a cluster randomized controlled trial of 2,000 women referred for diagnostic evaluation at four community health centers in Uganda and compare the clinical efficacy of the kit with symptomatic women referred for a standard-of-care ultrasound at Ugandan regional hospitals.
