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Global Translational Medicine Rapid diagnostic imaging on biopsy needle

Globally, BC affects 2.8 million individuals annually, 1.2. Challenges in BC diagnosis in low-resource
causing approximately 690,000 deaths. Early diagnosis is settings
1,2
crucial for improved patient outcomes, as it significantly BC remains a major public health challenge in LMICs,
impacts an individual’s quality of life and ability to combat where resource limitations significantly impact diagnosis
the disease. Despite recent advances in preventive treatment and treatment. A major constraint is the shortage of essential
measures, BC remains highly prevalent, with one in eight equipment, inadequate organizational infrastructure,
women likely to develop the disease in their lifetime in the and an insufficient number of qualified personnel within
United States alone, making it a major focus for treatment pathology and lab medicine (PALM) services in such
3
improvement. In low-resource rural settings and low- and areas. PALM services are crucial for accurate disease
middle-income countries (LMICs), BC care presents detection and prognosis; without such services, patients
various challenges and has a much worse 5-year survival are often uninformed for extended periods without a
rate compared to higher-income countries (HIC). In the definitive diagnosis. Similar challenges are also observed
4,5
11
United States, for example, the 5-year survival rate is 83.9%; in remote and rural areas of HICs from a lack of funding
however, in LMICs, such as Gambia, it is as low as 12%. and continual closing of rural hospitals, restricting access
6
Overall, 58% of BC deaths occur in LMICs, underlining to PALM services. 11,12
the critical need for improved diagnostic and treatment
methods. In Ghana specifically, BC is the most common Although CNB plays a critical role in BC diagnosis
6
cause of cancer death for Ghanaian women. The main and treatment planning, the clinical procedure is often
7
reason is the late presentation of patients and diagnostic constrained by barriers, such as a shortage of trained
delays. With the introduction of new diagnostic devices, professionals to precisely acquire cores from the targeted
3-7
differences in patient care globally can be minimized. mass, as well as the equipment and supplies required to
process the specimens in adequately equipped histology
1.1. Current clinical practice in BC diagnosis facilities. More sophisticated techniques, including
13
In current clinical practice, two primary methods are ultrasound imaging and vacuum-assisted breast biopsy
commonly used for minimally invasive tissue sampling: fine- techniques, are not widely implemented due to cost
14
needle aspiration (FNA) and core-needle biopsy (CNB). considerations. Logistical constraints also hinder
8
While both techniques involve the extraction of cellular histopathological processing in LMICs. In low-resource
material using a needle, they differ in procedure, diagnostic settings, formalin-fixed paraffin-embedded (FFPE) tissue
efficacy, and clinical utility. FNA samples utilize smaller processing and pathologist diagnosis can take up to
needle gauges (22–25 gauge); however, they constitute 3 months to complete, compared to approximately 1 week
15
isolated cells and cell clumps without tissue architecture and in high-resource settings. In Ghana’s eastern region, the
thus can be suboptimal for diagnostics, requiring the expertise lack of local pathologists exacerbates delays, as samples
of a trained cytopathologist to ensure accurate analysis. In must be sent off-site for evaluation. 16
contrast, CNB utilizes a larger gauge needle (14–20 gauge) Early BC detection is further limited by healthcare
equipped with a spring-loaded cutting mechanism to excise barriers and social stigma, resulting in many patients
tissue samples from suspected tumors, providing superior only presenting with advanced disease in clinics. Studies
diagnostic accuracy, specificity, and sensitivity. 9 indicate that 20–30% of women with BC symptoms delay
The larger and more structurally intact tissue samples seeking medical care for at least 3 months. 3,17,18 In addition
obtained through CNB facilitate histopathological to limited healthcare infrastructure, the medical cost
evaluation, making it the standard of care for BC associated with BC diagnosis and treatment is a barrier for
diagnostics. Despite their diagnostic advantages, CNBs are many, and prevents timely diagnosis and treatment. 19
9
associated with higher procedural costs and require time-
intensive histopathological tissue processing workflows 1.3. The CoreView imaging on needle (ION) project
that contribute to delays in BC diagnosis and treatment In Ghana, treating cancer involves many indirect expenses
(Figure 1). In the United States, current trends involve that are not limited to those incurred during treatment.
pathologists seeking to optimize the biopsy process by A recent survey conducted among individuals seeking
reducing the number of samples required for an accurate cancer care in Ghana revealed that only 54.8% of the
diagnosis. Historically, patients underwent 5–10 CNBs per costs were solely medical, whereas direct non-medical
procedure; however, recent studies have indicated that 3–5 and indirect costs from seeking treatment made up 7.1%
cores are adequate for diagnostic or clinical management, and 38.1% of the overall expenses. Such costs included
20
and even as few as 2 cores may reliably allow for diagnosis the transportation fees, caregiver fees, and the loss of
of a malignancy. 10 productivity, deterring patients from seeking necessary

Volume 4 Issue 3 (2025) 107 doi: 10.36922/GTM025170039