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Global Translational Medicine                                      Rapid diagnostic imaging on biopsy needle



            evaluation in a standard workflow. Compression allowed
            for sharper image quality across the length of the CNB and
            expanded the area being imaged by up to two times the
            original area.
              A significant strength of the system lies in its minimal
            requirements for electrical power. The CoreView
            prototype operates with only three components requiring
            electrical power (LED: 1.5W, Ximea camera: 3.0W, and   Figure  11. Reusable BARD  coring needle handpiece  and  low-cost
            a computer, which can be a battery-powered laptop),   disposable needle are displayed to the photographer during a training
            showing promising proof-of-concept work for low-cost   course in Rwanda on breast biopsy procedure for palpable breast masses.
                                                               The photograph is provided by Dr. Jane Brock, formerly at Brigham and
            and accessible solutions for rural and low-resource clinical   Women’s Hospital, Harvard University.
            settings. With a total cost of goods of less than USD 8,000
            (excluding labor), including a camera costing USD 4,000,   not  yet  been  refined  for  clinical-grade  imaging.  Further
            the system offers an affordable option compared to existing   optimization is  necessary  to  enhance contrast, reduce
            digital pathology solutions. While the CoreView ION has   imaging artifacts, and improve overall diagnostic quality.
            not been fully automated, this was found unnecessary for   Furthermore, the study has not yet demonstrated high-
            achieving rapid imaging and analysis, specifically for the   quality imaging of malignant BC human tissues. The
            stain protocol. The simplicity and speed of the system   initial  results  provide  a foundation  for future  work, but
            suggest that automation could easily be implemented in   additional validation using a diverse range of cancerous
            future iterations, but even in its current form, the workflow   tissues is required to assess the system’s true diagnostic
            remains efficient and practical. If further automation and   potential. These limitations highlight areas for future
            higher-powered  LEDs  were  implemented,  the  5-min   improvement, including optimization of the staining and
            process  could  be  even  faster  while  minimizing  errors.   imaging workflow, cost reduction strategies, and expanded
            With increased speed provided by system automation, a   validation studies to ensure clinical applicability with and
            20× objective could be implemented at an incrementally   without  artificial  intelligence  (AI)  enhanced  diagnosis
            higher cost.                                       from the resulting CoreView ION images.
            3.5. System limitations and challenges             3.6. Future improvements and optimization
            While the CoreView prototype offers a promising proof-  As  the  CoreView  ION  is  an  initial  proof-of-concept
            of-concept for rapid and low-cost imaging of CNBs in BC   prototype, there are potential directions for further
            diagnostics, several limitations must be considered before   refinement of the imaging strategy and design. At present,
            clinical implementation. One major limitation is the   the prototype depends on a computer system for MUSE
            expectation that a single core is sufficient for a diagnosis. If   imaging, necessitating access to electrical power and
            a second core is needed, then the needle would necessitate   a computer connection. However, recent studies have
            a thorough cleaning and rinsing protocol, introducing   demonstrated the feasibility of utilizing MUSE imaging
            potential workflow inefficiencies and requiring further   through smartphones.  The Pocket MUSE system, which
                                                                                 24
            validation for sterility. An example of global use of a reusable   employs an optical module attached to the rear lens of a
            CNB device (Figure 11), which could be incorporated into   smartphone, facilitates high-quality fluorescence imaging
            a CoreView ION imaging workflow, with multiple clean   at a significantly reduced cost. Incorporating Pocket MUSE
            needles being used with one reusable biopsy gun.
                                                               technology  and  concepts  into  the  CoreView  ION  could
              Another issue with the system is the dependence on   eliminate the requirement for a computer connection,
            quartz coverslips, which are significantly more expensive   enhancing its usability in rural settings. Furthermore, the
            than standard glass slides. This cost factor may present   existing low-powered UV LEDs in the current fixture could
            a barrier to widespread adoption, particularly in low-  potentially be replaced with a battery-powered module,
            resource, rural settings where affordability is a primary   allowing the system to operate solely on battery power.
            concern. Between each sample, the quartz glass required   The current prototype relies on a clean transparent
            cleaning or replacing if broken, leading to workflow   coverslip,  which  introduces  workflow  inefficiencies  and
            inefficiency between samples.
                                                               cleaning challenges. Recent advancements in imaging
              In addition, the imaging workflow and staining process   technologies, such as fluorescence-imitating brightfield
            remain  unoptimized. The  current staining and  imaging   imaging (FIBI), have demonstrated the capability to
            parameters were developed as proof-of-concept and have   capture tissue  images without coverslip compression. 26,27


            Volume 4 Issue 3 (2025)                        115                          doi: 10.36922/GTM025170039
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