# Rapid Needle Biopsy Assessment at Point of Care to advance personalized cancer therapy

> **NIH NIH R21** · UNIVERSITY OF WASHINGTON · 2021 · $284,784

## Abstract

Project Summary
Currently there are no standard guidelines followed for core needle biopsy (CNB) acquisition and
preparation. Millions of CNBs are procured annually as the preferred minimally invasive procedure for
diagnosing breast cancer and assessing therapeutic strategies based on biomarkers from these small
biospecimens. However, the downstream steps in pathology were originally not designed for CNBs – a
series of manual procedures that are not standardized. These are: adequacy testing, fixation &
dehydration, paraffin embedding, thin-sectioning, staining for image-based morphological analysis,
immuno-histochemical (IHC) analysis, and subsequent microdissection to enrich for RNA extraction.
Our project is designed to rapidly evaluate the CNB for adequacy, the presence of cancer cells to make a
diagnosis, using CoreView millifluidic device from the University of Washington, Seattle. Automated
computer-controlled fluidic pumps help to remove the CNB from the needle, transport, clean and stain
the tissue surface in a repeatable system designed for CNBs. In partnership with the University of
California at Davis, the new method of microscopy with ultraviolet surface excitation will be used which
rapidly produces images appear to match the standard H&E images used for adequacy testing. In
addition, MUSE will be expanded to include multiplexed molecular of the same CNB. High clinical
impact for personalized medicine is provided by this multiplexed fluorescence immunostaining of the
biopsy to determine ER/PR and HER2 expression levels that are co-registered with the virtual H&E. The
entire process of multiplexed MUSE imaging at the point of care allows the specimen to remain unfixed
during this process, which triages one of the CNBs into genomic and other ‘omics analyses in the future
that require high yield and quality of biomarkers. The other 1 or 2 CNBs can continue into formalin
fixed paraffin embedded conventional histopathology work flow for the future validation of this rapid
assessment system. In this feasibility study, the first molecular and morphological CNB instrumentation
will be designed and fabricated based on CoreView-MUSE patented technologies. Testing will compare
the CNB surface images compared to conventional thin section H&E and IHC as well as the quality and
quantity of RNA from these two approaches. Pilot testing of full automation will determine the
ultimate speed of processing from needle to multimodal adequacy determination that should range
from 5 to 15 minutes at the point of care. Once developed and validated for breast cancer, the
CoreView-MUSE system will be expanded to lung, pancreas, and other cancers that rely on CNB
accurately sampling cancer from the lesion and providing phenotype classifications for precision
therapies.

## Key facts

- **NIH application ID:** 10129922
- **Project number:** 5R21CA246359-02
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Eric J Seibel
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $284,784
- **Award type:** 5
- **Project period:** 2020-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10129922

## Citation

> US National Institutes of Health, RePORTER application 10129922, Rapid Needle Biopsy Assessment at Point of Care to advance personalized cancer therapy (5R21CA246359-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10129922. Licensed CC0.

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