# Leveraging Label-Free Digital Imaging to Enable Rapid On-Site Evaluation (ROSE) During Thyroid Biopsy Procedures

> **NIH NIH R43** · PATHWARE INC. · 2023 · $399,994

## Abstract

Project Summary/Abstract
Pathware is developing Bioptic™, an imaging platform to analyze biopsy samples at the point-of-care. The
system will rapidly digitize unstained biopsy samples and utilize computer-aided detection/diagnostics to enable
quick and efficient evaluations by pathologists. Typical barriers to point-of-care diagnostics are overcome by
combining novel computational microscopy with AI (Artificial Intelligence) algorithms to direct on-site or remote
pathologists to regions of clinical interest. This proposed research's broad, long-term objective is to enable real-
time diagnostics of pathology samples at the point-of-care.
Thyroid nodules have a high incidence rate, and assessment via fine-needle aspiration (FNA) biopsy is often an
integral step in the diagnostic pipeline. The biopsy samples are frequently inadequate for diagnosis resulting in
repeat biopsies or unnecessary surgical resections. Rapid On-Site Evaluation (ROSE) for sample adequacy is
ideal for patient care, because it mitigates the risk of inadequate samples by verifying diagnostic quality at the
point-of-care. Despite the high incidence of inadequate biopsies, ROSE is performed in less than 25% of thyroid
biopsy procedures due to financial and operational barriers, including pathologist availability. The current
alternatives to ROSE (telepathology, robotic microscopy, and live-streaming microscopy) are plagued by barriers
to adoption due to the requirement of staining samples, technical challenges, and regulatory limitations. AI-
assisted ROSE has the potential to overcome these barriers and provide a superior standard-of-care.
The immediate goals of the proposed project are to 1) demonstrate non-destructive imaging of unstained thyroid
cytology smears with a novel microscopy modality and 2) train AI algorithms on the acquired images for future
development of computer-aided detection algorithms for ROSE adequacy assessments.

## Key facts

- **NIH application ID:** 10756316
- **Project number:** 1R43CA285170-01
- **Recipient organization:** PATHWARE INC.
- **Principal Investigator:** Troy Holsing
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $399,994
- **Award type:** 1
- **Project period:** 2023-07-03 → 2024-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10756316

## Citation

> US National Institutes of Health, RePORTER application 10756316, Leveraging Label-Free Digital Imaging to Enable Rapid On-Site Evaluation (ROSE) During Thyroid Biopsy Procedures (1R43CA285170-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10756316. Licensed CC0.

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