# Rapid highly multi-plexed immuno-profiling of solid tumors by SpectralEdge imaging

> **NIH NIH R44** · RARECYTE, INC. · 2020 · $1,145,798

## Abstract

PROJECT SUMMARY – ABSTRACT
 The dramatic impact of immune checkpoint inhibitors (ICIs) has focused interest in investigating
immune-tumor cell interactions to understand mechanisms of ICI sensitivity and resistance, to identify patients
responsive to specific drugs, and to develop new therapies. Multiplexed tissue imaging is a highly promising
approach to tumor immunoprofiling: it can assess many cell types and states within the context of preserved
tumor architecture and is compatible with pathology workflows. A critical unmet need exists for multiplex
technology with the following capabilities: (1) whole-slide imaging; (2) rapid single-pass data collection; (3) sub-
cellular imaging resolution; (4) sufficient immunoprofiling depth; (5) bright-field imaging capability; (6) optical
and mechanical stability for accurate image tile stitching; (7) availability of core and customizable antibody
panel kits for profiling; and (8) compatibility with established image data standards and formats.
 This RareCyte – Harvard Medical School Phase II proposal describes SpectralEdgeTM, a breakthrough
imaging technology that meets these requirements, performing high-resolution high-plex whole-slide imaging of
20 antigens labelled with fluorophore-conjugated antibodies in a single-pass scan of less than 1 hour. The
patented SpectralEdge method involves a novel instrument and software as well as highly validated
TissuePlexTM antibody panels. SpectralEdge imaging will accelerate discovery of predictive and prognostic
biomarkers, enable pharmacodynamics study of immuno-oncology drugs undergoing clinical trials and
ultimately provide clinically actionable diagnostic tests.
 Aim 1 will focus on engineering and production of a robust, production-ready slide scanner and
software for rapid high-resolution 20-plex SpectralEdge whole-slide imaging; it will be based on RareCyte’s
existing CyteFinder II imaging system. Production of a research-use-only instrument and reagents to
ISO13485 standards will enable subsequent deployment in a clinical setting. Compatibility with current and
emerging data format and software standards will enable integration with diverse research and clinical
workstreams.
 Aim 2 will test and validate modular antibody panels for immunophenotyping and tumor cell imaging
across a range of tumor types. This will yield validated TissuePlex panels having a core set of immunoprofiling
antibodies and antibody “modules” for individual tumor types.
 Aim 3 will test SpectralEdge imaging on well-characterized sample cohorts in: (i) translational
biomarker discovery, (ii) industry-sponsored and investigator-initiated immuno-oncology trials, (iii) mouse
models of cancer, and (iv) clinical specimens currently undergoing immunoprofiling with other diagnostic
methods. Clinical sample studies will be overseen by an advisory group of board-certified HMS pathologists.

## Key facts

- **NIH application ID:** 10152462
- **Project number:** 2R44CA224503-02
- **Recipient organization:** RARECYTE, INC.
- **Principal Investigator:** Eric Kaldjian
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,145,798
- **Award type:** 2
- **Project period:** 2018-04-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10152462

## Citation

> US National Institutes of Health, RePORTER application 10152462, Rapid highly multi-plexed immuno-profiling of solid tumors by SpectralEdge imaging (2R44CA224503-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10152462. Licensed CC0.

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