# Commercial Readiness for Direct-to-Digital Pathology

> **NIH NIH R44** · APPLIKATE TECHNOLOGIES, INC. · 2023 · $224,925

## Abstract

Project Summary
Applikate Technologies has developed Clearing Histology with Multiphoton Microscopy (CHiMP), a novel
tissue processing and imaging platform that provides direct-to-digital images from intact pathology tissue
specimens, such as biopsies, without the need for wax embedding, slicing, or scanning of slides. The
application of this technology to cancer diagnosis will reduce errors, lower costs, ameliorate technician staffing
issues, and provide same-day diagnosis for patients waiting to hear if they have cancer.
The aim of this Phase IIb SBIR proposal is to support the development of risk management and quality
systems management required for the manufacture of clinical devices, as well as the clinical and non-clinical
validation testing required for an application for premarket approval by the FDA.
CHiMP has many advantages for general histology, including: H&E-like images familiar to pathologists but with
superior image quality, sub-micron effective thickness, and without artifacts common to slide preparation; non-
destructive imaging that preserves intact tissue for ancillary molecular analysis and immunohistochemistry;
rapid turnaround, with images ready within a few hours of receiving tissue; greatly reduced labor costs; true 3D
prospective; and digitized images for remote consultation and machine vision. The market for pathology
equipment and consumables is $2B, and for digital pathology scanners it is $1B. CHiMP is poised to not only
enter these markets as a unique and strong competitor, but to actually expand upon them by lowering the
barrier to entry for digital pathology through seamless integration into the laboratory workflow and raising the
value of equipment and supplies while still lowering overall costs to hospitals through significant labor savings.
The specific aims of this proposal are to: 1) Perform risk analysis; 2)Develop and implement a Quality
Management System; 3) Collect data for an FDA premarket submission and facility registration.
Successful completion of these aims will enable CHiMP to enter the clinical diagnostic market, where it can
have maximum impact on patient care and health economics.

## Key facts

- **NIH application ID:** 10678409
- **Project number:** 2R44CA189522-04A1
- **Recipient organization:** APPLIKATE TECHNOLOGIES, INC.
- **Principal Investigator:** Michael John Levene
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $224,925
- **Award type:** 2
- **Project period:** 2023-09-19 → 2023-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10678409

## Citation

> US National Institutes of Health, RePORTER application 10678409, Commercial Readiness for Direct-to-Digital Pathology (2R44CA189522-04A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10678409. Licensed CC0.

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