Direct-to-digital pathology for faster breast biopsy results
Official title: Commercial Readiness for Direct-to-Digital Pathology
Funded at Applikate Technologies, INC. · NIH-11166523 · Data updated 2026-11-12
This project is preparing a new method that turns breast biopsy tissue into high-quality digital images within hours so adults facing possible breast cancer can get quicker results.
Quick facts
| Grant type | Sbir 2 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Applikate Technologies, INC. NIH-funded |
| Lab location | 1 site (Weston, United States) |
| Project start | January 1, 2024 |
| Project end | August 31, 2026 |
| Funding year | 2025 |
| Award (this year) | $1,628,449 |
| NIH project number | 5R44CA189522-07 |
| Project ID | NIH-11166523 on NIH RePORTER |
Who could benefit from this research
✓Could help
Adults aged 21 and older undergoing a breast biopsy or being evaluated for possible breast cancer would be the primary candidates for this work.
✕Less likely to help
Children under 21, people not undergoing biopsies, or patients with conditions outside the breast-cancer focus would likely not benefit directly from this project.
What this research studies
The team developed CHiMP, a way to clear and image intact biopsy tissue using multiphoton microscopy to produce H&E-like, true 3D digital images without wax embedding or slicing. Because CHiMP skips traditional slide preparation it can reduce common artifacts, preserve tissue for extra molecular tests, and deliver images much faster. This Phase IIb work builds the quality and risk-management systems and runs the clinical and laboratory validation needed for an FDA premarket approval submission. If validated, the system could enable remote image review and use with automated image tools to speed diagnosis and reduce lab staffing burdens.
Why it matters
Potential benefit: If successful, this could provide same-day, more accurate biopsy diagnoses, lower costs, and preserve tissue for additional testing.
How similar studies have gone: Digital pathology approaches have had clinical success, but CHiMP's specific clearing plus multiphoton direct-to-digital workflow is novel and is now undergoing clinical validation.
Where this research is happening
-
Applikate Technologies, INC.
Weston, United States Active
Researchers
- Principal investigator: Levene, Michael John — Applikate Technologies, INC.
- Study coordinator: Levene, Michael John
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.