ClarusDx | Pathology at the speed of light

Pathology at the
speed of light.™

A new perspective on tissue.
Closer to the point of care.

We're advancing direct-to-digital tissue imaging to bring microscopic information closer to the decisions that matter.

Technology in development
A CLOSER LOOK
GigaFIBI tissue imaging instrument concept
01
Earlier information
Bringing tissue assessment closer to the clinical workflow.
02
Familiar microscopic detail
Digital images with the H&E appearance pathologists know.
03
More from each specimen
Developing workflows with subsequent tissue evaluation in mind.
THE TECHNOLOGY

Digital pathology.
Directly from tissue.

FIBI creates microscopic images directly from the specimen, bringing digital image acquisition earlier in the pathology workflow.

Fluorescence-imitating brightfield imaging reveals tissue architecture and cellular detail in full color. Our focus is on making this approach practical for fresh-tissue assessment, with images that pathologists can examine and interpret.

An imaging foundation for AI

Digital from acquisition, FIBI creates opportunities for computational analysis and AI development alongside pathologist expertise.

AI applications require their own development and validation.

THE IMAGING PRINCIPLE

How FIBI forms an image.

Controlled illumination and the tissue's own fluorescence reveal microscopic detail at the stained surface.

OPTICAL PRINCIPLE
Camera Optical separator Illumination Light from tissue Objective Surface stain Tissue Autofluorescent backlight Light generated within the tissue
A simplified optical schematic. The diagram illustrates the imaging principle, not the final instrument configuration.
View full-size diagram ↗
FROM TISSUE TO MICROSCOPIC DETAIL
Supplied tissue image with two green boxes marking regions of interest
Higher-magnification tissue detail, upper region Higher-magnification tissue detail, lower region
Images supplied by ClarusDx. Green boxes identify the regions shown at higher magnification.
Tissue architecture.
Cellular detail.
THE FIBI PLATFORM

Different specimens.
A common perspective.

Two configurations built around distinct clinical needs. One core approach to direct tissue imaging.

LARGE FORMAT IMAGING In development
GigaFIBI

Broad tissue-surface imaging, with an initial focus on breast lumpectomy margin assessment.

GigaFIBI development instrument from ClarusDx materials
Surgical specimen assessment Explore application ↗
CORE BIOPSY IMAGING In development
Needle FIBI

A compact configuration focused on earlier microscopic assessment of core biopsy material.

Small specimen.
Meaningful information.
Supporting the question:
Does this tissue meet the need?
Core biopsy assessment Explore application ↗
Instrument configurations and clinical applications are under development.
CLINICAL APPLICATIONS

Information with
an opportunity to act.

Development begins with a clinical question. We're working toward imaging that fits the people, specimens, and decisions around it.

{{ panel.eyebrow }}

{{ panel.q1 }}
{{ panel.q2 }}

{{ panel.p1 }}

{{ panel.p2 }}

DEVELOPMENT GOAL
{{ panel.goal }}
{{ panel.fine }}
PUBLISHED SCIENCE

A closer look
at the evidence.

Peer-reviewed research provides a foundation for continued development of FIBI.

Read the pilot study ↗
97.0%
Agreement with the reference diagnosis
across 400 FIBI reads
Pilot study of 100 formalin-fixed surgical pathology specimens, assessed by four pathologists. Agreement used the study's major-discordance criterion.
Borowsky et al., Arch Pathol Lab Med. 2024;148(3):345–352.
Normal breast tissue
{{ studyAlt }}
{{ studyCaption }}

These findings concern the study's imaging method and specimens. They do not establish the performance of final instrument configurations, fresh-tissue margin assessment, or AI diagnostic applications.

Study reference and image details +
Borowsky AD, Levenson RM, Gown AM, et al. A Pilot Validation Study Comparing Fluorescence-Imitating Brightfield Imaging, A Slide-Free Imaging Method, With Standard Formalin-Fixed, Paraffin-Embedded Hematoxylin-Eosin-Stained Tissue Section Histology for Primary Surgical Pathology Diagnosis. Archives of Pathology & Laboratory Medicine. 2024;148(3):345–352.
Images: Figure 4, reproduced from the supplied ClarusDx materials. Original magnifications: ×4 (A, D), ×40 (B, E), and ×20 (C, F). Minor diagnostic differences without treatment or outcome implications were included in the reported agreement measure.
doi:10.5858/arpa.2022-0432-OA ↗
OUR TEAM

Built around
clinical understanding.

Bringing pathology and imaging expertise together with experience in diagnostics development and commercialization.

LEADERSHIP
Mitch Levine
Chief Executive Officer
Ryan Andrews
GM & Chief Commercial Officer
Howard Sams, MBA
Chairman of the Board
SCIENTIFIC LEADERSHIP
Farzad Fereidouni, PhD
Chief Technology Officer
Emory University
Sandy Borowsky, MD
Chief Medical Officer
UCSF
LET'S ADVANCE TISSUE IMAGING

Bring your clinical
perspective.

We welcome conversations with pathologists, clinical investigators, and research collaborators.

ClarusDx
™
Pathology at the speed of light.™
Back to top ↑
Products and applications described are in development. Clinical applications require appropriate validation and regulatory authorization.
© 2026 ClarusDx, Inc.