Digital Pathology AI
N

Nucleai

Spatial biology company applying computer vision and machine learning to tissue imaging, integrating high plex spatial proteomics, histopathology, and clinical data to identify predictive spatial biomarkers. Positioned primarily for pharmaceutical R&D, supporting patient stratification and trial enrichment for antibody drug conjugates, bispecifics, and immunotherapies, with an emerging diagnostics application. Reported as the first spatial AI tool used by pathologists for clinical trial patient selection tied directly to a drug development program.

Last VerifiedJuly 21, 2026
Compare Nucleai with other vendors
Founded
2016
Headquarters
Tel Aviv, Israel
Website
nucleai.ai
Categories
pathology-ai, clinical-trials-ai, drug-discovery
Assessment

Capability Axes

AI Capability
AI Centrality
A
Vendor Published

Computer vision on tissue is the product and the company argues it does something humans cannot. Its stated case is that manual pathology image analysis is subjective, inconsistent, and highly variable because it rests on pathologist consensus, while its platform characterizes cell distribution and spatial relationships at a resolution no human reader can reach. The multimodal spatial operating system integrates high plex spatial proteomics, histopathology, and clinical data, and a separate deep learning model automates normalization of high plex imaging, a step previously done by hand.

Autonomy and Oversight Model
B
Vendor Published

Output feeds expert interpretation rather than replacing it. In the research setting a spatial proteomics agent generates reports from spatial datasets for translational teams to act on, and in the clinical setting the company describes its technology as used by pathologists for clinical trial patient selection. That last framing matters: a pathologist remains the decision maker even where the algorithm is embedded in trial enrollment criteria. Buyers should note that when an algorithm determines trial eligibility, the oversight question shifts from clinical safety toward selection validity.

Model and Technology Transparency
B
Vendor Published

The platform is described with real specificity about inputs and processing: it ingests H and E, immunohistochemistry, multiplex immunofluorescence, and spatial transcriptomics data, and produces quantitative spatial insights including cell architecture and neighborhood analysis. Work has been published and presented through peer reviewed and conference channels including AACR, ASCO, and SITC, with one study selected among the top abstracts from over 1,200 submissions. Model architecture and performance figures are not published.

Clinical and Operational Evidence
B
Vendor Published

Evidence is substantial on the research side and early on the clinical side. Named pharmaceutical partnerships apply the platform to clinical stage oncology assets, academic collaborations span multiple universities on colorectal and lung cancer biomarkers, and clinical trial data has been presented at major oncology meetings, including analysis of biopsies from a named melanoma trial identifying immune cell interactions linked to outcomes. A health system has explored the technology as a treatment decision tool in real world care. What does not yet exist publicly is prospective validation that spatial biomarkers derived by the platform improve treatment selection outcomes.

AI Safety and PHI Stewardship
Not rated

No published PHI or data governance framework was located. The platform processes patient biopsy images correlated with clinical records and outcomes, and the company describes linking spatial data with genomic data and historical electronic medical records, which is a broad data surface warranting direct diligence.

Regulatory and Compliance
HIPAA and BAA Posture
Not rated

No HIPAA or BAA commitment was located. The primary buyer is pharmaceutical R&D rather than a covered entity, though the clinical trial and health system applications would bring HIPAA into scope for US deployments.

Security Certifications and Trust Center
Not rated

No SOC 2, ISO 27001, or equivalent attestation was located in public materials.

FDA and Regulatory Status
Not rated

No FDA clearance is claimed and none was located. The company describes itself as a spatial biomarker and diagnostics company, and the diagnostics ambition is where regulation would eventually attach; today the disclosed use is research and clinical trial patient selection, which operates under trial protocols rather than device clearance. A buyer considering clinical diagnostic use should establish the regulatory basis explicitly, since research use and diagnostic use are different permissions.

AI Governance and Bias Disclosure
Not rated

No governance framework or bias evaluation was located. The pertinent question for spatial pathology is whether performance holds across staining protocols, scanner platforms, and tissue handling practices between sites, since those vary materially and the company's own automated normalization work implicitly acknowledges the problem without publishing an analysis of residual variation.

Integration and Deployment
EHR and Interoperability Depth
C
Vendor Published

Integration is with the pathology and research stack rather than the chart. The company has partnered with a digital pathology platform vendor to embed its predictive biomarker technology inside that vendor's software, and works alongside a spatial biology instrument maker's platform, which are meaningful workflow integrations in the laboratory. The company also references correlating spatial findings with genomic data and historical medical records. No EHR, HL7, or FHIR integration was located.

Deployment Model and Data Residency
C
Vendor Published

Described as a cloud based end to end analytics platform processing multiplex immunofluorescence, H and E, immunohistochemistry, and spatial transcriptomics data. No tenancy, hosting, or residency terms are published, which matters for a company headquartered in Israel serving pharmaceutical partners globally.

Commercial
Commercial Transparency
Not rated

No published pricing. The commercial model appears to combine pharmaceutical partnership agreements with platform access, and neither structure nor economics are disclosed.

Setting and Specialty Coverage
C
Vendor Published

Oncology focused, with disclosed work spanning melanoma, lung, colorectal, pancreatic, and immunotherapy response prediction, and explicit product positioning around antibody drug conjugates, bispecifics, and immunotherapies. The buyer is a pharmaceutical or biotech translational team rather than a provider organization, with academic collaborators as a secondary channel and clinical diagnostics as a stated direction rather than current scope.

Commercial

Pricing

Vendor-published figures are labeled as such. Figures labeled “Estimated” are derived from third-party sources and have not been confirmed by the vendor.

Entry Price Pricing Basis BAA Tier Implementation Source
Contact the vendor
Undisclosed. Buyers are pharmaceutical and biotech translational teams, academic collaborators, and emerging diagnostic customers. Not applicable to the primary pharmaceutical R&D relationship. Would need establishing for clinical diagnostic deployments. Not disclosed. The platform is also available embedded within a third party digital pathology software platform, which may offer a different procurement path for labs already on that system. Vendor Published

The commercial model appears to combine pharmaceutical partnership agreements with platform access, and neither structure nor economics are disclosed. Named partnerships with pharmaceutical companies applying the platform to clinical stage oncology assets indicate a collaboration shaped business rather than a per seat software sale, but no deal terms are public.

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Index Status
Last index update
July 21, 2026
The AI Health Index is an editorial reference, not a regulatory body. Vendor data is verified against published sources and public regulatory filings. Figures labeled “Estimated” have not been confirmed by the vendor. See the Methodology page for evaluation standards and limitations.
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