What PathAI does

PathAI is a Boston-based AI-powered digital pathology company founded in 2016 that develops software, algorithms, and lab services used by biopharma sponsors, anatomic pathology laboratories, academic medical centers, and reference labs to improve diagnostic accuracy, accelerate drug development, and operationalize digital pathology workflows. The company's commercial surface spans two customer segments: BioPharma (drug sponsors and clinical trial operators) and Anatomic Pathology (clinical laboratories and health systems), with the stated mission of improving patient outcomes through AI-enabled pathology.

The core product is AISight, a cloud-native, open-platform Image Management System (IMS) that serves as the central hub for case management, slide review, and AI deployment across pathology workflows. AISight Dx is FDA 510(k)-cleared and CE-IVD-marked for primary diagnosis in the US and EEA/UK/Switzerland, integrated with Hamamatsu, Leica Aperio, Roche VENTANA, and Philips scanners and with major LIS systems via the AISight Link open API. PathAI's AI portfolio includes dozens of proprietary algorithms—PathExplore (600+ HIFs across 14 cancer indications), LiverExplore and AIM-MASH (1,000+ HIFs and the first AI-powered pathology Drug Development Tool qualified by both FDA and EMA for MASH trials), AIM-HI UC and IBDExplore for ulcerative colitis, AIM-PD-L1 and AIM-IHC Breast Panel for biomarker quantification, AIM-TumorCellularity and ArtifactDetect/TumorDetect for workflow, and the PLUTO/PLUTO-4 multimodal pathology foundation models. The Multi-Partner AI Portfolio on AISight embeds 40+ third-party algorithms (Deep Bio, Paige, Visiopharm, DoMore, Mindpeak, Stratipath, Primaa), and the company operates a CAP/CLIA-certified GCLP central pathology lab.

PathAI generates revenue through a diversified mix of streams: SaaS subscriptions and enterprise licensing of AISight and AISight Dx to biopharma and AP labs (100+ institutions), central pathology lab services for biopharma clinical trials, real-world data products licensed from quantitative HIF datasets, companion diagnostics development and commercialization, and a new Precision Pathology Network (launched July 2025) that monetizes data and algorithm access across a federated lab network. The company has raised approximately $355M+ in venture funding across multiple rounds led by General Catalyst, General Atlantic, D1 Capital Partners, and Kaiser Permanente, with strategic investors including Labcorp, Bristol-Myers Squibb, and Merck. On May 7, 2026, Roche entered into a definitive merger agreement to acquire PathAI for up to $1.05 billion, with closing expected in the second half of 2026.

Name

PathAI

Legal name

PathAI, Inc.

Website

https://pathai.com

Company type

Private

Founded year

2016

Operating status

Acquired

Headcount range

101–250 employees

Short description

PathAI develops AI-powered digital pathology software and central lab services for biopharma drug development and clinical diagnostics. Its AISight platform integrates proprietary algorithms—including PLUTO foundation models and disease-specific biomarker panels—for primary diagnosis, trial endpoints, and laboratory workflow across global pathology laboratories.

Ownership category

akta.pro rank

Product category

AI-Powered Digital Pathology

NAICS

Diagnostic Imaging Centers (621512), Software Publishers (5132), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Surgical & Medical Instruments & Apparatus (3841), Services-Prepackaged Software (7372)

akta.pro primary industry

Vendor Neutral Archive (VNA) & Enterprise Imaging Repositories (HLACALAC)

akta.pro secondary industries

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM), Site & Investigator Platforms (Site Payments, Feasibility, Activation) (HLACAOAJ), eCOA/ePRO/eDiary & Patient-Facing Data Collection (HLACAOAB)

Keywords

• Digital pathology
• AI pathology algorithms
• Biomarker quantification
• Clinical trial analytics
• Companion diagnostics

Headquarters

HQ city

Boston

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Central Pathology Lab Services: PathAI operates an in-house CAP/CLIA-certified GCLP histopathology lab providing end-to-end clinical trial services for biopharma partners including receipt/processing/staining, scanning, manual central pathology reads, AI-powered reads, and reporting. Currently 12 active or upcoming trials across 8+ biopharma partners.
2. AISight Platform SaaS Subscription: SaaS-based AISight Clinical Trials platform with cloud-based secure access, GCP/GCLP compliant, ISO 27001 certified, 21 CFR Part 11 compliant. Sold to biopharma and anatomic pathology labs as recurring software subscription.
3. AISight Dx Enterprise IMS Licensing: Enterprise digital pathology platform (AISight/AISight Dx) deployed to anatomic pathology institutions across academic medical centers, reference labs, health systems, and biopharma as image management system. Revenue from enterprise licensing to 100+ institutions.
4. Real-World Data Products: License quantitative histopathology data products (PathExplore HIFs) linked to structured clinical and molecular data from partner reference labs and TCGA. Available free to academic researchers; licensed for non-academic partners.
5. Companion Diagnostics Development & Commercialization: Bespoke diagnostic assays and AI-powered companion diagnostics including SaMD design, validation, regulatory and market access strategy, commercialization via partnerships across healthcare ecosystem.
6. Clinical Trial Services & Translational Research: AI-powered endpoint measurement, patient enrollment/stratification, prospective algorithm development under GCP/GCLP/CAP/CLIA, integration with 80% of global central lab providers. Includes AI-powered histology for trial enrollment and endpoint assessment.

Go-to-market motion1 record

Core offering

PathAI develops and sells AI-powered digital pathology software and services. The company's flagship AISight platform (and its FDA-cleared/CE-IVD-marked AISight Dx variant) serves as a cloud-native enterprise image management system used by 100+ anatomic pathology institutions for primary diagnosis, workflow optimization, and AI-driven biomarker quantification. PathAI also operates a CAP/CLIA-certified GCLP central pathology lab delivering end-to-end clinical trial services, companion diagnostic development, and real-world histopathology data products to 8+ biopharma partners.

Differentiator

Problem solved

Functional benefit

Brands

• AISight: Cloud-native, open-platform enterprise image management system for digital pathology workflows; includes AISight Dx (FDA 510(k) cleared and CE-IVD marked) for primary diagnosis.
• PathExplore
• IHCExplore
• LiverExplore
• IBDExplore
• AIM-MASH
• AIM-IHC Breast Panel
• PathAssist Derm
• AIM-HI UC
• PLUTO
• Precision Pathology Network

Products and services

• AISight Image Management System (IMS) Cloud-native, open-platform enterprise image management system for anatomic pathology, serving as the central hub for case management, image management, and embedded AI applications. Sold to academic medical centers, reference labs, health systems, and biopharma. Research Use Only in the US.
• AISight Dx Digital Pathology Platform Cloud-native digital pathology platform FDA 510(k) cleared (with PCCP) for primary diagnosis in the US (Hamamatsu NanoZoomer S360MD, Leica Aperio GT 450 DX, Roche VENTANA DP200/DP600) and CE-IVD marked in the EEA, UK, and Switzerland. Streamlines diagnostic workflows with intelligent case management, slide review, and collaboration.
• AISight Clinical Trials Platform Secure, cloud-based SaaS platform that enables AI-powered algorithms and digital pathology reads in prospective and retrospective clinical trials, supporting eligibility, stratification, response monitoring, quality control, and exploratory analysis. GCP/GCLP-compliant with 21 CFR Part 11 and ISO 27001 certification.
• Precision Pathology Network (PPN) First global network of digital anatomic pathology laboratories powered by AISight, providing early AI algorithm access, real-world data monetization, biopharma-sponsored evidence-generation studies, and clinical development partnerships to member labs.
• Central Pathology Laboratory Operations In-house CAP/CLIA-certified GCLP histopathology lab providing end-to-end clinical trial services for biopharma partners, including receipt/processing/staining, scanning, manual central pathology reads, AI-powered reads, and reporting. Currently 12 active or upcoming trials across 8+ biopharma partners.
• Companion Diagnostics Development & Commercialization Bespoke diagnostic assay development, AI-powered companion diagnostics, SaMD design, validation, regulatory and market access strategy, and commercialization via healthcare ecosystem partnerships for biopharma.
• PathExplore AI-powered panel of histopathology features that spatially characterize the tumor microenvironment (TME) from H&E whole slide images with single-cell resolution, delivering >600 unique Human Interpretable Features (HIFs) per sample across 14 cancer indications. For Research Use Only.
• LiverExplore (AIM-MASH+) AI-powered panel of >1,000 quantitative HIFs that spatially characterize liver tissue biopsy microarchitecture from H&E whole slide images for MASH and other liver diseases, including automated detection of >20 tissue regions, >10 cell types, and fibrosis subtyping. For Research Use Only.
• IBDExplore AI-powered panel of histopathology features that spatially characterize the inflammatory microenvironment from H&E whole slide images, with 12 tissue regions, 10 cell types, and >1000 HIFs. Built and assessed on Ulcerative Colitis biopsies. For Research Use Only.
• IHCExplore AI-powered IHC assay quantification at tissue, cellular, and subcellular resolution; extracts key histopathological features from IHC slide images and transforms IHC whole-slide images into quantitative insights for biomarker development. For Research Use Only.
• AIM-MASH AI Assist AI-based measurement tool providing MASLD Activity Score (MAS) component grades and fibrosis stages to aid a single central pathologist for enrollment/inclusion of patients into clinical phase 2 and 3 MASH trials and evaluation of study outcomes. First AI-powered pathology Drug Development Tool with FDA and EMA qualification.
• AIM-IHC Breast Panel AI-based measurement panel of key breast cancer biomarkers — HER2, ER, PR, and Ki-67 — fully integrated into the AISight Image Management System. Multi-clone and multi-scanner compatible with explainable AI heatmaps using additive multiple instance learning. For Research Use Only.
• PathAssist Derm AI-powered dermatopathology workflow solution with FDA Breakthrough Device Designation that analyzes digital pathology whole slide images of skin lesions and assists pathologists in their review. For Research Use Only.
• PLUTO / PLUTO-4 Pathology Foundation Model State-of-the-art pathology foundation model (with PLUTO-4 as latest frontier version) that enhances AI-powered pathology tools via transfer learning and fine-tuning for downstream tasks, combining histopathology images with language for multimodal disease classification.
• AIM-HI Ulcerative Colitis (AIM-HI UC) AI-powered Geboes subgrade scoring tool assisting pathologists in accurately and reproducibly measuring histological stage for ulcerative colitis clinical trial endpoint assessment, trained on >9,000 biopsies from six clinical trials; bridges Geboes, Robarts Histopathology Index, and Nancy Histological Index scoring systems. For Research Use Only.

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration17 records

AI capability13 records

Feature11 records

Recent moves8 records

Expansion highlights6 records

Others

• Labcorp: Labcorp is a strategic investor in PathAI since 2019 and recently expanded collaboration to deploy AISight Dx nationwide (Feb 2026). Labcorp is both a major customer of PathAI's digital pathology platform and an anatomic pathology services competitor through its diagnostics business.

Direct peers

• Proscia: Proscia offers a cloud-native digital pathology platform (Concentriq) with embedded AI applications and a biopharma services offering, directly competing with PathAI's AISight IMS and PathExplore products. Proscia serves similar anatomic pathology labs and biopharma customers in translational research and clinical trials.
• Owkin: Owkin is an AI pathology and biopharma services company that builds proprietary AI models on histopathology data for drug development and diagnostic applications. Owkin's biopharma-focused AI pathology approach directly overlaps PathAI's clinical trial services and companion diagnostics offerings.
• Ibex Medical Analytics: Ibex is a direct competitor in AI-powered cancer diagnostics, with deployments at multiple tier-1 health systems globally for prostate, breast, and gastric cancer detection. Ibex's Galen platform competes head-to-head with PathAI's AISight Dx and AIM-* diagnostic algorithms in primary diagnosis workflows.
• Visiopharm: Visiopharm is a peer AI pathology company offering APPs for breast cancer biomarkers (ER, PR, Ki-67, HER2) and PD-L1, with IVDR clearance in EU/UK. Visiopharm is integrated as a partner algorithm within PathAI's AISight ecosystem but also competes as a standalone pathology AI platform.
• Paige AI: Paige AI is a direct competitor in AI-powered digital pathology, offering FDA-authorized AI products for prostate, breast, and pan-cancer diagnostic pathology integrated into enterprise pathology workflows. Paige.AI's diagnostic suite directly overlaps PathAI's AIM-IHC Breast Panel and AISight Dx offerings, serving the same biopharma and anatomic pathology lab customers.

Broad incumbents

• Tempus AI: Tempus AI is a broader precision medicine and AI-driven diagnostics company with multimodal data capabilities including pathology, genomics, and clinical data. Tempus competes in biopharma services and RWD monetization, with adjacent pathology AI capabilities that overlap PathAI's clinical trial services and data products.
• Roche Diagnostics: Roche Diagnostics is the parent/acquirer of PathAI and a broad incumbent in the diagnostics industry with the VENTANA scanner installed base and navify digital pathology platform. PathAI's AISight IMS will integrate into Roche Diagnostics' broader portfolio upon closing of the acquisition announced May 2026.

Emerging players

• Deep Bio: Deep Bio is a Korean AI pathology company offering CE-IVD-marked DeepDx Prostate diagnostic aid, integrated as a partner algorithm in PathAI's AISight Multi-Partner AI Portfolio. Deep Bio recently trimmed headcount and is relying on distribution partnerships including PathAI and Roche Diagnostics.
• Mindpeak: Mindpeak is an emerging AI pathology company with CE-IVD-marked AI for breast cancer biomarker analysis (HER2, ER/PR, Ki-67) and lung PD-L1. Mindpeak is integrated into PathAI's AISight Multi-Partner AI Portfolio but also operates as an independent pathology AI vendor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/Path_AI
• YouTubeyoutube.com/@Path_AI
• LinkedInlinkedin.com/company/pathai

Compliance9 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles15 records

Subsidiaries1 record

Funding overview

Funding rounds6 records

Investors20 records

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M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PathAI