Company Profile
PathAI, Inc. is a US-based developer of AI-powered digital pathology platforms and diagnostic algorithms, headquartered in Boston, Massachusetts, USA. Founded in 2016 by Dr. Andy Beck (co-founder ＆ CEO) and Aditya Khosla (co-founder ＆ CTO), the company operates as an independent private entity pending acquisition by Roche Holding AG, serving global pathology laboratories, health systems, and biopharma markets with cloud-native image management and AI analysis tools.
Core Products ＆ Technologies
Digital Pathology Platform
• AISight® Dx: FDA-cleared cloud-native digital pathology image management system (IMS) for primary diagnosis, featuring slide management, viewing, collaboration, and AI integration; includes authorized Predetermined Change Control Plan (PCCP) for streamlined updates
• ArtifactDetect: AI-powered workflow tool for quality control and artifact detection in digital slides
• TumorDetect: AI algorithm for research-use-only tumor detection and annotation
AI Diagnostic Algorithms
• PathAssist™ Derm: AI-powered dermatopathology workflow solution for skin lesion assessment and case prioritization; FDA Breakthrough Device Designation (March 2026)
• AIM-HER2 Breast: AI algorithm for HER2 scoring in breast cancer pathology
• AIM-MASH AI Assist: AI-powered pathology drug development tool for MASH/MASLD clinical trial evaluation; qualified by both FDA and EMA as the first AI-driven pathology DDT
Biopharma Services
• Precision Pathology Network: Multi-site digital pathology laboratory network for clinical trials, translational research, and real-world data generation
• Companion Diagnostic Development: AI-enabled CDx algorithm development in partnership with Roche Tissue Diagnostics
Market Position ＆ Certifications
PathAI holds an emerging leadership position in the AI-powered digital pathology market, competing with Paige and Aiforia in AI pathology software. Key strengths include:
• 10 years of US AI pathology innovation heritage since founding
• Regulatory firsts: First FDA-cleared digital pathology IMS with authorized PCCP; first AI-powered pathology drug development tool qualified by FDA and EMA
• Clinical deployment: AISight Dx deployed across Labcorp's national anatomic pathology network and MedStar Health's multi-site laboratory system
• Strategic backing: $490M total funding raised including Series C with Labcorp, Bristol Myers Squibb, and Merck GHI; $95M debt financing (January 2025)
• Global partnerships: Multi-year collaborations with Roche (since 2021), Labcorp (since 2019), Quest Diagnostics, Moffitt Cancer Center, and Northwestern Medicine
Corporate Timeline
2016 — Founded in Boston, Massachusetts, USA
2019 — Closed Series B financing; established strategic partnership with Labcorp
2021 — Closed $165M Series C led by Labcorp, with Bristol Myers Squibb and Merck GHI participation
2022 — Received initial FDA 510(k) clearance for AISight Dx
2024 — Announced strategic partnership with Quest Diagnostics; expanded Roche partnership to include AI-enabled companion diagnostic algorithm development
2025 — Secured $95M debt financing (January); AISight Dx received FDA 510(k) clearance with PCCP (June); AIM-MASH AI Assist qualified by FDA and EMA as first AI pathology DDT (December)
2026 — Granted FDA Breakthrough Device Designation for PathAssist Derm (March); partnered with MedStar Health for multi-site deployment (April); Roche announced $1.05B acquisition agreement (May 7)
Target Markets ＆ Applications
• Clinical Pathology: AISight Dx for primary diagnosis, workflow optimization, and remote collaboration in hospital and reference laboratories
• Dermatopathology: PathAssist Derm for AI-assisted skin lesion assessment and melanocytic case prioritization
• Oncology Diagnostics: AI algorithms for HER2, MASH, and biomarker quantification supporting precision oncology
• Drug Development: PathAI biopharma services for clinical trial pathology, translational research, and companion diagnostic co-development
Contact Information
Global Headquarters
Address: 1325 Boylston Street, Suite 10000, Boston, MA 02215, USA
Telephone: +1 (617) 500-8457
Email: info@pathai.com
Parent Company (Pending Acquisition)
Roche Holding AG
Address: Basel, Switzerland
Stock: SIX: RO, ROP / OTCQX: RHHBY
Website: roche.com
Investor Relations: roche.com/investors
