Labcorp to Deploy FDA-Cleared Digital Pathology Platform Nationwide
Labcorp is expanding its collaboration with PathAI to deploy an FDA-cleared digital pathology platform across the country. The move signals a broader shift toward integrated, technology-enabled diagnostics combining imaging, lab services, and AI-powered analysis.
- The collaboration builds upon Labcorp's 2019 strategic investment in PathAI and has since expanded to include AI-supported clinical trials. Labcorp will also integrate the digital pathology workflow to enhance its precision medicine products. - PathAI's platform, AISight Dx, is a cloud-based image management system that received FDA 510(k) clearance for primary diagnosis. It is designed to be compatible with a wide range of whole slide imaging scanners, including those from Roche, Leica, and Hamamatsu. - The adoption of digital pathology is driven by the need to address a projected shortage of nearly 5,700 pathologists in the U.S. by 2030, coupled with rising diagnostic demand from an aging population. This technology enables remote slide review, which can improve access to specialists and streamline workflows. - The global digital pathology market was valued at over $1.32 billion in 2025 and is projected to exceed $3.82 billion by 2035, with a compound annual growth rate of over 11%. North America currently holds the largest market share. - AI algorithms in pathology can improve diagnostic accuracy by identifying subtle patterns that may be missed by the human eye, potentially reducing diagnostic errors by up to 85%. This can lead to earlier disease detection and more personalized treatment plans. - A significant trend in diagnostics is the shift of services from hospitals to outpatient settings, with about 40% of all radiology volume now occurring in outpatient clinics or imaging centers. Health systems are responding by expanding their freestanding imaging footprints through acquisitions, partnerships, or new construction. - Recent Medicare reimbursement changes have created a mixed financial landscape for imaging providers. While the 2025 Medicare Physician Fee Schedule saw an overall reduction in the conversion factor, payments for specific procedures like Coronary CT Angiography (CCTA) have increased, encouraging investment in related technology. Meanwhile, the 2026 Hospital Outpatient Prospective Payment System (HOPPS) finalized a 2.6% increase in payment rates for hospitals meeting quality reporting standards.
