Lung PD-L1 AI

Lung PD-L1 AI is an automated, AI-based decision-support tool that standardizes scoring of PD-L1 IHC in non-small cell lung cancer (NSCLC) on whole slide images (WSI) in accordance with clinical scoring guidelines. Lung PD-L1 AI is seamlessly integrated into HALO AP®. 

Regulatory Compliance 

Lung PD-L1 AI is For Research Use Only and not intended for clinical diagnostic use. Lung PD-L1 AI is accessed via the HALO AP® enterprise digital pathology platform.

HALO AP® is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AP is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use. In addition, HALO AP provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR.