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
Accessing Lung PD-L1 AI in our CE-marked case management and viewing platform, HALO AP®, provides end-to-end integration to scanners and LIS | LIMS while providing built in compliance and certifications: CE-IVD, FDA 21 CFR Part 11, ISO 13485:2016, HIPAA, and GDPR.
Lung PD-L1 AI is for Research Use Only and not intended for clinical diagnostic use.
HALO AP® is CE-marked for in-vitro diagnostic use in Europe and the UK. HALO AP is For Research Use Only in the US and is not FDA cleared for clinical diagnostic use.