Leica Biosystems has announced a significant strategic investment in artificial intelligence (AI) specialist Indica Labs, marking a pivotal advancement in digital pathology. The collaboration, announced on 8 January 2025, aims to accelerate the development of AI-enabled companion diagnostics (CDx) and enhance the detection of complex biomarker expression profiles that exceed human visual capabilities.

The partnership’s cornerstone involves the creation of an innovative diagnostic digital pathology platform that integrates Leica Biosystems’ Aperio scanner technology with a customised version of Indica Labs’ HALO AP® image management software. This platform, to be distributed exclusively through Leica Bio-systems, will provide comprehensive enterprisegrade digital pathology workflow functionalities.

Technological implications

The platform’s architecture incorporates open interfaces (APIs) that facilitate the integration of third-party AI applications, demonstrating a commitment to interoperability. The companies plan to establish an AI applications marketplace, offering both proprietary and third-party solutions. For research organisations requiring Good Laboratory Practice (GLP) workflows, the partnership will provide access to the HALO Link platform, enabling secure, browserbased image management and analysis capabilities for distributed research teams.

Companion diagnostics advancement

A significant aspect of the collaboration involves the integration of Indica Labs into Leica Biosystems’ CDx development programme. Operating from Centres for Enabling Precision Medicine in the United Kingdom and United States, this initiative aims to enhance patient access to novel cancer therapeutics through partnerships with global pharmaceutical companies.

Regulatory considerations

It is noteworthy that while HALO AP has received CE-IVDR marking for in-vitro diagnostic use in Europe, the United Kingdom, and Switzerland, it remains designated For Research Use Only in the United States, pending FDA clearance for clinical diagnostic applications. The platform incorporates compliance measures for FDA 21 CFR Part 11, HIPAA, and GDPR regulations.

According to Gustavo Perez-Fernandez, President of Leica Biosystems: “This is a truly groundbreaking partnership designed to accelerate the advent of next-generation AI-enabled solutions in cancer diagnostics.”

Indica Labs CEO Steven Hashagen emphasised the complementary nature of the partnership, stating that “this collaboration between two companies dedicated to open pathology offers the potential to break down some of the barriers that prevent patients from receiving fast, reliable diagnoses and effective therapies”.