Leica Biosystems, a prominent player in anatomic and digital pathology solutions, has announced a significant strategic investment in Indica Labs, a leader in AI-powered digital pathology software. This partnership aims to enhance the capabilities of digital pathology across various medical applications, including early biomarker discovery, clinical trials, and routine diagnostics. The announcement was made in a joint release from VISTA, California, and Albuquerque, New Mexico, on January 8, 2025.

The collaboration will lead to the development of a diagnostic digital pathology platform that integrates Leica Biosystems’ Aperio scanner portfolio with a tailored version of Indica Labs' HALO AP® image management software. This platform is designed specifically for clinical use and will be made available exclusively through Leica Biosystems.

The anticipated platform will offer a comprehensive suite of digital pathology functionalities, enabling both onsite and remote primary diagnosis while allowing users to incorporate AI applications of their preference via open application programming interfaces (APIs). Additionally, the companies plan to establish an AI applications marketplace, which will include both their proprietary apps and those from third-party developers.

In recognition of the need for Good Laboratory Practice (GLP) workflows, the partnership will also provide the HALO Link platform, which will feature collaborative, browser-based image management capabilities. This will allow distributed teams to securely manage, share, and analyse digital slides and related data.

Leica Biosystems has plans to integrate Indica Labs into its companion diagnostics (CDx) development programme, focusing on the design of next-generation AI-enabled CDx assays. This initiative is part of a broader strategy by Leica Biosystems, which operates CDx development projects at Centres for Enabling Precision Medicine in both the UK and the US, to assist pharmaceutical companies in improving patient access to innovative cancer therapies.

“This is a truly groundbreaking partnership designed to accelerate the advent of next-generation AI-enabled solutions in cancer diagnostics,” commented Gustavo Perez-Fernandez, President of Leica Biosystems. He further expressed pride in joining forces with Indica Labs to create an "exceptional computational pathology solution for customers and their patients."

Indica Labs’ CEO, Steven Hashagen, expressed enthusiasm for the collaboration, stating, “As two leading players in digital pathology, with complementary capabilities, this initiative will combine Leica Biosystems’ expertise and footprint in instrumentation with Indica’s expertise and footprint in enterprise software and AI.” Hashagen highlighted the potential of this partnership to mitigate barriers that often hinder rapid and reliable diagnoses for patients.

The HALO AP® product is CE-IVDR marked for in-vitro diagnostic use across Europe, the UK, and Switzerland, while its usage in the USA is restricted to research applications and is not FDA-cleared for clinical diagnostic practices. The platform is designed to comply with key regulatory frameworks, including FDA 21 CFR Part 11, HIPAA, and GDPR.

Piper Sandler & Co. acted as the exclusive strategic advisor for Indica Labs during this formation of the partnership. This collaboration illustrates the growing convergence of digital pathology and AI technologies, which many industry experts believe will significantly transform diagnostic procedures and enhance the accuracy of cancer care.

Source: Noah Wire Services