Leica Biosystems and Indica Labs Announce Significant Strategic Investment and Creation of Digital Pathology Platform

Combining leading hardware and software is expected to provide a compelling solution for digital pathology users across the full translational medicine paradigm, from early biomarker discovery to clinical trials, and through to routine diagnostics.

VISTA, Calif. and ALBUQUERQUE, N.M., Jan. 8, 2025 /PRNewswire/ -- Leica Biosystems, a global leader in anatomic and digital pathology solutions, and Indica Labs, a global leader in artificial intelligence (AI)-powered digital pathology software, today announced that Leica Biosystems has agreed to make a significant strategic investment in Indica Labs. This partnership has the potential to accelerate AI-enabled companion diagnostics (CDx) and support discoveries and treatments based on discrete or complex biomarker expression profiles which are not discernable by the human eye.

As part of the agreement, Leica Biosystems and Indica Labs plan to launch a diagnostic digital pathology platform, pairing Leica Biosystems' Aperio scanner portfolio with a customized version of Indica Labs' HALO AP® image management software, for use by clinical customers. The platform will be available exclusively from Leica Biosystems.

The platform is expected to provide customers with a full suite of enterprise-grade digital pathology workflow functionalities, supporting onsite and remote primary diagnosis, and enabling customers to integrate AI applications of their own choosing through comprehensive open interfaces (APIs). The companies also expect to open an AI applications marketplace, offering both their own and third-party applications. 

For customers with a need for Good Laboratory Practice (GLP) workflows, the companies expect to offer the HALO Link platform with collaborative browser-based image management features, enabling distributed teams to safely and securely manage, share, and analyze digital slides and data.

Additionally, Leica Biosystems expects to integrate Indica Labs into the company's CDx development program, working with Indica Labs on next-generation AI-enabled CDx assays. Leica Biosystems' CDx development program, currently based out of Centers for Enabling Precision Medicine in the United Kingdom and the United States, partners with pharma companies globally to help unlock patient access to novel cancer therapies.

"This is a truly groundbreaking partnership designed to accelerate the advent of next-generation AI-enabled solutions in cancer diagnostics," said Gustavo Perez-Fernandez, President of Leica Biosystems. "Leica Biosystems is proud to partner with Indica Labs to develop and deliver a world-class computational pathology solution to customers and their patients. The opportunities for innovation are endless with our Aperio GT 450 DX and Indica Labs' HALO software for image management."

Indica Labs CEO Steven Hashagen commented, "we are delighted to team up with Leica Biosystems under this exciting arrangement. 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. 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."

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 USA 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.

Piper Sandler & Co. served as Indica Labs' exclusive strategic advisor.

About Leica Biosystems

Leica Biosystems is a cancer diagnostics company and a global leader in a global leader in anatomic and digital pathology solutions. The company offers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. As the only company to own the full workflow from biopsy to diagnosis, Leica Biosystems is uniquely positioned to break down the barriers between each step. The company's mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of its corporate culture. Leica Biosystems is proud to be a Danaher Corporation subsidiary.

Leica Biosystems refers to Leica Biosystems Imaging, Inc. 

About Indica Labs

Indica Labs is the global leader in AI-powered digital pathology software and services. Our flagship HALO® and HALO AI platform revolutionizes quantitative evaluation of whole slide images. HALO Link provides collaborative image management while HALO AP® and HALO AP Dx deliver enterprise digital pathology for primary diagnosis with regulatory clearances in multiple markets. Through a commitment to open pathology, performance, scalability, and ease-of-use, we help pharma companies, diagnostic labs, hospitals, research organizations, and Indica's own Cloud and Pharma Services make discoveries and diagnoses that transform patient care and scientific discovery.

SOURCE Leica Biosystems