Indica Labs Reports 260% Clinical Revenue Growth and Expansion into New Global Markets
The rapid global adoption of HALO AP® prompted immediate localization of the platform in Chinese, Danish, Dutch, American and British English, Finnish, French, German, Greek, Italian, Norwegian, Japanese, Portuguese, Russian, Spanish, Slovakian, and Swedish.
Albuquerque, NM, December 17, 2025 – Indica Labs, the global leader in AI-powered digital pathology, announced today that clinical revenue for HALO AP® is up 260% since 2023 and recurring revenue for 2025 shows a 200% increase year-over-year, reinforcing its position as a market leader in digital pathology diagnostics. The company has been consistently profitable and maintains organic growth trajectories without venture funding, strategically reinvesting in AI innovation and accelerating product development across its clinical portfolio. Their clinical solutions include HALO AP®, a CE-IVDR-cleared, AI-native digital pathology platform; HALO AP Dx, an FDA 510(k)-cleared image management system for primary diagnosis; and a growing suite of AI algorithms for tumor content assessment and biomarker quantification.
In January of 2025, Indica Labs proudly announced a partnership with Leica Biosystems, aligning industry-leading software with high-capacity scanners and positioning both organizations to advance AI-powered companion diagnostic (CDx) development. Leica Biosystems now serves as the exclusive reseller of Indica Labs IMS products.
Regulatory Momentum
Indica Labs’ clinical solutions are seeing accelerated adoption across major medical centers, CROs, integrated delivery networks, and reference laboratories worldwide, driven in part by ongoing regulatory clearances for HALO AP® and HALO AP Dx. The rigorous requirements established by the FDA and CE-IVDR regulations validate the reliability of these platforms and provide a strong foundation for leading pharmaceutical companies and elite healthcare networks to integrate Indica Labs’ digital pathology solutions into routine clinical workflows with confidence.
Global Clinical Adoption and Regulatory Expansion
The company operates on an accelerated development cadence with two major releases each year, allowing new capabilities and workflow improvements to be delivered rapidly. Its clinical platforms already hold regulatory approvals and registrations in the United States, the European Union, the United Kingdom, Switzerland, Saudi Arabia, Thailand, Indonesia, Singapore, Vietnam, and Israel. This expanding regulatory footprint underscores the organization’s readiness for worldwide deployment and has driven the progressive localization of HALO AP®, now available in 17 languages. Together, these capabilities establish a scalable framework that supports consistent care across a wide range of clinical, cultural, and regulatory environments.
“HALO AP Dx is now FDA-cleared for primary diagnosis with the Aperio GT 450 DX Scanner, and we anticipate additional clearances in 2026 as our commitment to advancing patient care accelerates globally,” said Steven Hashagen, CEO of Indica Labs. “Our partnership with Leica Biosystems enhances our ability to execute on the upcoming wave of next-generation computational CDx development.”
Expanding AI Portfolio for Macrodissection and Biomarker Analysis
The company continues to broaden its AI portfolio with macrodissection algorithms for NSCLC and colorectal carcinoma, with breast and prostate solutions launching soon. These workflows enrich tumor cellularity, reduce NGS assay failure rates and improve the overall efficiency and reliability of downstream molecular testing by generating real-time tumor-cell density maps, quantifying tumor and total cells, and guiding optimal ROI selection with unprecedented accuracy.
Their in-house developed suite of AI powered algorithms also include Lung PD-L1 AI and Breast IHC AI for biomarker quantification in lung and breast cancer, respectively, and HALO Prostate AI for cancer detection and Gleason grading of prostate cancer in core needle biopsies.
Open AI Ecosystem and Third-Party Integrations
Indica Labs remains committed to their in-house developed AI algorithms which seamlessly integrate into their enterprise digital pathology platform HALO AP®, while also staying dedicated to open pathology and 3rd party AI integration. Their offering of software development kits (SDKs) and open APIs allows any developer to build and integrate custom AI algorithms. This architecture also enabled successful integrations from AI vendors including Lunit, Paige, Histofy, and IBEX, while their DICOM compliance and scanner agnostic framework further support interoperability.
Looking Ahead
Entering 2026, Indica Labs will continue advancing CDx development while expanding its global footprint through partnership with Leica Biosystems. Together, the companies aim to deliver integrated imaging, AI, and diagnostic solutions that accelerate precision medicine worldwide.
HALO Macrodissection Solutions are not intended to be used for diagnostic purposes and are not regulated as medical devices in the EU/UK. HALO Macrodissection Solutions are For Research Use Only in the USA and are not FDA cleared for clinical diagnostic use. HALO Macrodissection Solutions are accessed via the HALO AP® enterprise digital pathology platform.
Breast IHC AI is For Research Use Only and not intended for clinical diagnostic use. Breast IHC AI is accessed via the HALO AP® enterprise digital pathology platform.
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 AI Prostate is CE-marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. HALO AI Prostate is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use. HALO AI Prostate 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 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.
HALO AP Dx (K252762) is FDA-cleared for primary diagnostic use with the Leica Biosystems’ Aperio GT 450 DX Scanner and Hamamatsu NanoZoomer® S360MD Slide scanner in the USA. In addition, HALO AP Dx provides built-in compliance with FDA 21 CFR Part 11 and HIPAA.
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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.
Media Contact:
Kim Collins