Indica Labs

Albuquerque, New Mexico, USA  All Mexico companies → Founded 2011
Point-of-Care Diagnostics
Pathology
Pathology AI
Privately Held / Profitable — Undisclosed (company reports organic growth without external investment)

Products

HALO AP Dx
Indica Labs
Pathology AI
HALO AP Dx is an FDA-cleared enterprise digital pathology platform by Indica Labs, enabling primary diagnosis, remote working, and streamlined workflows for anatomic pathology in conjunction with specific FDA-cleared slide scanners.

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About Indica Labs

Indica Labs is a global leader in AI-powered digital pathology software and services, providing comprehensive solutions for quantitative evaluation and management of whole slide images. Their flagship platforms, HALO® and HALO AI, leverage artificial intelligence and computer vision algorithms to enable fast and precise analysis of tissue samples, which is critical for advancing research and diagnostics in various medical fields.

For physicians, Indica Labs’ offerings, including HALO AP® and HALO AP Dx, are designed to streamline diagnostic workflows, enhance accuracy, and facilitate collaboration in anatomic pathology. These platforms have received regulatory clearances in multiple markets for primary diagnosis and support high-throughput, whole-slide tissue analysis across diverse areas such as immuno-oncology, oncology, transplant science, neuroscience, ophthalmology, metabolism, respiratory, and tox pathology. The company also provides specialized Pharma Services, offering quantitative image analysis studies, including those compliant with Good Clinical Practice (GCP) standards, to support pharmaceutical companies, diagnostic labs, and research organizations in their biomarker programs and companion diagnostics development.

Focus Areas

Digital pathology AI-powered image analysis image management life sciences research clinical diagnostics precision medicine companion diagnostics (CDx) development quantitative evaluation of whole slide images immunohistochemistry (IHC) fluorescence in situ hybridization (FISH) in situ hybridization (ISH) chromogenic in situ hybridization (CISH) oncology immuno-oncology neuroscience infectious disease metabolism

Business Intelligence

Key InvestorsLeica Biosystems (strategic investment)
PartnershipsLeica Biosystems (strategic investment, exclusive reseller of IMS products, CDx development), Paige (integration of Diagnostic AI models into HALO AP®), Amazon Web Services (AWS) (cloud services, deep archive module, APN member), Hamamatsu Photonics K.K. (FDA clearance for HALO AP Dx with NanoZoomer® S360MD Slide scanner), Histofy (integration of AI tools into HALO AP®), Lunit (integration of Lunit SCOPE PD-L1 into HALO AP®)
TechnologyHALO® (image analysis platform), HALO AI (deep learning classification and segmentation), HALO Link (collaborative image management), HALO AP® (enterprise digital pathology for clinical workflows), HALO AP Dx (FDA-cleared for primary diagnosis), Cloud Services (AWS hosted), AI-native digital pathology platform, deep learning, computer vision, open pathology, APIs, DICOM compatibility
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Digital Pathology & AI-powered Image Analysis
Indica Labs is a global leader in AI-powered digital pathology, offering the HALOu00ae suite of software for comprehensive image analysis. Their platforms enable standardized, pixel-level analysis of whole slide images.
Image Management & Workflow Solutions
They provide robust image management through HALO Link for collaborative research and HALO APu00ae / HALO AP Dx for enterprise anatomic pathology workflows, including primary diagnosis, remote working, and clinical trial management.
Life Sciences Research & Drug Development
Their platforms support life science discovery, translational research, and accelerate drug development by providing tools for image evaluation, collaboration, and clinical trial management.
Clinical Diagnostics & Precision Medicine
Indica Labs offers FDA-cleared (HALO AP Dx) and CE-IVDR marked (HALO APu00ae) platforms for primary diagnosis, enhancing diagnostic accuracy and supporting precision medicine through objective biomarker quantification.
Companion Diagnostics (CDx) Development
They specialize in companion diagnostics development, transforming precision medicine through AI-powered pathology, including partnerships for comprehensive CDx development.
Quantitative Evaluation of Whole Slide Images
A core specialization is the precise, quantitative evaluation of whole slide images across various assays, including immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and in situ hybridization (ISH).
Key Differentiators
Indica Labs stands out as a global leader in AI-powered digital pathology, committed to an 'open pathology' ecosystem that ensures scanner agnosticism and seamless integration with third-party AI and LIS/LIMS systems. Their comprehensive HALO suite offers user-friendly, scalable, and cloud-hosted (AWS) solutions, including FDA-cleared and CE-IVDR platforms for clinical use.
Technology Stack
Their technology stack centers around the HALO software suite (HALO, HALO AI, HALO Link, HALO AP, HALO AP Dx), leveraging deep learning and machine learning for AI-powered image analysis. They utilize AWS for cloud hosting, offer robust APIs for integrations, and support a wide array of image file formats from all leading scanner manufacturers.
Physician Tip

For physicians, Indica Labs' platforms significantly enhance diagnostic accuracy and efficiency through AI-powered quantitative analysis and streamlined workflows. The user-friendly interface makes reviewing complex cases and collaborating with colleagues much easier, especially for multidisciplinary team meetings like tumor boards. Their FDA-cleared HALO AP Dx and CE-IVDR marked HALO APu00ae provide confidence for primary diagnosis and enable remote work capabilities. The objective, pixel-level quantification of biomarkers is crucial for precision medicine and guiding targeted therapies. Furthermore, their commitment to an open ecosystem allows seamless integration of best-of-breed AI tools and existing LIS/HIS, empowering pathologists with choice and flexibility.

Indica Labs is dedicated to 'open pathology,' ensuring their HALO platforms are scanner agnostic and support a wide array of image file formats. They actively partner with leading image analysis and AI developers, including Lunit, Paige, Ibex Medical Analytics, and Visiopharm, to seamlessly integrate third-party AI solutions. Their platforms also offer deep expertise in custom integration and database migration, unifying diverse data streams into interoperable workflows with existing LIS/LIMS systems.

Products by Indica Labs

1 product in the directory

HALO AP Dx
Indica Labs
Pathology AI
HALO AP Dx is an FDA-cleared enterprise digital pathology platform by Indica Labs, enabling primary diagnosis, remote working, and streamlined workflows for anatomic pathology in conjunction with specific FDA-cleared slide scanners.

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Press & Coverage

Indica Labs
Indica Labs Introduces the HALOu00ae ADC Target Scoring Module, Advancing Antibody-Drug Conjugate Development
Indica Labs launched the HALOu00ae ADC Target Scoring module to support the development of next-generation precision oncology therapies through quantitative target scoring and spatial analysis. This new functionality aims to advance antibody-drug conjugate development.
2026-07
Indica Labs
Indica Labs Advances Breast Cancer AI with Zero-Click Tissue Classification Prior to Biomarker Analysis
Indica Labs announced new intelligent tissue classification capabilities for HALO Breast IHC AI, its AI-powered breast biomarker quantification suite. This enhancement introduces automated identification and exclusion of various tissue types before biomarker analysis, streamlining the process.
2026-07
Indica Labs
HALO AP 2.5 Advances Digital Pathology with Enhanced Automation, Collaboration, and Scalability
Indica Labs released a new software version, HALO AP 2.5, designed to streamline and scale digital pathology workflows. The update focuses on enhanced automation, collaboration, and system transparency.
2026-07
Indica Labs
Indica Labs Expands into Prostate Cancer, Improving NGS ConfidenceThrough Precise Tumor Quantification
Indica Labs launched Prostate Macrodissect AI, a clinically validated algorithm to automate and quantify tumor content in FFPE prostate tissue specimens. This expansion aims to improve NGS confidence through precise tumor quantification.
2026-06
Indica Labs
Indica Labs Unveils AI-Powered Companion Diagnostics Offering Ahead of ASCO 2026
Indica Labs announced a major expansion of its companion diagnostics (CDx) capabilities, positioning the company at the forefront of precision medicine innovation. The offering leverages advanced AI models integrated into their digital pathology platforms.
2026-05
Indica Labs
Indica Labs Receives FDA Clearance for Enterprise Digital Pathology Platform with Industry Leading DICOM-Compatible Aperio Scanner from Leica Biosystems
Indica Labs and Leica Biosystems received FDA 510(k) clearance for the HALO AP Dx enterprise digital pathology platform in conjunction with the Leica Biosystems Aperio GT 450 DX Scanner for in-vitro diagnostic use.
2025-12
PR Newswire
Indica Labs Receives FDA Clearance for HALO AP Dx Digital Pathology Platform for Use with Hamamatsu Images Acquired with the NanoZoomeru00ae S360MD Slide Scanner
Indica Labs and Hamamatsu Photonics K.K. announced that the FDA issued a 510(k) clearance to Indica Labs for HALO AP Dx, an enterprise digital pathology platform, for primary diagnosis when used with the Hamamatsu NanoZoomeru00ae S360MD Slide scanner.
2024-05
American Laboratory
Indica Labs and Lunit Announce a Strategic Alliance for Seamless Integrated Digital Pathology AI Workflows
Indica Labs and Lunit announced an agreement to provide a fully interoperable solution between Indica Labs' HALO APu00ae image management software platform and Lunit's suite of AI pathology products. This collaboration aims to create seamless integrated digital pathology AI workflows.
2023-09

Frequently Asked Questions

Indica Labs provides the HALOu00ae and HALO AIu2122 platforms for quantitative image analysis, enabling detailed evaluation of whole slide images using AI and computer vision algorithms. These platforms support various staining methods like immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), in situ hybridization (ISH), and chromogenic in situ hybridization (CISH), and are applied across diverse research areas including oncology, immuno-oncology, neuroscience, infectious disease, and metabolism.
For clinical diagnostics, Indica Labs offers HALO APu00ae Dx, an FDA-cleared and CE-IVDR marked platform designed for primary diagnosis, remote working, and routine anatomic pathology workflows. Indica Labs also partners with companies like Leica Biosystems to develop AI-powered companion diagnostics, accelerating precision medicine by combining deep AI and biomarker analysis expertise.
Indica Labs offers HALO Linku2122 for collaborative image management and research-focused workflows, and HALO APu00ae for enterprise digital pathology, which enables collaborative clinical case review. These platforms are designed for interoperability, integrating with various scanners, LIS/LIMS, and third-party AI applications, and can be deployed on-premise or in the cloud.
Indica Labs' HALO AP Dx platform is FDA-cleared for primary diagnostic use in the USA with specific scanners and is CE-IVDR marked for in-vitro diagnostic use in Europe, the UK, and Switzerland. The platform also provides built-in compliance with FDA 21 CFR Part 11, HIPAA, and GDPR, and the company is ISO 13485 certified.
Indica Labs offers comprehensive support, including unlimited IT support, scientific support, and training, along with access to their Learning Portal, all included with every license. They maintain a global team of PhD-trained Applications Scientists and Technical Solutions Engineers located in the US, Canada, UK, EU, China, and Japan to provide world-class assistance.
Indica Labs has established strategic partnerships with industry leaders such as Leica Biosystems for accelerating AI-powered companion diagnostics and expanding digital pathology solutions, and Paige and Lunit for integrating advanced AI models. The company, founded in 2011, is privately held, consistently profitable, and has surpassed 3,000 HALO software deployments worldwide, demonstrating strong stability and growth.
Indica Labs offers flexible licensing options for its HALO platforms, including single-seat, multiple-seat, and enterprise licenses, available on an annual or permanent basis. Customers can choose between managing their own local or cloud deployments, or utilizing Indica Labs' Cloud Services for optimized, scalable, and secure hosted environments.

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