Indica Labs, the leading provider of AI-powered digital pathology solutions, proudly announces the launch of Lung Macrodissect AI, a groundbreaking tool that revolutionizes slide macrodissection and molecular pathology workflows.

Lung Macrodissect AI represents a significant leap forward for the integration of artificial intelligence with digital pathology by offering pathologists a streamlined macrodissection workflow that minimizes human error and improves efficiency.

Tumor content estimation and macrodissection are critical steps in molecular pathology, involving the assessment of tumor content within a sample and the precise isolation and removal of tumor regions for downstream molecular analysis. Existing manual methods are subjective, error-prone, labor-intensive, and lack auditability.

Indica Labs’ innovative HALO Macrodissection Solutions suite addresses these challenges by quantifying tumor content across the entire whole slide image and generating real-time information about the quantity of tumor cells within annotated regions. Tumor cell density heatmaps highlight tumor-rich regions, aiding the annotation process. Lung Macrodissect AI quantifies and standardizes tumor content assessment, reducing subjectivity and errors while streamlining the macrodissection annotation process for both primary and metastatic non-small cell lung cancer cases.

Lung Macrodissect AI integrates seamlessly into HALO AP®, the enterprise digital pathology platform from Indica Labs, and can be combined with the Tissector line of robotic macrodissectors from our partner, Xyall, for a fully automated and audited workflow. This integration enhances the accuracy of the macrodissection process and increases throughput and operational efficiency, freeing pathologists to focus on more complex tasks. The tool can also be used to guide and standardize manual macrodissection workflows.

"We’re excited to offer pathologists an alternative to the current time-consuming, labor-intensive process of macrodissection. Our macrodissection AI models significantly advance the field of molecular pathology," said Steven Hashagen, CEO of Indica Labs. "Lung Macrodissect AI is part of a larger suite of macrodissection tools, with additional product launches planned for colon, breast, and prostate. These products significantly enhance macrodissection workflows and make genetic testing more accessible, accurate, and affordable."

Beyond highlighting cancerous tissue, Lung Macrodissect AI calculates the total number of tumor cells present within an annotated region of interest (ROI) and determines the percentage of tumor present in all annotated ROIs. This ensures that only adequately concentrated specimens are sent for expensive downstream genetic sequencing and molecular testing. By standardizing the enrichment process, Lung Macrodissect AI improves the overall quality and reliability of macrodissection workflows while streamlining the process in its entirety and enhancing efficiency.

"The current manual methods of tumor content estimation and macrodissection are subjective and prone to error," said Peter Caie, Senior Principal Scientist in the AI Diagnostics group at Indica Labs. "Pathologists spend a significant amount of time meticulously examining slides and annotating regions of interest by hand, a process that is both tedious and demands immense effort on the part of laboratory staff. Lung Macrodissect AI advances the process of slide macrodissection by accurately and objectively quantifying every cell across a whole slide image, guiding and simplifying the annotation process and automatically reporting the tumor content within said annotation in real-time."

Clinical validation was conducted on 317 primary and metastatic whole slide images from an external site that were previously unseen to the algorithm. Comparing five pathologists’ tumor content estimations with and without assistance from Lung Macrodissect AI revealed significant improvements in agreement and consistency when aided by the algorithm. Without AI assistance, the consistency between pathologists (ICC) was relatively low at 0.45. The agreement measure (Fleiss’ kappa) when specimens were binarized using a 20% tumor content cut-off, the minimum requirement for most molecular tests, was also low at 0.27. With AI assistance, the ICC score increased to 0.75, and the Fleiss’ kappa statistic rose to 0.66, indicating a substantial and significant improvement in consistency of tumor content estimation across pathologists.

Lung Macrodissect AI is available in the HALO AP® platform, trusted for its robust suite of tools for annotation, collaboration, and image analysis. HALO AP® offers seamless interoperability and compatibility with a wide range of file types, LIS | LIMS, and HALO Clinical AI and third-party AI, ensuring flexibility and ease of use in diverse laboratory environments.

Lung Macrodissect AI is not a medical device in the EU/UK and is not intended to be used for diagnostic purposes. Lung Macrodissect AI is accessed via the HALO AP® enterprise digital pathology platform. Lung Macrodissect AI is For Research Use Only in the USA and is not FDA cleared for clinical diagnostic use.

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.

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 a collaborative environment for 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 and a combination of unmatched 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 propel scientific discovery.