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PathKOL
Best in class pathology scoring platform for clinical trials

PathKOL digital reporting system (DRS) software platform allows access to global experts in clinical trials histological endpoints, also known as central reading. This is a crucial component to the success of clinical trials requiring tissue analytics. The real power behind PathKOL is vertical integration with a state of the art, AI-enabled, laboratory with biomarker quantification coupled with high quality, consistent histology in a CLIA/CAP regulated environment. These factors help to de-risk clinical trials biopsies.

Our Services

Providing you direct access to pathology experts

Pharmaceutical and biotechnology industries: We provide histology support for early stage, Phase 2 and Phase 3 clinical trials. Our recommendation is to engage in partnerships with disease and organ specific expert pathologists as early as possible in the project as this can be key for integrating and developing clinically relevant endpoints and companion biomarkers. Digital pathology and AI integration of biomarkers is important for enhancing detection of therapeutic responsivity via quantitation. We partner with established top pharmaceutical companies and also biotech and pharma startups to help ensure their ultimate success. Clinicians: Specialist pathology services are underutilized and can be critical for enhancing your practice quality and performance. Integration of AI-enabled cutting edge diagnostics can also improve competitiveness.

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Enhanced
Specialist-Only Anatomic Pathology

One of the keys to the best clinical care is subspecialty pathologist support. Clinical trials benefit from deep understanding of disease processes.

Biomarker Development

Biomarkers should be clinically relevant and integral to the disease process and its targets. We independently develop novel disease biomarkers or can partner with your existing pre-clinical or clinical program.

Clinical Trials Histology

Our labs are focused on histological (tissue-based) clnical trials endpoints. Examples include tissue fibrosis, inflammation, or specific protein and nucleic acid markers. Endpoints can be enhanced via digitalization and quantification of biomarkers.

Digital Pathology

We use state-of-the-art digital pathology systems to support collaboration, data transfer, and integration with artificial intelligence (AI) digital image analysis and machine learning techniques.

Pathology Central Reading and Consulting

We have deep expertise in clinical trials pathology central reading for histologic endpoints. We are capable of individual, group (consensus), and real-time reads for rapid recruitment and resulting. We also develop novel scoring systems, manage labs, and provide general pathology consultation.

Histology and Microscopy Research Core

Our lab performs standard histological techniques in a CLIA/CAP regulated environment. In addition, we have both standard and advanced microscopy solutions to support both traditional and digital biomarker development.

“Pathology Institute's consensus platform facilitates pathologist agreement during assessment and scoring NAFLD and NASH for clinical trials and improves discrimination of ballooned hepatocytes."

Dr. Cynthia Behling, M.D., Ph.D.

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Ready to find out more?

Contact us below to get a free assessment of your project and find out more information on how we can support you with our expertise in pathology.

Contact

Contact Us

Thanks for reaching out! We will be in touch shortly.

Central US - Texas:

Galleria Village and Physicians Centre, Bryan, TX 77802

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West Coast US - California:

Eastgate Mall, San Diego, CA  92121

Tel. 1-979-321-6290

© 2026 by Pathology Institute, Inc. All rights reserved.

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