New Multi-Site Validation Study Published by Panakeia Reinforces Scalability of AI Multi-Omics Platform

Study confirms diagnostic-grade performance of PANProfiler Breast (ER, PR, HER2) from routine brightfield images; establishing the technology as a scalable foundation for oncology across multiple cancer types and biomarkers

Cambridge, UK, September 8, 2026 — Panakeia, a world-leading in silico multi-omics company, today announced the publication of a multi-site clinical validation study in Clinical Breast Cancer. The research demonstrates that its PANProfiler Breast (ER, PR, HER2) software, a UKCA-marked medical device, accurately identifies critical molecular biomarkers (ER, PR, and HER2) directly from routine brightfield images of tissues and cells across multiple sites.

This research is an important milestone as it proves that Panakeia's technology works reliably in clinical practice regardless of variations in tissue preparation or image quality across different laboratories. Crucially, it confirms that the platform's core ability to detect biomarkers directly from routine brightfield images translates across multiple cancer types, laying a strong foundation for widespread clinical use.

These findings build upon the platform's established success in colorectal cancer (PANProfiler Colorectal), published in npj Digital Medicine. That study proved the platform matches gold-standard accuracy for both MSI (DNA) and MMR (protein) biomarkers, operates robustly across multiple clinical sites, and delivers results in a significantly faster timeframe.

By also demonstrating similar high-performance molecular profiling in breast cancer, Panakeia has confirmed the platform's capability to deliver consistent, diagnostic-grade insights across diverse cancer types and biomarker classes. The technology is proving to be a scalable foundation for oncology, capable of uncovering complete biological blueprints across any major indication. Unlocking these total biological blueprints directly from routine imaging provides biopharma researchers with the insights needed to accelerate target discovery, while empowering clinicians to match patients to effective targeted therapies faster.

Pahini Pandya, Founder and Chief Executive Officer of Panakeia, commented: "The publication of this study is another important milestone in our journey to make the highest standard of precision medicine accessible to doctors and patients across the world. By proving that we can deliver diagnostic-grade biological insights from routine brightfield images, we are providing the essential tools needed to transform clinical decision-making and ensure patients receive personalized, life-saving therapies without delay.

Our preliminary results recently presented at AACR 2026 show where this is headed—moving beyond these static biomarkers to uncover the functional hallmarks of cancer. By providing this total biological blueprint, we are not only improving care today but providing biopharma partners with the insights needed to accelerate drug development and reduce failure rates in the clinic."

Diagnostic-Grade Performance and Standalone Clinical Utility

• Standalone Diagnostic Capability: PANProfiler Breast (ER, PR, HER2) delivers a high test-replacement rate with strong concordance to gold-standard pathology results, moving the technology beyond a screening aid to a repeatable, reproducible tool for standalone molecular profiling.
• Rapid Molecular Insights: The software provides a digital alternative to traditional "wet-lab" assays, delivering equivalent insights in minutes rather than weeks without requiring additional tissue destruction. For patients and clinical care teams, this drastically reduces anxious waiting periods, preserves limited tissue samples, and provides immediate clarity on next steps and targeted therapy pathways.
• Real-World Reliability: Validation across multiple independent healthcare institutions proved consistent performance even when routine brightfield images were processed on different types of digital scanners.
• Improved Patient Stratification: The AI identified opportunities for more refined patient stratification by uncovering biological nuances that traditional testing may miss. These findings, previously presented at SABCS, AACR, and ESMO Breast, ensure more patients can be matched to the right targeted therapies.

Setting the Gold Standard for Healthcare AI

Having demonstrated the robust performance and scalability of both clinical products and the underlying platform, Panakeia is leading the industry in establishing rigorous evidence standards for safe, patient-centric AI. The company is actively working with international regulatory bodies and industry partners, including participation in the Friends of Cancer Research Digital PATH Project alongside the FDA, and the UK MHRA's AI Airlock programme, to define regulatory roadmaps and safely bring AI-driven diagnostic solutions to patients worldwide.

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About PANProfiler Breast (ER, PR, HER2)

PANProfiler Breast (ER, PR, HER2) is a UKCA-marked AI software powered by Panakeia's proprietary technology that determines ER, PR, and HER2 biomarker status directly from routine brightfield images of cells and tissues. Built using a biology-first approach with AI trained on petabytes of population-scale data, the software provides diagnostic-grade results in minutes, enabling faster treatment decisions and improved patient stratification without the need for additional wet-lab assays.

About the PANProfiler Platform

The PANProfiler platform is a software platform powered by Panakeia's proprietary AI technology that determines multi-omic biomarker status across DNA, RNA, proteins, and metabolites directly from routine brightfield images of tissues and cells. Built using a biology-first approach, the platform can profile thousands of biomarkers in more than 30 cancer types, supporting drug discovery, clinical development, and patient care.

About Panakeia

Panakeia is a world-leading in silico multi-omics company, building AI solutions to uncover complete biology at scale and accelerate precision medicine research, drug discovery, development and clinical decision-making. Panakeia's technology has been independently validated in peer-reviewed publications, including Nature Communications Medicine and Clinical Breast Cancer. Two UKCA-marked clinical products derived from the platform are deployed in hospitals, enabling faster and more accessible precision diagnostics.

For more information please contact:
Stella Lempidaki, PhD
Head of Communications
contact@panakeia.ai