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 tissues and cells. 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 cells and tissues. 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

Panakeia Unveils Landmark Metabolic and Pathway Activation Data in Cancers at AACR 2026

CAMBRIDGE, UK — April 21, 2026 — Panakeia (“the Company”), the world’s first in silico multi-omics company, today unveiled landmark pathway activation data in cancers at the American Association for Cancer Research (AACR) Annual Meeting 2026, further proving its unique capability to unlock complete biological blueprints essential for drug discovery and clinical decision-making.

The Company revealed that its PANProfiler platform successfully determines functional metabolic hallmarks—the essential pathways that fuel cancer growth—directly from routine brightfield images. This data, building on findings presented earlier in the week, demonstrates that the PANProfiler platform can identify functional biological states that drive patient response, revealing instances where patients may not respond to therapy despite having a positive biomarker status or expression of a drug target. Unlike current industry efforts that remain at the level of hypothesis, Panakeia is actively proving the biological basis of these insights, moving beyond binary results to provide a "functional blueprint." By uncovering these biological blueprints that would otherwise require multiple, disparate wet-lab experiments to correlate, the PANProfiler platform establishes a new standard for the field, replacing the limitations of traditional testing to improve the accuracy of patient selection and, ultimately, patient outcomes.

Metabolic reprogramming is a recognized hallmark of cancer yet reliable assessment of a tumor’s metabolic state remains a significant challenge due to the reliance on specialized workflows, fresh tissue requirements, and high costs. The PANProfiler platform overcomes this “assessment gap” by analyzing the biology of cells and tissues to deliver a complete biological blueprint. Because this process is non-destructive, it preserves valuable samples while accelerating drug discovery and elevating the precision of clinical decision-making.

Study Highlights and Clinical Relevance:

• Unprecedented Scope: The study evaluated 450 pathway-cancer models across 21 different cancer types, utilizing data from The Cancer Genome Atlas (TCGA).

• Robust Determination: Results demonstrate that 87% of the metabolic pathway models were successful in determining activity from routine images, with 9% showing particularly strong performance (AUC > 0.65).

• Actionable Therapeutic Insights: The platform demonstrated a consistent ability to determine activity in key pathways that are existing therapeutic targets, including consistent Nucleotide Metabolism, Nuclear Transport (XPO1), and Fatty Acid beta-oxidation enrichment across multiple cancers.

• Scalable Stratification: By determining these functional states from the routine image alone, Panakeia provides a non-destructive complement to traditional molecular profiling, paving the way for biomarker-driven trial enrichment at scale.

Pahini Pandya, Chief Executive Officer and Founder at Panakeia, commented: “Our presence at AACR this year marks a pivotal step in our mission to unlock complete biology at scale, providing a new level of biological resolution that allows biopharma partners to identify novel targets and accelerate the development of precision therapies while simultaneously making the highest standard of precision medicine accessible to patients and doctors worldwide. By determining these functional metabolic states directly from routine images of tissues and cells, we are ensuring both drug developers and clinicians have the tools to reduce failure rates and improve patient outcomes across the entire life cycle of a drug and the patient journey respectively. 

“Panakeia’s technology enables us to uncover biological truths—such as the unexpected disagreement between clinical status and actual pathway activation seen in our HER2 study—that remain invisible to the human eye and traditional testing. By grounding our AI in a biology-first approach, we are unlocking the insights necessary to transform the future of healthcare and drug discovery, making precision diagnostics a global reality.”

Regulatory-approved clinical products leveraging Panakeia’s technology are already deployed in hospitals globally. This deployment is supported by rigorous independent validation, as the company continues to set the gold standard in healthcare AI through ongoing work with regulatory bodies, including the MHRA and FDA.

Presentation Details:

Oral Presentation:

• Session: Minisymposium: Machine Learning Approaches for Cancer Diagnosis and Treatment Prediction

• Presentation Title: A translational deep learning platform determines metabolic pathway activity from routine H&E slides to enable patient stratification

• Presenter: Dr. Pahini Pandya

• Time: April 21, 2026, 2:30 PM – 4:30 PM PST

• Location: Ballroom 20 CD - Upper Level - San Diego Convention Center

Poster Presentation (Presented April 19):

• Poster Title: Functional pathway analysis reveals discordance between clinical HER2 status and downstream effector activation in breast cancer

• Session Title: Application of Bioinformatics to Cancer Biology 1

• Location: Poster Section 3, Board Number 19

For more information please contact:

Stella Lempidaki, PhD

Head of Communications

contact@panakeia.ai

About Panakeia Panakeia is the world's first 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 PANProfiler platform uses a biology-first AI approach to determine biomarker status across DNA, RNA, proteins, and metabolites directly from routinely used brightfield images of tissues and cells.

The PANProfiler platform has been independently validated in peer-reviewed publications, including Nature Communications Medicine, where it was recognised as one of the journal's top 25 papers of 2024. Two UKCA-marked clinical products derived from the platform are deployed in hospitals, enabling faster and more accessible precision diagnostics.

To learn more about Panakeia's platform visit: https://www.panakeia.ai/

Panakeia to attend and present at upcoming scientific and business conferences

Cambridge, UK, 16 April 2026 – Panakeia (“the Company”), the world’s first in silico multi-omics company, is pleased to confirm that it will be attending and presenting at a number of conferences in April and May 2026.

AACR Annual Meeting – April 17 – 22, San Diego, CA

• Oral Presentation

Title: A translational deep learning platform predicts metabolic pathway activity from routine H&E slides to enable patient stratification

Abstract Presentation Number: 6726 Session: Machine Learning Approaches for Cancer Diagnosis and Treatment Prediction

Date/Time: April 21, 2026, 2:30 PM – 4:30 PM PST

• Poster Presentation

Title: Functional pathway analysis reveals discordance between clinical HER2 status and downstream effector activation in breast cancer

Poster Number: 57 (Poster Section 3, Poster Board 19)

Session: Application of Bioinformatics to Cancer Biology 1

Date/Time: April 19, 2026, 2:00 PM – 5:00 PM PST

The NHS Strategy Summit – April 30, London, UK

Annual Transforming Digital Pathology & AI: The Path Forward – May 14, Edinburgh, UK

• Company Presentation: Joint presentation delivered alongside one of Panakeia’s clinical partners.

  
  

The Times Life Sciences Summit – May 21, London, UK

Boston Tech Week – May 26 – 31, Boston, MA

ASCO Annual Meeting – May 29 – June 2, Chicago, IL

If you would like to meet with the Panakeia team at any of the above conferences, please get in touch via the contact form on our website.

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About Panakeia

Panakeia is the world's first 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 PANProfiler platform uses a biology-first AI approach to determine biomarker status across DNA, RNA, proteins, and metabolites directly from routinely used brightfield images of cells and tissues. The PANProfiler platform has been independently validated in peer-reviewed publications, including Nature Communications Medicine, where it was recognised as one of the journal's top 25 papers of 2024. Two UKCA-marked clinical products derived from the platform are deployed in hospitals, enabling faster and more accessible precision diagnostics.

To learn more about Panakeia's platform visit: https://www.panakeia.ai/

For more information please contact:

Stella Lempidaki, PhD

Head of Communications

contact@panakeia.ai