Ibex Medical Analytics, the global leader in clinical-grade AI-powered pathology, today announced a significant expansion of its biopharma business. Building on its successful collaborations in late-stage biomarker development, Ibex is now extending its platform into earlier translational research, biomarker development, and trial-efficiency optimization.

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Ibex's platform now extends to earlier translational research, biomarker development, and trial-efficiency optimization

Ibex’s high-performance AI platform—already deployed across more than 50 health systems worldwide and used in collaboration with major industry organizations such as Philips and Roche—now supports exploratory, preclinical, and clinical evidence generation, while providing a seamless foundation for future companion diagnostic (CDx) programs.

"In an era where modalities like antibody-drug conjugates (ADC), immune-modulating agents, and molecularly guided therapies are reshaping oncology, the field needs biomarkers that match the complexity of our treatments and enable adequate patient selection”, says Paolo Tarantino, M.D., Research and Clinical Fellow at Dana-Farber Cancer Institute and Harvard Medical School. “AI-based biomarker platforms can integrate multiple dimensions of cancer biology in a rapid, objective, and reliable way, offering a terrific opportunity to enhance treatment tailoring. This platform has the potential to transform both early and late drug development, further accelerating drug development and ensuring precision in oncology."

New Analytical Modules

Ibex will be introducing new and expanded AI modules relevant to high-priority therapeutic areas, such as:

• HER2 Low & HER2-Ultra-Low quantification: new data showing Ibex’s AI tools enrich true amplified cases in the equivocal range was presented at the San Antonio Breast Cancer Symposium on December 12.
• Tumor microenvironment analysis of rare histologic subtypes of common cancers (e.g. prostate cancer, breast cancer).
• Emerging AI-based biomarkers underpinning antibody-drug conjugates (ADC), bispecific antibodies, and various immune-oncologic strategies.

These modules are developed under ISO 13485-aligned design control, in an IVD-ready architecture, and supported by fully versioned pipelines and audit trails that meet global regulatory expectations.

“Pharma needs partners that can support biomarker innovation from the earliest exploratory work to fully regulated CDx programs. With our proven execution in late-stage development including FDA and CE-IVDR clearances, and as we strengthen our translational capabilities, we are uniquely positioned to accelerate drug development pipelines and improve evidence quality worldwide,” remarks Joseph Mossel, Co-Founder & CEO, Ibex Medical Analytics.

A Platform Built for Security, Scale, and Global Deployment

With next-generation enterprise security, validated through detailed big-pharma due diligence—including IT security, supplier risk, and privacy assessments, the system can be deployed in dedicated virtual private clouds, on-prem, hybrid, or air-gapped environments and is compatible with leading WSI scanners, DICOM-DP infrastructure, HL7/FHIR workflows, and structured outputs for regulated trial endpoints.

Learn more at: https://ibex-ai.com/biopharma/

About Ibex Medical Analytics

Ibex is a global leader in clinical-grade AI for pathology, with deployed solutions in over 50 health systems and partnerships spanning life-science companies, reference laboratories, and digital pathology vendors. Ibex’s platform supports biomarker discovery, clinical trial efficiency, and CDx-ready evidence generation, backed by an ISO 13485-compliant QMS.

The Ibex platform includes solutions that are CE-IVD certified and registered with the UK MHRA, TGA in Australia and ANVISA in Brazil. It includes a solution that is FDA cleared and others that are Research Use Only (RUO) in the United States.

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“This platform has the potential to transform both early and late drug development, further accelerating drug development and ensuring precision in oncology." - Paolo Tarantino, M.D., Research & Clinical Fellow at Dana-Farber Cancer Institute