Xsphera Platform
Human Tissue is the Best Predictor of Human Response
Animal models have proven to be insufficient for predicting human response to cancer drugs. Xsphera overcomes these limitations with a human tissue-based platform that accurately captures the dynamic response of the tumor microenvironment across the diversity of patients.
90% Of Oncology Drugs
Fail Clinical Trials
We confront a critical issue in oncology drug development: the overwhelming majority of new drugs fail to obtain regulatory approval. This creates immense stress for the medical community and obstructs the evaluation of other promising treatments. As a consequence, billions of dollars are wasted, and patients are left with limited options for care.
It’s Time for a Better Approach
Xsphera’s tumor tissue platform reveals the variability of human response
before clinical trials.
Our patented system uses fresh human tissue to create spheroids that preserve each patient’s unique tumor microenvironment. Spheroids are loaded into microfluidic devices and independently treated with multiple therapies.
Multi-omic response data is automatically integrated in a cloud analytics platform that informs every step of the drug development process.
A New Era for Human-Relevant Drug Testing
Regulatory Shift: FDA & Congress Embrace Human-Relevant NAMs
Recent U.S. legislative action and coordinated federal agency initiatives are reshaping the regulatory landscape — accelerating the adoption of New Approach Methodologies (NAMs) and highlighting the growing importance of human-relevant testing platforms like Xsphera’s.
- FDA Modernization Act 3.0 (FDAMA 3.0): In December 2025, the U.S. Senate unanimously advanced legislation directing the FDA to update testing language and expectations, moving beyond prescriptive animal testing requirements toward flexible, science-driven approaches that enable human-relevant methods such as NAMs.
- Xsphera Platform Alignment: Xsphera’s ex vivo, human tissue-based platform embodies the core principles of a New Approach Methodology, providing human-relevant biology and high-content mechanistic insights that directly support translational and early-stage drug development goals while aligning with the evolving priorities of both the FDA and NIH.
From Response Data to AI-Powered Predictions and Insight
AI-powered modeling of patient tumors with Xsphera’s Virtual Tumor Model
The Virtual Cell Initiative has catalyzed a growing body of research exploring whether AI can learn and predict biological response from large-scale perturbation data. While the field is still evolving, there is broad consensus that predictive performance improves as models are trained on richer, higher-quality experimental datasets.
Our Virtual Tumor model extends this direction to real human tumor tissue, training AI models on thousands of patient samples exposed to multiple therapies with dynamic transcriptomic readouts.
Xsphera’s Virtual Tumor (XVT) enables:
- Prediction of mono and combination therapy response from patient’s untreated RNA expression profile
- Learning of resistance, pathway activation, and temporal dynamics across different patient samples and indications
- What-if simulation to accelerate drug development and patient stratification
Xsphera Ex Vivo Tumor Tissue and Cloud
Computing Platforms
Assess multiple drug responses on each patient’s tumor microenvironment
Cloud-based software analyzes sample data and treatment responses
Unlock the complexity of each patient response with cloud-based analytics
Get Started with Xsphera
No kits. No tumor procurement. No complex training.
Xsphera understands the importance of transparency and collaboration in drug development. Our team is here to support your team with study design, execution and analysis. We seamlessly integrate as an extension of your team, providing collaboration and transparency throughout the process.
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26 Landsdowne Street
Cambridge, MA, 02319 — ALL RIGHTS RESERVED