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.

Learn More About NAMs