Formalizing the boundaries between predictive manifold modeling and clinical decision-making. Version 26.1 Build 0x771A.
The Zenith Platform is intended solely for Computational Target Prioritization and In-Silico Protocol Optimization in pre-clinical longevity research.
"The system facilitates the identification of high-probability therapeutic targets by modeling transcriptomic trajectories using Neural Stochastic Differential Equations (Neural SDEs). It provides a decision-support framework to reduce cycle time in wet-lab validation."
Status: Research Use Only (RUO). Not for use in diagnostic or therapeutic procedures.
Algorithm Stability Audit
External audit of Neural SDE solver stability across 1,000+ stochastic seeds. Alignment with HCA V3 benchmarks.
Retrospective Manifold Matching
Publication of cross-dataset validation study comparing Zenith predictions to actual wet-lab outcomes from partner datasets.
Q-Submission Pre-consultation
Engagement with regulatory bodies to define the Software as a Medical Device (SaMD) pathway for future diagnostic modules.
GDPR/HIPAA compliant data ingestion layers. All training data is anonymized and source-verified.
Initial ISO 13485 framework adoption for software development lifecycle (SDLC).
Internal Scientific Review Board (SRB) approved for Pilot Batch v26.1.
Download the full regulatory package for institutional review.
Note: This document reflects current internal policy and is subject to revision based on evolving regulatory frameworks for AI in biological research.