---
title: Clinical Validation
description: Clinical Validation
---

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# Clinical Validation

## What Clinical Validation Does the CNSide® CSF TCE Test Have?

- **Publications **  9+ peer-reviewed publications with several under review (as of January 2025).
- **Sensitivity   **CNSide has shown a 92% sensitivity in detecting tumor cells in patients with LM. [Source](https://aplm.kglmeridian.com/view/journals/arpa/149/3/article-p242.xml)
- **Specificity   **CNSide has shown a 95% specificity with no tumor cells detected in patients without LM. [Source](https://aplm.kglmeridian.com/view/journals/arpa/149/3/article-p242.xml)
- **Economic Value**   A cost-of-care analysis abstract was recently published by The Professional Society for Health Economics and Outcomes Research (ISPOR). This abstract stated that "CNSide may reduce overall LM-related costs by ~40% (33%-47%), driven by earlier intervention, prolonged life expectancy, improved treatment precision, reduced adverse events and hospitalizations, and QALY gains." [The full abstract can be found here. ](https://www.ispor.org/heor-resources/presentations-database/presentation-cti/ispor-2026/poster-session-5-3/economic-impact-of-earlier-detection-and-therapeutic-management-of-leptomeningeal-metastases-using-cnside-a-cost-of-care-analysis)

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© 2026 CNSide Diagnostics, LLC is a subsidiary of Plus Therapeutics, Inc. CNSide is a trademark of CNSide Diagnostics, LLC. All rights reserved.

The intended use of this test is to establish the presence and quantity of tumor cells in cerebrospinal fluid specimens of patients with Leptomeningeal Disease. This test was developed and its performance characteristics determined by CNSide Diagnostics LLC. It has not been cleared or approved by the FDA. This test is used for clinical purposes and should not be regarded as investigational or for research. CNSide Diagnostics laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.