On June 26, 2025, Plus Therapeutics delivered a comprehensive business update for its subsidiary, CNSide Diagnostics, unveiling its strategy to enter the U.S. market with the CNSide CSF assay platform (Source: ir.plustherapeutics.com). This update marks an important step in addressing the urgent need for accurate CNS metastasis diagnostics.

Geographical Launch Plan

The CNSide CSF Tumor Cell Enumeration (TCE) test is scheduled to debut in Texas in the third quarter of 2025, with rapid expansion across additional states through late 2025 and 2026 (Source: GlobeNewswire).

Market Potential and Clinical Significance

CNSide targets a $6 billion U.S. market, based on CNS cancer incidence and projected uptake. The platform tackles a critical diagnostic gap: CNS metastases affect up to 30% of adult cancer patients, yet standard CSF cytology, developed over a century ago, often lacks sensitivity, contributing to delayed or inadequate diagnoses (Source: MedPath).

Proven Clinical Performance

• Over 11,000 CNSide tests have been conducted across more than 200 U.S. cancer institutions since 2020.
• The assay demonstrates 92% sensitivity and 95% specificity, outperforming traditional diagnostic methods.
• Crucially, CNSide has impacted treatment decisions in over 90% of cases, reflecting its practice-changing potential (Source: Nasdaq).

Strategic Infrastructure & Leadership Preparedness

Since the acquisition of CNSide in 2024, Plus Therapeutics has established a centralized laboratory in Houston, set up commercial infrastructure, and assembled experienced leadership to drive commercialization.

What’s Next: Expansion and Additional Assays

Following its Texas debut, CNSide aims to expand nationally by late 2025 and 2026. Plus Therapeutics plans to introduce three additional CSF-based assays over the following months, enhancing its diagnostic offerings.

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