HOUSTON, Sept. 25, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), announced today that it has signed a national agreement with UnitedHealthcare Insurance Company (NYSE: UNH), effective September 15, 2025, covering over 51 million people throughout the United States, to provide the CNSide® Cerebrospinal Fluid Tumor Cell Enumeration laboratory developed test (LDT). The CNSide® CSF Assay Platform supports rapid di ...

Certification critical to broad U.S. market release of the CNSide CSF Assay Platform CNSide now meets key federal and state regulatory requirements, including those set by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Lab Improvement Amendments (CLIA) HOUSTON, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted rad ...

Core Insights - Plus Therapeutics, Inc. announced positive data from the ReSPECT-LM Phase 1 trial, demonstrating a clinical benefit rate of over 75% in three relevant outcome measures for the treatment of leptomeningeal metastases with REYOBIQ [1][2] - The trial showed no dose-limiting toxicities and an overall favorable safety profile, indicating the treatment is feasible and effective [1][4] Study Details - The Phase 1 trial involved 29 subjects across six cohorts receiving varying doses of REYOBIQ, ranging from 6.6 mCi to 75 mCi [2] - Early cohorts exhibited excellent tolerance at higher doses, supporting a broad therapeutic range [4] Efficacy and Safety - The study reported a radiographic response rate of 76% and a clinical response rate of 87% through day 112 [6] - CSF tumor cell enumeration assays showed a maximum reduction of 100% at day 28, with a median overall survival of 9 months across the first four cohorts, which is significantly better than the typical 2-6 months reported in literature [6] Future Directions - The trial results provide a foundation for moving into ongoing dosing optimization and potential approval trials [4] - REYOBIQ is being evaluated for multiple CNS cancers, including recurrent glioblastoma and pediatric brain cancer, with significant funding support from the National Cancer Institute and the Cancer Prevention & Research Institute of Texas [5][7]

Core Insights - Plus Therapeutics is set to launch its CNSide CSF Assay Platform in the U.S. market in the second half of 2025, targeting a significant unmet need in CNS cancer diagnostics with a market opportunity exceeding $6 billion [1][2][4] Company Overview - Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics for central nervous system (CNS) cancers [14] - The company has invested over $300 million in the CNSide technology, which aims to address the clinical need for better diagnostic tools in CNS cancer [3] Product Details - The CNSide CSF Assay Platform is designed for patients suspected of having CNS cancer metastases, with the first test, CNSide CSF Tumor Cell Enumeration (TCE), expected to be commercialized soon [2][4] - The platform has demonstrated high sensitivity (92%) and specificity (95%) in diagnosing CNS metastases, influencing treatment decisions in 90% of cases [5] Market Opportunity - CNS metastases affect approximately 30% of adult cancer patients, and the current standard of care for diagnosis is outdated, leading to missed or delayed diagnoses [4] - The CNSide platform is positioned to provide superior clinical utility compared to the current standard of care, which has been validated through real-world use and peer-reviewed publications [5] Commercial Strategy - Plus Therapeutics has established a scalable testing laboratory in Houston, TX, and is executing a commercial market access strategy that includes state licensure and reimbursement codes [6][7] - The company anticipates launching the CNSide platform in Texas first, followed by expansion into additional states [6] Financial Outlook - The revenue contributions from the CNSide subsidiary are expected to become meaningful to Plus Therapeutics' operations in fiscal year 2026 [9]