1. CNSide Diagnostics now licensed to operate in California, Rhode Island, and Maryland. 2. CNSide CSF testing available in 48 states, enhancing patient access. 3. The CNSide® CSF Assay shows high sensitivity (92%) and specificity (95%) in testing. 4. Over 11,000 tests have influenced treatment decisions in 90% of cases. 5. Company focused on expanding market access and payer coverage for CNSide testing.
FAQ
Why Bullish?
PSTV's market opportunities increase with state licensing expansion for CNSide testing, similar to how Gilead saw growth after expanding product availability.
How important is it?
The expansion of testing services is crucial for revenue growth and market presence, which could significantly impact PSTV’s stock.
Why Long Term?
Long-term success depends on market access strategies and payer agreements, akin to the successful long-term growth seen in diagnostics companies like Exact Sciences.
Plus Therapeutics Expands CNSide Assay Platform to California
HOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV), has announced a significant expansion of its operations in the United States. The company has received lab licenses to administer its CNSide® Cerebrospinal Fluid (CSF) Tumor Cell Enumeration (TCE) laboratory-developed test (LDT) in California, Rhode Island, and Maryland. This development means CNSide Diagnostics is now authorized to provide its proprietary testing service in 48 out of 50 states.
Significance of State Licensure
Russ Bradley, President and General Manager of CNSide Diagnostics, stated, "Obtaining state licensure is a key enabler of our plan to bring the benefits of CNSide CSF testing to the broadest possible set of patients with CNS cancers." He emphasized the company's commitment to enhancing U.S. market access and launching strategies while anticipating continued expansion in coverage across payors and states.
Details of the CNSide® CSF Assay Platform
The CNSide® CSF Assay Platform facilitates rapid diagnoses, treatment monitoring, and guidance for patients with leptomeningeal metastases. The superior efficacy of CNSide® has been demonstrated in 9 peer-reviewed publications and the FORESEE clinical trial, as well as validated through real-world usage.
- Over 11,000 CNSide® tests conducted at more than 120 U.S. cancer institutions since 2020.
- High sensitivity of 92% and specificity of 95%.
- CNSide testing has influenced treatment decisions in 90% of cases.
The test is exclusively available through CNSide Diagnostics, LLC, which performs the evaluations in its CLIA certified facility located in Houston, Texas.
About CNSide Diagnostics and Plus Therapeutics
CNSide Diagnostics, LLC, a subsidiary of Plus Therapeutics, Inc., specializes in developing and commercializing proprietary laboratory-developed tests. Their flagship CNSide® product is designed to identify tumor cells that have metastasized to the central nervous system in patients suffering from carcinomas and melanomas. This platform permits quantitative analysis of cerebrospinal fluid, which enhances the management of patients with leptomeningeal metastases.
Plus Therapeutics, headquartered in Houston, Texas, is a clinical-stage pharmaceutical company focused on developing targeted radiotherapeutics to treat hard-to-manage CNS cancers. Utilizing image-guided local beta radiation along with targeted drug delivery, Plus Therapeutics is advancing a pipeline of products aimed at improving clinical outcomes in conditions such as leptomeningeal metastases (LM) and recurrent glioblastoma (GBM).
For further insights on CNSide Diagnostics, visit https://www.cnside-dx.com/. For comprehensive details about Plus Therapeutics, refer to their website at https://www.plustherapeutics.com.
Forward-Looking Statements
This press release includes forward-looking statements as per U.S. securities laws, particularly related to market expansion for CNSide and potential increased coverage of tests. Such statements involve inherent risks and uncertainties, including:
- Maintaining the listing of common stock on Nasdaq.
- Early-stage development of product candidates and therapies.
- Market performance and penetration challenges.
The company’s actual results could differ significantly from projections due to the risks mentioned above. Detailed discussions about risks are available in their filings with the SEC, including the annual report on Form 10-K for the fiscal year ending December 31, 2024, and other current reports. These documents can be accessed at www.sec.gov.
Investor Contact
For inquiries, please contact CORE IR at investor@plustherapeutics.com.