Plus Therapeutics Announces National Coverage Agreement with UnitedHealthcare Insurance Company for CNSide® Cerebrospinal Fluid Assay for Metastatic CNS Cancer
Rhea-AI Summary
Plus Therapeutics (Nasdaq: PSTV) has secured a significant national coverage agreement with UnitedHealthcare Insurance Company for its CNSide® Cerebrospinal Fluid Tumor Cell Enumeration test. The agreement, effective September 15, 2025, extends coverage to over 51 million people across the United States.
The CNSide® CSF Assay Platform, which has demonstrated 92% sensitivity and 95% specificity, aids in diagnosing and monitoring patients with leptomeningeal metastases. The test has been validated through 9 peer-reviewed publications and the FORESEE clinical trial, with over 11,000 tests performed at more than 120 U.S. cancer institutions since 2020, influencing treatment decisions in 90% of cases.
Positive
- Secured national coverage agreement with UnitedHealthcare, reaching over 51 million people
- High clinical efficacy with 92% sensitivity and 95% specificity rates
- Strong market validation with 11,000+ tests performed across 120+ U.S. cancer institutions
- Test influences treatment decisions in 90% of cases
- Backed by 9 peer-reviewed publications and clinical trial data
Negative
- None.
News Market Reaction
On the day this news was published, PSTV gained 39.29%, reflecting a significant positive market reaction. Argus tracked a peak move of +59.5% during that session. Our momentum scanner triggered 39 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $21M to the company's valuation, bringing the market cap to $73M at that time. Trading volume was exceptionally heavy at 54.5x the daily average, suggesting very strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
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 diagnoses, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. The superior clinical utility of CNSide® over standard of care has been shown in 9 peer-reviewed publications, the FORESEE clinical trial, and has been validated in the market through real-world use.
More than 11,000 CNSide® tests have been performed at over 120 U.S. cancer institutions since 2020, delivering high sensitivity (
This test is available exclusively through CNSide Diagnostics, LLC. as a testing service provided to health care professionals in the U.S.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in the cerebrospinal fluid that inform and improve the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/.
About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com.
About UnitedHealthcare Group
UnitedHealth Group (NYSE: UNH) is a health care and well-being company with a mission to help people live healthier lives and help make the health system work better for everyone through two distinct and complementary businesses. Optum delivers care aided by technology and data, empowering people, partners and providers with the guidance and tools they need to achieve better health. UnitedHealthcare offers a full range of health benefits, enabling affordable coverage, simplifying the health care experience and delivering access to high-quality care. Visit UnitedHealth Group at www.unitedhealthgroup.com
Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect,” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the potential market for the CNSide CSF Assay, the timing in which the CNSide CSF Assay is commercially launched and commercialization is expanded, revenue and corporate profitability expectations including support reimbursements and payments for the CNSide CSF Assay, the development and utility of the CNSide CSF Assay and expectations as to the Company’s future performance, including the next steps in developing the Company’s product candidates.
Investor Contact
CORE IR
investor@plustherapeutics.com
FAQ
What is the coverage agreement between Plus Therapeutics (PSTV) and UnitedHealthcare?
How effective is the CNSide® test for metastatic CNS cancer?
How many CNSide® tests has Plus Therapeutics performed since 2020?
What clinical validation supports Plus Therapeutics' CNSide® test?
When does the UnitedHealthcare coverage for PSTV's CNSide® test begin?
