CNSide Diagnostics receives CMS accreditation for lab testing

HOUSTON - CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (NASDAQ:PSTV), has received a certificate of accreditation from the Centers for Medicare and Medicaid Services (CMS) for its laboratory in Houston, Texas, the company announced Thursday. According to InvestingPro data, Plus Therapeutics maintains a healthy balance sheet with more cash than debt, though the company faces profitability challenges with negative earnings over the last twelve months.

The accreditation confirms the lab’s compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, which are federal standards for laboratories performing tests on human specimens.

This certification represents a key regulatory milestone for the company’s CNSide cerebrospinal fluid (CSF) assay platform, which is designed to identify and analyze tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas.

"This is a key milestone on our trajectory to bring the CNSide cerebrospinal fluid assay platform to the broadest possible set of patients with or at risk for CNS cancers and simultaneously underscores our commitment to the highest quality standards," said Russ Bradley, CNSide Diagnostics President and General Manager, in the press release.

The certification is expected to help the company obtain state licensure in 48 of 50 states and secure reimbursement from both private insurers and government programs such as Medicare and Medicaid.

CNSide Diagnostics develops laboratory-developed tests designed to enable quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid.

Plus Therapeutics, the parent company, focuses on developing targeted radiotherapeutics for central nervous system cancers, with lead programs in leptomeningeal metastases and recurrent glioblastoma.

In other recent news, Plus Therapeutics has regained compliance with Nasdaq’s listing requirements, meeting both the Market Value of Listed Securities standard and the stockholders’ equity threshold. This compliance grants the company an extended deadline until November 12, 2025, to meet the $1.00 minimum bid price rule. Additionally, the company reported stockholders’ equity of $3 million as of June 30, 2025, surpassing the minimum requirement of $2.5 million. In a separate development, D. Boral Capital upgraded Plus Therapeutics’ stock rating from Hold to Buy, setting a price target of $5.00. This upgrade follows a previous downgrade by the same firm due to concerns about a potential reverse stock split. Furthermore, Plus Therapeutics announced positive results from a retrospective analysis of its CNSide Cerebrospinal Fluid Assay Platform, presented at a recent conference. The study showed that cerebrospinal fluid tumor cells were detected in 67% of patients, indicating the platform’s potential for monitoring leptomeningeal metastases. These developments reflect significant progress for the company in various aspects of its operations and market standing.

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