CNSide Diagnostics Receives CMS Accreditation for Houston Laboratory, Expanding Access to CNS Cancer Testing

CNSide Diagnostics, a wholly-owned subsidiary of Plus Therapeutics, has received certificate of accreditation from the Centers for Medicare & Medicaid Services for its clinical laboratory in Houston, Texas. This accreditation confirms compliance with Clinical Laboratory Improvement Amendments regulations, which establish federal standards for laboratories conducting testing on human specimens.

Russ Bradley, CNSide Diagnostics President and General Manager, stated that this achievement represents a key milestone in bringing the CNSide cerebrospinal fluid assay platform to the broadest possible set of patients with or at risk for CNS cancers while demonstrating commitment to the highest quality standards. The certification ensures laboratories meet all requirements for proficiency testing, personnel qualifications, and quality control measures.

The accreditation enables several critical operational advancements, including obtaining state licensure in 48 of 50 states, securing reimbursement from private payors through broad-based commercial insurance coverage, and accessing government payor coverage through Medicare and Medicaid programs. Additionally, lab accreditation serves as a necessary step for pursuing and registering unique reimbursement billing codes that facilitate patient access to testing services.

CNSide Diagnostics develops and commercializes proprietary laboratory-developed tests, including the CNSide platform, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The technology enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid, providing critical information for managing patients with leptomeningeal metastases.

This accreditation represents the latest tangible accomplishment in the company's U.S. market access and launch strategy, positioning the laboratory to serve a wider patient population while maintaining compliance with federal quality standards. The achievement supports broader commercialization efforts and enhances the laboratory's ability to provide diagnostic services that inform treatment decisions for patients with challenging CNS cancers.