Plus Therapeutics Subsidiary CNSide Diagnostics Receives CMS Accreditation for CNS Cancer Testing Laboratory

CNSide Diagnostics, a wholly-owned subsidiary of Plus Therapeutics, has received certificate of accreditation from the Centers for Medicare & Medicaid Services (CMS) for its clinical laboratory in Houston, Texas. The accreditation confirms compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, which represent 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 making the CNSide cerebrospinal fluid assay platform available to the broadest possible set of patients with or at risk for central nervous system cancers. The certification demonstrates the company's commitment to maintaining the highest quality standards while advancing its U.S. market access and launch strategy.

The CMS accreditation ensures that laboratories meet all requirements for proficiency testing, personnel qualifications, and quality control measures. This certification serves as a necessary foundation for achieving several critical operational milestones, including obtaining state licensure in 48 of 50 states, securing broad-based commercial insurance coverage for patient testing, accessing government payor coverage through Medicare and Medicaid programs, and expanding payment coding through pursuit of unique reimbursement billing codes.

CNSide Diagnostics develops and commercializes proprietary laboratory-developed tests, including the CNSide platform, which is 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 cerebrospinal fluid, providing critical information that improves management of patients with leptomeningeal metastases. For additional information about the parent company's developments, visit https://www.plustherapeutics.com.

The accreditation represents a significant step forward in diagnostic capabilities for central nervous system cancers, potentially improving early detection and treatment monitoring for patients facing these challenging conditions. This development may influence clinical practice patterns and insurance coverage policies for cerebrospinal fluid-based cancer diagnostics across the healthcare industry.