Plus Therapeutics Subsidiary CNSide Diagnostics Achieves CLIA 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 for its clinical laboratory located in Houston, Texas. The accreditation confirms compliance with Clinical Laboratory Improvement Amendments regulations, which represent federal standards for laboratories performing testing on human specimens.

This accreditation represents a critical milestone for bringing the CNSide cerebrospinal fluid assay platform to patients with or at risk for central nervous system cancers while demonstrating commitment to the highest quality standards. Russ Bradley, CNSide Diagnostics President and General Manager, stated that this achievement marks the latest tangible accomplishment in the company's U.S. market access and launch strategy.

The certification ensures laboratories meet all requirements for proficiency testing, personnel qualifications, and quality control. This milestone is necessary for achieving several additional objectives including obtaining state licensure in 48 of 50 states, ensuring broad-based commercial insurance coverage, accessing government payor coverage through Medicare and Medicaid programs, and expanding payment coding through pursuit of unique reimbursement billing codes.

Lab accreditation is mandatory for laboratories to enroll in Medicare and Medicaid programs and receive payments for testing services, making this achievement essential for broader patient access. The CNSide CSF Assay Platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid, which informs and improves management of patients with leptomeningeal metastases. For more information about the company's developments, visit https://www.plustherapeutics.com.