Curated News
By: NewsRamp Editorial Staff
September 18, 2025
CNSide Diagnostics Achieves CMS Accreditation for Cancer Testing Lab
TLDR
- CNSide Diagnostics gains CMS accreditation, enabling broader insurance reimbursement and market access for its CNS cancer testing platform.
- CMS accreditation certifies CNSide Diagnostics' Houston lab meets CLIA standards for proficiency testing, personnel qualifications, and quality control procedures.
- This accreditation expands access to CNSide's advanced cancer diagnostics, improving early detection and management of central nervous system cancers for patients.
- CNSide's CSF assay platform can detect tumor cells in spinal fluid using quantitative analysis and molecular characterization techniques.
Impact - Why it Matters
This accreditation matters because it directly impacts patient access to advanced cancer diagnostics. CMS certification enables broader insurance coverage, including Medicare and Medicaid, making the CNSide testing platform more accessible to patients nationwide. For individuals facing central nervous system cancers, this means potentially earlier detection and better management of leptomeningeal metastases through sophisticated CSF analysis. The certification also validates the laboratory's quality standards, giving healthcare providers and patients confidence in the test results. As CNS cancers often present complex diagnostic challenges, this advancement represents progress in personalized cancer care and could lead to improved treatment outcomes for patients with these difficult-to-treat conditions.
Summary
CNSide Diagnostics, a wholly-owned subsidiary of clinical-stage pharmaceutical company Plus Therapeutics, has achieved a significant regulatory milestone by receiving a certificate of accreditation from the Centers for Medicare & Medicaid Services (CMS) for its Houston-based laboratory. This certification confirms compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations, which are federal standards governing laboratories that perform testing on human specimens. The accreditation represents a crucial step in the company's strategy to bring its innovative CNSide cerebrospinal fluid (CSF) assay platform to patients with or at risk for central nervous system cancers while demonstrating their commitment to the highest quality standards.
Russ Bradley, CNSide Diagnostics President and General Manager, emphasized that this achievement is "a key milestone on our trajectory to bring the CNSide CSF assay platform to the broadest possible set of patients" and underscores the company's dedication to quality. The certification ensures that the laboratory meets all requirements for proficiency testing, personnel qualifications, and quality control. This accreditation is essential for achieving several additional milestones, including obtaining state licensure in 48 states, securing broad-based commercial insurance coverage, accessing government payor coverage through Medicare and Medicaid programs, and expanding payment coding for unique reimbursement billing codes.
The CNSide Diagnostics platform specializes in developing proprietary laboratory-developed tests, particularly the CNSide® CSF Assay Platform, which enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid. This technology is designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas, ultimately improving the management of patients with leptomeningeal metastases. Plus Therapeutics, the parent company, focuses on developing targeted radiotherapeutics for difficult-to-treat CNS cancers, with lead programs in leptomeningeal metastases and recurrent glioblastoma.
Source Statement
This curated news summary relied on content disributed by citybiz. Read the original source here, CNSide Diagnostics Achieves CMS Accreditation for Cancer Testing Lab
