The laboratory-developed test is used to detect and monitor metastatic central nervous system cancer.
UnitedHealthcare Insurance Company has signed a national coverage agreement for the CNSide cerebrospinal fluid assay, a laboratory-developed test used to detect and monitor metastatic central nervous system cancer, announced CNSide Diagnostics.
The agreement, effective Sept 15, covers more than 51 million people throughout the US for the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test. CNSide Diagnostics LLC, a wholly-owned subsidiary of Plus Therapeutics Inc, developed and commercializes the assay exclusively as a testing service to US healthcare professionals.
The CNSide CSF Assay Platform supports diagnosis, treatment monitoring, and treatment guidance for patients with leptomeningeal metastases. The test demonstrates 92% sensitivity and 95% specificity while influencing treatment decisions in 90% of cases, according to the company.
More than 11,000 CNSide tests have been performed at over 120 US cancer institutions since 2020. The test’s clinical utility has been documented in nine peer-reviewed publications and validated through the FORESEE clinical trial and real-world use.
Laboratory-Developed Test for CNS Metastases
The CNSide platform enables quantitative analysis and molecular characterization of tumor cells and circulating tumor DNA in cerebrospinal fluid. The test is designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas.
Leptomeningeal metastases occur when cancer cells spread to the thin layers of tissue covering the brain and spinal cord. This condition affects patients with various cancer types and can be challenging to diagnose using standard methods.
“The superior clinical utility of CNSide over standard of care has been shown in nine peer-reviewed publications, the FORESEE clinical trial, and has been validated in the market through real-world use,” the company stated in its announcement.
Plus Therapeutics, headquartered in Houston, Texas, is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system. The company’s pipeline includes programs in leptomeningeal metastases and recurrent glioblastoma.
CNSide Diagnostics operates as the diagnostic subsidiary, focusing on laboratory-developed tests for central nervous system cancer detection and monitoring.
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