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Intended Use & Specifications

How is the CNSide® CSF TCE Test Used?

  • Tumor Types  - CNSide TCE assay is currently validated for suspected or confirmed LM of carcinoma origin (melanoma pending)

  • Limit of Detection (LoD) -  ~0.6 CSF-TCs/mL. The Lower Limit of Quantitation (LLOQ) is 13 CSF-TCs (5.2 tumor CSF-TCs/mL), and the Upper Limit of Quantitation is 1,905 tumor CSF-TCs (762 tumor CSF-TCs/mL)

  • Diagnostic Pathway  - CNSide can be utilized for both suspicion and monitoring of treatment response. Due to its quantitative nature, the assay can be used to determine the number of CSF-TCs in a patient that presents with suspicion of LM and then used as an adjunct to monitor changes in CSF-TC numbers, if any, on treatment

  • Testing Intervals  -  Per NCCN guidelines for Central Nervous System Tumors 2.2025 CSF Cytology should be evaluated every 4-8 weeks

  • Pediatric Use -  CNSide can be used in the setting of suspicion or confirmed LM. While rare, if a pediatric patient is suspicous for LM, then CNSide can be ordered.