The DNA and RNA sequencing panels analyze cell-free DNA and more than 1,600 transcripts to evaluate primary, metastatic, and hematologic malignancies.
CNSide Diagnostics, a subsidiary of Cerenome, has commercially launched two new cerebrospinal fluid (CSF)-based molecular profiling tests for central nervous system (CNS) oncology. Available to health care professionals in the US beginning Oct 12, the panels include CNSide CSF Molecular Profile – Solid Tumor (DNA & RNA) and CNSide CSF Molecular Profile – Hematologic Malignancies (DNA & RNA).
The launch expands the platform beyond leptomeningeal metastases to include primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS. While the existing CNSide CSF Tumor Cell Enumeration (TCE) test focuses on detecting and quantitatively enumerating tumor cells in patients with suspected or confirmed leptomeningeal metastases, the new molecular profiles characterize the underlying DNA and RNA biology of disease.
“Physicians managing cancer in the CNS need more than confirmation that disease is present. They need information they can act on,” says Russell Bradley, president and general manager of CNSide Diagnostics, LLC, in a release. “Molecular Profile adds DNA and RNA findings, including potentially actionable alterations, to the cellular information CNSide already provides, and extends CNSide beyond leptomeningeal metastases to primary CNS tumors and hematologic cancers involving the CNS.”
Multi-Omic Profiling Capabilities
The molecular profiling assays evaluate more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts using RNA sequencing. This testing structure permits characterization of multiple genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. In addition, the hematologic malignancies test supports the molecular assessment of clonality.
For patients evaluated for leptomeningeal metastases, clinicians can order the molecular profile independently or in tandem with tumor cell enumeration using the same CSF collection.
Clinical Evidence and Laboratory Operations
The methodology supporting the profile was evaluated in a real-world study conducted by investigators at Genomic Testing Cooperative (GTC) and published in The Journal of Liquid Biopsy. In an analysis of 1,391 evaluable CSF specimens from patients evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS, cancer-related molecular findings were identified in 78.4% of specimens. The study captured several molecular abnormality types, such as sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality.
The molecular profile is offered through an agreement established between CNSide Diagnostics and GTC in July 2026. GTC performs the DNA and RNA sequencing as well as bioinformatics analysis, while CNSide Diagnostics oversees test ordering, results delivery, physician support, and billing.
Both molecular profile panels are laboratory developed tests performed by GTC, LCA, a CLIA-certified and CAP-accredited reference laboratory. The tests have not been cleared or approved by the US Food and Drug Administration. Meanwhile, the tumor cell enumeration test remains an LDT processed by CNSide Diagnostics in its CLIA-certified, CAP-accredited facility in Houston, Texas. Since 2020, more than 11,000 CNSide tests have been performed across more than 120 US cancer institutions.
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