HOUSTON, Oct. 06, 2026 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), today announced the commercial launch of two new cerebrospinal fluid (CSF)-based molecular profiling tests, available to health care professionals in the United States beginning October 12, 2026:
- CNSide CSF Molecular Profile - Solid Tumor (DNA & RNA)
- CNSide CSF Molecular Profile - Hematologic Malignancies (DNA & RNA)
CNSide CSF Molecular Profile provides comprehensive DNA and RNA profiling of CNS disease biology from cerebrospinal fluid. The tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing, enabling broad characterization of genomic and transcriptomic alterations, including sequence variants, copy-number alterations, and gene fusions. The Hematologic Malignancies test also supports molecular assessment of clonality.
The launch significantly expands the patient population that can be served by CNSide. While CNSide® CSF Tumor Cell Enumeration (TCE) is focused on patients with suspected or confirmed leptomeningeal metastases, Molecular Profile extends CSF-based molecular testing to primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS.
"Physicians managing cancer in the CNS need more than confirmation that disease is present. They need information they can act on," said Russell Bradley, President and General Manager of CNSide Diagnostics, LLC. "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."
For patients with leptomeningeal metastases, Molecular Profile can be ordered independently or alongside TCE when both cellular and molecular assessment are clinically appropriate. TCE detects and quantitatively enumerates tumor cells, while Molecular Profile characterizes the DNA and RNA biology of disease, providing complementary cellular and molecular information from the same CSF collection.
The approach underlying CNSide CSF Molecular Profile was recently evaluated in a peer-reviewed, real-world study by Albitar et al., investigators at Genomic Testing Cooperative (GTC), published in The Journal of Liquid Biopsy1. The study analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS. Cancer-related molecular findings were identified in 78.4% of evaluable specimens. The study characterized multiple classes of molecular abnormalities, including sequence variants, copy-number and chromosomal alterations, gene fusions, and clonality.
CNSide CSF Molecular Profile is offered through CNSide Diagnostics' collaboration with GTC, announced in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis. CNSide Diagnostics manages test ordering, results delivery, physician support and billing.
The launch builds on CNSide's established experience in CSF-based oncology diagnostics. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions. The clinical utility of CNSide CSF tumor-cell analysis in leptomeningeal metastases has been evaluated in 12 peer-reviewed publications, prospective multicenter evidence from the FORESEE clinical study, and real-world clinical experience.
Ordering Information
Beginning October 12, 2026, health care professionals may order CNSide CSF Molecular Profile tests through CNSide Diagnostics. The tests may be ordered independently or, when appropriate, alongside CNSide CSF Tumor Cell Enumeration. Coverage and reimbursement vary by payer and patient benefit design.
CNSide CSF Tumor Cell Enumeration is a laboratory developed test performed by CNSide Diagnostics, LLC in its CLIA-certified, CAP-accredited laboratory in Houston, Texas. CNSide CSF Molecular Profile tests are laboratory developed tests currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA, a CLIA-certified and CAP-accredited reference laboratory. These tests have not been cleared or approved by the U.S. Food and Drug Administration and are available through CNSide Diagnostics to health care professionals in the U.S.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes cerebrospinal fluid-based diagnostic tests for cancers involving the central nervous system. The CNSide CSF diagnostics platform combines cellular analysis, biomarker characterization, and molecular profiling to support the detection, characterization, and longitudinal assessment of CNS malignancies.
Current offerings include CNSide CSF Tumor Cell Enumeration for patients with suspected or confirmed leptomeningeal metastases and CNSide CSF Molecular Profile tests for molecular characterization of primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS. For more information, visit www.cnside-dx.com.
About Cerenome
Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The Company's CNSide Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing.
Its lead therapeutic platform, REYOBIQ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation. By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.
Forward-Looking Statements
This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "potential," "anticipating," "planning" and similar expressions or the negatives thereof.
Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.
These statements include, without limitation, statements regarding the timing of availability of CNSide CSF Molecular Profile tests; its expected turnaround time, performance and clinical utility; physician adoption and ordering patterns; the timing and content of additional CNSide menu tests; coverage, billing and reimbursement for CNSide CSF Molecular Profile and other CNSide tests; the Company's reliance on third-party laboratory service providers; the potential market for CNSide tests; the timing in which CNSide tests are commercially launched and commercialization is expanded; the development and utility of CNSide tests; and expectations as to the Company's future performance, including the next steps in developing the Company's product candidates.
Actual results may differ materially due to a variety of risks and uncertainties, including those described in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statements, except as required by law.
¹ Albitar M, Charifa A, Agersborg S, et al. Using cell free DNA (cfDNA) and RNA (cfRNA) in the diagnosis and monitoring of primary and metastatic CNS tumors. The Journal of Liquid Biopsy. 2026;14:100500.
Investor Contact
CORE IR
IR@cerenome.com
