Belay Diagnostics Announces the Validation of Summit™ 2.0 Comprehensive Genomic Profile Assay in Cerebrospinal Fluid (CSF)

Validation Data on 118 Patients Published in Cancers

CHICAGO, Feb. 18, 2026 /PRNewswire/ -- Belay Diagnostics, an innovative CLIA/CAP accredited laboratory focused on the development and commercialization of molecular diagnostics targeting central nervous system (CNS) cancers, announced the results from the analytical and clinical validation of its Belay Summit™ 2.0 Comprehensive Genomic Profile assay. The study used both tissue biopsy-matched and definitively diagnosed cerebrospinal fluid (CSF) samples from patients with primary and metastatic CNS cancers, as detailed in the peer-reviewed journal Cancers. This makes the Belay Summit™ 2.0 assay the only CSF liquid biopsy test with complete clinical validation against specimens that are tissue-matched or have a definitive diagnosis.

https://doi.org/10.3390/cancers18020256

Summit™ 2.0 is a CSF-based liquid biopsy assay designed to enable comprehensive genomic profiling for characterization of CNS tumors. CNS malignancies present unique diagnostic challenges, as tissue-based testing is frequently infeasible, and the blood–brain barrier restricts the utility of plasma-based liquid biopsy as an effective alternative. The assay evaluates tumor-derived total nucleic acid extracted from CSF, enabling detection of multiple clinically relevant biomarkers, including single nucleotide variants (SNVs), insertions/deletions (Indels), copy number variants (CNVs), fusions, and immunotherapy-associated biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI).

The analytical validation study demonstrated robust and reproducible detection of all supported variant classes using as little as 15 ng of tumor-derived nucleic acid from CSF, with an analytical sensitivity of 96.7% for SNVs and Indels with a 100% limit of detection at a variant allele frequency of 0.3%. Clinical validation across 118 CSF specimens demonstrated a clinical sensitivity of 96% and a specificity of 98% for the detection of CNS malignancies.

This clinical validation represents the only CSF liquid biopsy validated using tissue-matched or definitively diagnosed samples to date.

In this study, the clinical cohort included a broad range of primary and metastatic CNS tumors, including gliomas, astrocytomas, glioblastomas, medulloblastomas, lymphomas, and metastatic cancers originating from lung, breast, melanoma, and other solid tumors. The expanded content of Summit™ 2.0 further demonstrated improved detection yield compared to its prior generation assay, identifying clinically significant alterations in cases previously characterized as negative using Summit™ 1.0.

"We're proud to make advanced testing like Summit™ 2.0 available to clinicians caring for patients with CNS cancers," said Brian Coe, Co-founder and Chief Executive Officer of Belay Diagnostics. "This work reflects the dedication of our team at Belay and our collaborators at Johns Hopkins University to delivering minimally invasive diagnostic tools that can meaningfully support patient care."

About Belay Diagnostics

Belay Diagnostics is focused on pioneering diagnostic technologies that transform the CNS cancer journey. Belay's Summit™, Ascent™, and Vantage™ advanced liquid biopsy tests in CSF provide molecular characterization that can enhance diagnostic accuracy, tumor classification, prognostic insight, therapeutic actionability, and clinical trial options for patients with CNS tumors and malignancies. Our mission is to serve patients and those who care for them. Together, we can help patients with CNS tumors find a path forward.

Belay Diagnostics | Brain & Spinal Cord Cancer Testing

SOURCE Belay Diagnostics