Belay Diagnostics Announces US Commercial Launch of Summit™: Breakthrough CSF Testing for CNS Cancer Detection and Management

Validation Data on More Than 100 Patients published in Journal of Molecular Diagnostics

CHICAGO, April 25, 2025 /PRNewswire/ -- Belay Diagnostics, a CLIA/CAP accredited laboratory focused on the development and commercialization of molecular diagnostics targeting central nervous system (CNS) cancers, announced today the results of the analytical validation and clinical sensitivity study of the Belay Summit™ assay for detection of DNA variants in cerebrospinal fluid (CSF) of primary and metastatic CNS cancers as reported in The Journal of Molecular Diagnostics  https://www.sciencedirect.com/science/article/pii/S1525157825000923

Summit is a CSF liquid biopsy test that sequences nucleic acid from a patient's tumor to aid oncologists in making more informed, personalized treatment decisions. Summit harnesses MethylSaferSeqS, a proprietary duplex sequencing method that captures trace fragments of tumor DNA shed into the CSF ("tumor derived DNA"). This provides high-accuracy tumor sequencing information at the single-gene level and hot spot regions while requiring low input DNA (≥20ng tumor DNA).

The Summit clinical validation encompassed 124 patients with primary and secondary CNS cancers across both common and rare phenotypes. Glioblastomas, gliomas, medulloblastomas, and astrocytomas were included for primary CNS cancers. For metastatic CNS cancers, cancers originating in the lung, breast, and diffuse large B-cell lymphomas were included. The concordance of tumor derived DNA from CSF with biopsy-derived alterations or definitive diagnosis was found to achieve 90% sensitivity and 95% specificity.

"I am grateful to have the opportunity to serve patients with our Summit assay and am deeply appreciative of our team members at Belay and Johns Hopkins University who work so diligently to bring this testing to market" said Brian Coe, Co-founder and Chief Executive Officer of Belay Diagnostics.

About Belay Diagnostics
Belay Diagnostics is focused on pioneering diagnostic technologies that transform the CNS cancer journey. Belay's Summit™ and Vantage™ advanced liquid biopsy tests in CSF inform diagnosis, therapeutic actionability and clinical trial options for those 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

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SOURCE Belay Diagnostics