Belay Diagnostics

Belay Diagnostics is transforming how brain and spinal cord cancers are diagnosed and managed through advanced cerebrospinal fluid (CSF) liquid biopsy testing. Founded by a team of neurosurgeons, scientists, and entrepreneurs, the company has developed proprietary molecular testing technology that analyzes tumor-derived nucleic acids found in CSF to provide clinicians with critical genomic insights without the risks associated with invasive tissue biopsies.

The company offers a growing portfolio of three FDA-cleared CSF liquid biopsy tests: Summit™ 2.0, Ascent™, and Vantage™. Summit™ 2.0 is a comprehensive genomic profiling assay that evaluates 520 genes for SNVs, MNVs, indels, copy number variations, fusions, tumor mutational burden (TMB), and microsatellite instability (MSI). The platform demonstrates exceptional clinical performance with 96% sensitivity and 98% specificity across metastatic cancers and primary CNS malignancies including glioblastoma, oligodendroglioma, and medulloblastoma.

Belay Diagnostics emerged from research conducted at Johns Hopkins University, one of the world's premier oncology institutions. The company's innovative approach addresses significant limitations in traditional diagnostic methods such as cytology and MRI, which often lack sensitivity, while tissue biopsies carry substantial patient risk. By providing a minimally invasive alternative that delivers comprehensive molecular characterization, Belay enables faster, more informed clinical decision-making for patients facing suspected central nervous system malignancies.

Headquartered in Chicago, Illinois, Belay Diagnostics is actively expanding commercial operations and has received recognition from the National Comprehensive Cancer Network (NCCN), which updated its guidelines to recommend CSF-based genomic profiling for biopsy-infeasible high-grade gliomas. The company has also received NIH funding to advance its multi-omic CSF assay technology.