Belay Diagnostics Receives NIH Award to Advance Multi-Omic CSF Assay for Brain Cancer Diagnosis

Belay Diagnostics has been awarded funding from the National Institutes of Health (NIH) to support the development of a multi-omic cerebrospinal fluid (CSF) assay designed to detect primary brain cancers without surgical biopsy.

The project addresses a significant gap in neuro-oncology. Brain imaging identifies incidental abnormalities in up to 25% of MRI scans, and distinguishing a malignant tumor from a benign condition currently requires invasive tissue biopsy. No clinically available biomarkers in exist for CNS malignancies, in part because brain tumors rarely shed detectable DNA into the bloodstream the way other cancers do.

Belay’s approach targets cerebrospinal fluid instead, where provocative early data suggests that malignant gliomas shed tumor-derived DNA into the CSF. The funded research will establish pre-analytic quality control procedures, determine analytical sensitivity and specificity, and assess clinical validity, with the goal of commercializing a CLIA-certified molecular diagnostic for primary brain cancers.

For the thousands of patients each year facing diagnostic uncertainty after an abnormal brain scan, a reliable CSF-based test could mean earlier answers, faster specialist referrals, and in many cases, the relief of ruling out cancer without surgery.