# Multi-omic CSF Assay for the Diagnosis of Brain Cancers

> **NIH NIH R42** · BELAY DIAGNOSTICS, LLC · 2024 · $303,845

## Abstract

PROJECT SUMMARY
Brain imaging with computed tomography (CT) or magnetic resonance imaging (MRI) is becoming increasingly
used in clinical practice. In up to 25% of MRI scans, an incidental brain abnormality is identified. The list of
potential etiologies for these findings is vast and can include benign conditions such as inflammatory or
developmental processes or could also include neoplastic entities such as malignant gliomas. Approximately
17,000 individuals each year are diagnosed with a malignant glioma in the United States and the nearly of
these patients will succumb to their disease. Therefore, the need to reliably and quickly distinguish a neoplastic
from a non-neoplastic condition is of significant importance. Unfortunately, currently there are no clinically
available biomarkers for CNS malignancies. Correctly identifying these abnormalities as non-malignant is
important because such patients rarely benefit from surgical biopsy and can almost always be managed non-
operatively. And a diagnosis other than CNS malignancy can alleviate much of the anxiety experienced by
patients without cancer after imaging. In contrast, patients with cancer could benefit from correct diagnosis by
spurring immediate consultation with appropriate neurosurgical and oncology specialists. As a result, there is
an pressing and urgent need for more sensitive and specific tumor biomarkers in neuro-oncology.
We and others have shown that most cancers shed cell free molecules of tumor derived DNA into the
circulation and that these molecules can be quantified as a measure of disease burden. Brain tumors are the
exception to the rule and rarely shed detectable levels DNA into the bloodstream. However, we have
provocative data to suggest that malignant gliomas shed cell free molecules of tumor derived DNA into the
cerebrospinal fluid (CSF-tDNA). We have developed a robust multi-omic technology, CSF-TumorDx, that can
sensitively and specifically detect trace quantities of CSF-tDNA from 1-2 ml of CSF. In this Fast-Track
application we will i) establish pre-analytic quality control procedures, ii) determine the analytical sensitivity and
specificity of CSF-TumorDx and iii) determine the clinical validity of CSF-TumorDx.
At the completion of this grant, Belay Diagnostics will be poised to commercialize the first multi-omic molecular
diagnostic for primary brain cancers in a CLIA setting. This could have an immediate impact on the thousands
of individuals facing diagnostic uncertainty from a brain lesion identified on imaging.

## Key facts

- **NIH application ID:** 10823579
- **Project number:** 1R42NS135834-01
- **Recipient organization:** BELAY DIAGNOSTICS, LLC
- **Principal Investigator:** CHETAN BETTEGOWDA
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $303,845
- **Award type:** 1
- **Project period:** 2024-07-01 → 2024-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10823579

## Citation

> US National Institutes of Health, RePORTER application 10823579, Multi-omic CSF Assay for the Diagnosis of Brain Cancers (1R42NS135834-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10823579. Licensed CC0.

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