Belay Diagnostics Announces the Validation of Vantage™ Assay for Evaluation of MGMT Promoter Methylation in Cerebrospinal Fluid

Validation Data on 60 Patients published in Cancer Genetics

CHICAGO, July 7, 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 the results of the analytical validation study of the Belay Vantage^™ assay for detection of MGMT (Methylation of the O6-methylguanine-DNA methyl-transferase) promoter methylation in cerebrospinal fluid (CSF) for primary and metastatic CNS cancers as reported in Cancer Genetics. The assay uses quantitative polymerase chain reaction (qPCR) on DNA extracted from CSF and has an analytical sensitivity of 95.5% and specificity of 100%.
https://doi.org/10.1016/j.cancergen.2025.04.001.

MGMT promoter methylation testing is recommended in all high-grade gliomas. MGMT is one of the strongest prognostic and predictive biomarkers in glioblastoma, an aggressive cancer with a prognosis of six months or less that accounts for nearly 50% of all primary brain malignancies. Positive MGMT status is associated with a more favorable response to alkylating chemotherapies such as Temozolomide (TMZ).

The Belay Vantage^™ assay evaluates MGMT promoter methylation status through innovative and minimally invasive sampling of CSF for individuals with known or suspected CNS tumors using low input DNA (5 ng). This represents a distinct advantage over the current method of MGMT testing where invasive biopsy or resection is used to obtain patient samples and 40–250 ng of vital CNS tissue is required. Importantly, the study demonstrates the use of just 2–3 ml of CSF, significantly less than that used by standard of care cytology and flow cytometry, enabling easy implementation into existing clinical workflows. Vantage is the first to use an enzymatic conversion method that maintains integrity of the patient's DNA and minimizes degradation, thereby increasing ability to process DNA downstream, improving accuracy. In contrast, currently available commercial tests use bisulfite conversion that cause DNA damage. The novelty of performing this assay directly from CSF versus tissue facilitates a rapid 3-day turnaround. When ordered with Summit^™, Belay's pioneering CSF-based tumor-derived genomic profiling assay for patients with CNS cancer, the turnaround is 7–10-days.

"We are grateful to have the opportunity to bring novel and essential testing such as Vantage and Summit to clinicians in order to serve patients with these conditions. I am appreciative of our team members at Belay and Johns Hopkins University who work diligently in providing innovative solutions to inform diagnosis and management of brain cancer," 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 provide molecular characterization that can markedly enhance diagnostic accuracy, tumor classification, predictive prognosis, 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

SOURCE Belay Diagnostics