Belay Diagnostics Validates Vantage™ Assay for CNS Cancer Detection and Prognosis
Belay Diagnostics Validates Vantage™ Assay
Belay Diagnostics, a laboratory accredited by CLIA and CAP, has announced the successful analytical validation of its Vantage™ assay, which is designed to detect MGMT (O6-methylguanine-DNA methyl-transferase) promoter methylation in cerebrospinal fluid (CSF). This critical advancement in molecular diagnostics is aimed at diagnosing both primary and metastatic cancers affecting the central nervous system (CNS). The findings were recently published in Cancer Genetics.
The Vantage™ assay employs quantitative polymerase chain reaction (qPCR) technology on DNA sourced from CSF samples, achieving a remarkable analytical sensitivity of 95.5% and a specificity rate of 100%. This accuracy is vital, as MGMT promoter methylation status is an important indicator in the prognosis of gliomas, particularly glioblastoma, which can be severely aggressive with a median survival time of only six months for patients.
MGMT is recognized as one of the most significant prognostic biomarkers in glioblastoma, with positive methylation status correlating to better responses to alkylating agents like Temozolomide. The new Vantage™ assay stands out by offering a minimally invasive method of assessing methylation status. Traditional methods require invasive biopsies that depend on acquiring larger samples of CNS tissue, making this new assay a preferred option due to the necessity of only 5 ng of DNA.
The Vantage™ assay can assess methylation using a mere 2–3 ml of CSF, offering a clear advantage by significantly reducing the volume of fluid needed compared to standard cytology and flow cytometry practices. This not only simplifies the implementation of the assay into current clinical workflows but also enhances the comfort and safety of the patient during sample collection.
Another breakthrough in this assay is its unique enzymatic conversion method, which preserves the integrity of DNA and reduces the likelihood of damage that often occurs with traditional bisulfite conversion methods. This process aims to enhance the quality of the resulting DNA, ultimately improving the accuracy of subsequent analyses.
The validation study indicated that by utilizing this innovative approach, the Vantage™ assay can yield results swiftly, with a turnaround time of just three days. When paired with Summit™, another diagnostic tool developed by Belay for genomic profiling in CNS cancers, the total turnaround time is extended to 7–10 days, facilitating a more dynamic patient care process.
CEO Brian Coe expressed gratitude for the collaborative efforts behind developing the Vantage™ assay, acknowledging the hard work of the team at Belay as well as their partners at Johns Hopkins University. “We are thrilled to bring such pioneering testing methods to clinicians,” he stated, emphasizing the importance of innovative solutions in treating brain cancer.
About Belay Diagnostics
Belay Diagnostics is dedicated to revolutionizing diagnostic technologies for CNS cancers. The company offers advanced liquid biopsy tests, such as Vantage™ and Summit™, that provide molecular insights crucial to enhancing diagnostic precision, tumor classification, and overall treatment planning. Belay's mission is to optimize patient pathways, ensuring that those impacted by CNS tumors receive the most effective and timely care possible.
By delivering these advanced tests to medical professionals, Belay aims to bridge the gap in the diagnostic process, making significant strides for patients and their families in navigating through cancer challenges.