Belay Diagnostics Validates New MGMT Test for Brain Cancer Detection

Belay Diagnostics Evaluation Received the Green Signal

Image Credits: Nature

Announcement

Belay Diagnostics, a CAP/CLIA Laboratory known for its commercialization and development of molecular diagnostics, mainly focusing on central nervous system (CNS) cancers, has confirmed the analytical validation for the study of Belay Vantage™. It’s an assay for detecting MGMT (Methylation of the O6-methylguanine-DNA methyl-transferase), which is a promoter methylation in cerebrospinal fluid (CSF) for metastatic CNS cancers as per the cancer genetics. The assay uses several polymerase chain reactions (qPCR) on DNA extracted from CSF and is 95.5% sensitive and rates 100% specificity.

Importance of MGMT

MGMT promoter methylation testing is recommended for high-grade gliomas. MGMT is a predictive biomarker and a strong prognostic factor in glioblastoma. It is a severe cancer with a prognosis of less than six months, or six months with 50% of primary brain malignancies. The MGMT’s positive status is linked to its favorable response towards alkylating chemotherapies like Temozolomide (TMZ).

The Evaluation

The Belay Vantage™ assay evaluated MGMT potential via innovation and implementation of less sampling of CSF for a group with CNS tumors, applying low-input DNA (5 NG). This demonstrates an advantage in its current method for MGMT testing in which resection is applicable to procure patients' samples along with 40-250 ng of vital CNS tissue, as per the requirement. The study elaborates the use of 2-3 ml of CSF, which is less than the standard flow cytometry and cytology. This provides a disruptive execution in its existing clinical workflows. Vantage has been a primary head to the conversion method that reduces degradation and integrates patients’ DNA. It also stimulates the process of DNA downstream. The current commercial test uses bisulfite conversion, which is harmful to DNA. Belay’s assay for CNS cancer patients will take 7-10 days of turnaround time.

This evaluation and idea is a validated solution that has covered precision and effectiveness. Further, the study will strengthen the portfolio of the laboratory and introduce an innovation in the healthcare market.

Views and Statements

Co-Founder and Chief Executive Officer of Belay Diagnostics, Brian Coe, said, “We are excited and grateful for this opportunity to introduce valuable testing like Summit and Vantage to clinicians for providing the best to the patients with similar or related conditions. I appreciate the team members of our company at Johns Hopkins and Belay, who worked sincerely for developing and introducing innovative solutions to address management and diagnosis of brain cancer.”