#USA #Chicago #Belay Diagnostics #CNS Cancer #Summit Test

Belay Diagnostics Unveils Groundbreaking Summit™ Test for CNS Cancer Detection

Belay Diagnostics, a leading laboratory accredited by CLIA and CAP, has announced the commercial launch of its innovative Summit™ test aimed at revolutionizing the diagnosis and management of central nervous system (CNS) cancers. This groundbreaking liquid biopsy test identifies critical DNA variants in the cerebrospinal fluid (CSF) of patients, providing medical professionals with vital information to tailor treatment plans effectively.

The company recently published validation data based on a study involving 124 patients diagnosed with CNS cancers in the Journal of Molecular Diagnostics. These results indicate that the Summit™ assay exhibits significant analytical validation and clinical sensitivity, thereby offering a reliable tool for oncologists to enhance their decision-making processes.

The Summit™ test employs a unique methodology known as MethylSaferSeqS, which efficiently captures and sequences minimal traces of DNA shed from tumors into the CSF. This process allows for high-accuracy sequencing at the individual gene level, while only requiring a small amount of input DNA (approximately 20ng). Such low requirements make it possible to analyze samples from a broader range of patients, including those where traditional biopsies may be difficult or risky.

The clinical validation of the Summit™ assay included both common and rare CNS tumors, such as glioblastomas, gliomas, medulloblastomas, and astrocytomas for primary cancers, as well as metastatic cancers that originate in the lung, breast, and certain types of lymphomas. Notably, the test demonstrated an impressive sensitivity of 90% and specificity of 95% when comparing tumor-derived DNA from CSF against biopsy-derived alterations or definitive diagnoses.

Brian Coe, CEO and co-founder of Belay Diagnostics, expressed deep gratitude for the collaborative effort between the Belay team and Johns Hopkins University, stating, "I am grateful to have the opportunity to serve patients with our Summit assay and appreciate our team members who diligently worked to bring this testing to market."

The Summit™ test is part of Belay's broader commitment to pioneering diagnostic technologies that significantly improve the journey for patients diagnosed with CNS cancers. Alongside its Vantage™ advanced liquid biopsy test, Belay is dedicated to providing enhanced diagnostic clarity, therapeutic suggestions, and clinical trial opportunities for individuals facing these challenging malignancies.

With the introduction of the Summit™ test, Belay Diagnostics aims to empower patients and their healthcare providers with essential insights to navigate the complexities of CNS cancer treatment and management. As they set out to transform the landscape of CNS cancer diagnostics, the company remains focused on advancing patient outcomes through cutting-edge research and innovative technology.

In conclusion, Belay Diagnostics' launch of the Summit™ test is a promising advancement in the fight against CNS cancers. It not only represents a technical achievement in the realm of liquid biopsies but also signifies a major step forward in personalized medicine, ensuring that each patient receives the tailored treatment they deserve for better management and recovery of CNS tumors.