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Belay Diagnostics Reports 82% Clinical Impact Rate for Summit™ and Vantage™ in CNS Lymphoma Study

In a groundbreaking new retrospective study, Belay Diagnostics announced that its innovative tests, Summit and Vantage, have demonstrated a remarkable 82% clinical impact rate in cases of Central Nervous System (CNS) lymphoma. Conducted on 50 specimens from 48 patients during the first year of the tests' commercial availability, the study showcases the potential of these tests to address critical needs where traditional diagnostic tools fall short.

The findings reveal that out of the 50 specimens analyzed, 41 exhibited substantial clinical impact, providing essential insights that helped to resolve differential diagnoses, confirm disease recurrence, or indicate disease progression. Furthermore, the tests were instrumental in disease stratification and supported clinical trial preparations, particularly in cases where existing diagnostic methods lacked sensitivity or clarity.

Clinical Relevance of Summit and Vantage

The Summit test identified clinically relevant genetic variants in 64% (32 out of 50) of the specimens analyzed. Notably, the negative results from these tests also proved beneficial, as they helped rule out CNS lymphoma in several instances and confirmed successful therapy responses. In one highlighted case, Summit emerged as the sole test delivering actionable insights following inconclusive results from MRI, biopsy, and other blood-based tests.

The most frequently identified alterations within this cohort included MYD88, a significant marker for CNS lymphoma, followed by TP53 and CD79B. This underscores Summit's ability to pinpoint genetic changes critical for diagnosing the condition accurately. Additionally, findings of aneuploidy were clinically significant, revealing instances of potential metastatic CNS lymphoma that had no accompanying single nucleotide variants (SNVs). In two further cases, Summit provided longitudinal monitoring capabilities, suggesting a successful response to treatment based on the absence of previously detected variants.

Expert Insights on the Study

The clinical value of Summit and Vantage is further emphasized by experts in the field, such as Dr. Michael Youssef, a neuro-oncologist at the University of Texas Southwestern Medical Center. Dr. Youssef noted, "The Summit assay has enabled molecular diagnoses in patients who were unable to undergo surgery, providing actionable clarity without the need for tissue. The ability to longitudinally track variant allele frequency (VAF) has further strengthened our capacity to monitor treatment response in real-time."

Following the success of this study, Belay Diagnostics has expanded its testing portfolio with Summit 2.0, a more comprehensive version of the original test. This upgraded assay now adds 488 additional genes, covers copy number variations, identifies fusions, and measures tumor mutational burden and microsatellite instability, thereby enhancing its cerebrospinal fluid (CSF) profiling capabilities.

About Belay Diagnostics

Based in Chicago, Belay Diagnostics is dedicated to delivering innovative solutions for patients and their healthcare providers. With technology developed over a decade at Johns Hopkins University, Belay offers three proprietary CSF liquid biopsy tests: Summit™ 2.0, Ascent™, and Vantage™, each clinically verified against traditional tissue biopsy standards for more efficient diagnosis and management of CNS malignancies. These tests represent a minimally invasive alternative to traditional methods, including cytology and more invasive surgical interventions, enabling comprehensive molecular insights from a standard lumbar puncture.

For further details, visit Belay Diagnostics.