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

CHICAGO, March 24, 2026 /PRNewswire/ -- Belay Diagnostics announced the publication of a new retrospective study demonstrating that its Summit and Vantage tests provided meaningful clinical impact in 82% of CNS lymphoma cases evaluated. The study, which analyzed 50 specimens from 48 patients during the first 12 months of commercial availability, found that Summit and Vantage helped resolve differential diagnoses, confirm recurrence or progression, aid in disease stratification, and support clinical trial workups in cases where existing standard-of-care tools were limited in scope and sensitivity.

Summit and Vantage provided meaningful clinical impact in 41 of 50 specimens (82%), including resolving differential diagnoses, informing diagnosis, confirming recurrence or progression, aiding in disease stratification, and supporting clinical trial workups. Summit detected clinically relevant variants in 64% (32 of 50) of specimens, and negative results also proved informative in several cases, helping rule out CNS lymphoma or confirm successful response to therapy. In one case highlighted in the publication, Summit was the only test that provided actionable information after MRI, biopsy, and blood-based testing all returned indeterminate results. The full study, published in Lymphatics, is available here.

The most commonly detected alterations in this cohort were MYD88, a hallmark of CNS lymphoma, followed by TP53 and CD79B, demonstrating that Summit can identify alterations critical to CNS lymphoma diagnosis. Aneuploidy findings were also clinically significant: several cases with concern for metastatic CNS lymphoma showed five or more aneuploidy events with no accompanying SNVs, supporting concern for CNS metastasis. In two additional cases, Summit was used for longitudinal monitoring, and the absence of previously detected variants suggested successful response to therapy.

The findings underscore the clinical value of Summit and Vantage in CNS lymphoma, particularly in cases where other diagnostic methods are negative, non-diagnostic, or indeterminate. Michael Youssef, MD, a neuro-oncologist at the University of Texas Southwestern Medical Center, has seen this firsthand: "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." Since this study was conducted, Belay has expanded its offering with Summit 2.0, which adds 488 additional genes, copy number variants, fusions, tumor mutational burden, and microsatellite instability to its CSF profiling capabilities.

About Belay Diagnostics: Belay Diagnostics is a Chicago-based laboratory dedicated to serving patients and the clinicians who care for them. Using licensed technology developed through more than 10 years of scientific research at Johns Hopkins University, Belay has developed three proprietary CSF liquid biopsy tests – Summit™ 2.0, Ascent™, and Vantage™ – each clinically validated against the gold standard of tissue biopsy to help inform the diagnosis and management of primary and secondary CNS malignancies. Belay's tests offer a minimally invasive alternative to cytology, imaging, and brain biopsy, providing clinicians with comprehensive molecular insights from a standard lumbar puncture. For more information, visit www.belaydiagnostics.com.

SOURCE Belay Diagnostics