#USA #Chicago #Belay Diagnostics #CNS Cancer #Summit 2.0

Revolutionizing CNS Cancer Diagnostics with Summit™ 2.0

Belay Diagnostics, a pioneering laboratory certified by both CLIA and CAP, has made significant strides in the detection of central nervous system (CNS) cancers. Their recent announcement highlights the validation of the Summit™ 2.0 Comprehensive Genomic Profile assay, a groundbreaking tool aimed at advancing precision medicine among CNS cancer patients.

A New Era of Cancer Detection

The Summit™ 2.0 assay stands out as the first liquid biopsy test of its kind that offers full clinical validation using cerebrospinal fluid (CSF) samples. Published in the peer-reviewed journal Cancers, the study involved analyzing the genetic profiles of 118 patients with various forms of CNS tumors, using samples not only matched with tissue biopsies but also from definitively diagnosed cases. This validation marks a critical milestone in liquid biopsy technology, which is essential when traditional tissue testing is not possible due to the challenging nature of CNS malignancies.

Brian Coe, co-founder and CEO of Belay Diagnostics, shared his excitement over the development, stating, "We're proud to make advanced testing like Summit™ 2.0 available to clinicians caring for patients with CNS cancers."

Advantages of the Summit™ 2.0 Assay

What makes the Summit™ 2.0 assay particularly innovative is its design, which enables comprehensive genomic profiling for CNS tumors derived from CSF. It addresses the inherent difficulties associated with tissue-based tests, especially given that CNS malignancies can often be inaccessible for biopsies. Furthermore, standard blood tests are limited by the blood-brain barrier, which complicates the effective use of plasma-based liquid biopsies.

By utilizing nucleic acid extracted directly from CSF, the Summit™ 2.0 assay can identify a plethora of clinically relevant biomarkers, spanning from single nucleotide variants (SNVs) and insertions/deletions (Indels) to more complex structures like copy number variants (CNVs) and fusions. The assay is also equipped to detect immunotherapy-related biomarkers, including tumor mutational burden (TMB) and microsatellite instability (MSI).

The analytical validation demonstrated a robust detection capability, revealing a sensitivity of 96.7% for SNVs and Indels, with an impressive specificity of 98% for CNS malignancy detection. These statistics emphasize the reliability of the Summit™ 2.0 assay in clinical settings.

A Comprehensive Clinical Validation

The clinical validation encompassed a diverse cohort, including gliomas, astrocytomas, glioblastomas, medulloblastomas, lymphomas, and metastatic cancers originating from solid tumors like lung and breast cancers. The 2.0 update provides improved detection yields when compared to the previous Summit™ 1.0, effectively identifying alterations in previously negative cases.

This comprehensive nature of testing not only provides crucial insights into tumor characteristics but also gives healthcare professionals actionable data for crafting personalized treatment plans. This is particularly significant in the realm of CNS cancers, where traditional therapies may often fall short.

Commitment to Patient Care

Belay Diagnostics is dedicated to transforming the diagnostic landscape for CNS cancers. Their suite of liquid biopsy tests, including Summit™, Ascent™, and Vantage™, enables detailed molecular characterization that enhances patient care through improved diagnostic accuracy, prognostic insights, and clinical trial options. With a vision centered around patient support, Belay aims to offer hope and direction to those facing the challenges of CNS tumors.

As neuroscience continues to evolve, tools like the Summit™ 2.0 assay promise to play an essential role in equipping clinicians with the knowledge necessary to combat CNS cancers effectively. As per Coe, their work underscores a commitment not just to scientific advancement but to the lives of the patients who rely on these innovations for their healthcare journey.