Belay Diagnostics CSF liquid biopsy for CNS malignancy diagnosis and monitoring

Belay Summit 2.0 Comprehensive Genomic Profile

Tumor-derived nucleic acid in CSF

  • Next-generation sequencing
  • 520 genes (SNVs, MNVs, Indels)​
  • 62 CNVs​
  • 28 Fusions​
  • TMB and MSI
Why Choose Summit — Dynamic

Why choose Summit 2.0?

Actionable molecular insights from CSF, no surgery required

Supports diagnosis, treatment selection, response, and longitudinal monitoring

Validated against tissue biopsy and peer-reviewed

Results in 10–14 calendar days

Recommended in Clinical Practice Guidelines

The major clinical practice guidelines in oncology have been updated to recommend CSF-based genomic profiling for 5 cancer types:

Inoperable high-grade gliomas and glioblastomas Medulloblastomas Ependymomas Primary CNS lymphoma Leptomeningeal metastases

Unmatched Clinical Sensitivity

Summit 2.0 was clinically validated against tissue biopsy and matches its results.

Performance Bars — Tabbed
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Why CSF?

  • Direct contact with CNS tumors makes CSF the ideal specimen for detecting tumor-derived DNA.
  • Purpose-built for the CNS microenvironment, not adapted from plasma-based platforms.
  • Validated against tissue biopsy results.

Large-Scale Gene Profile Addresses Clinical Needs

Genes and Genomic Biomarkers
Black and white photo of a mountain ridge with climbers in the distance

Traditional CNS tumor detection methods have limitations​

CSF CYTOLOGY

  • Low sensitivity
  • Excludes genomic data

CNS IMAGING

  • Lacks specificity in differentiating cancer from inflammatory or non-neoplastic conditions
  • Lacks personalized molecular data

BRAIN BIOPSY

  • Highly invasive, risk of hemorrhage, neurological injury, stroke, death
  • Nondiagnostic in 10-17% of cases4,5
  • Significant inter and intra-tumoral heterogeneity 
  • Biopsy infeasible: brain stem, spinal cord, optic pathway, diffuse midline gliomas, comorbidities

Assay Specifications

Assay Specifications — Tabbed

Collect ≥ 6 mL of CSF in your institution’s standard CSF tubes. Samples < 6 mL will be processed and results reported if established reporting thresholds are met. Wrap tubes in Parafilm, if available, to prevent leakage. Label each tube with the collection date and two unique patient identifiers matching those on Test Requisition Form (TRF).

Shipping within 24 hours of collection: Maintain specimens at room temperature. Specimens must be received at Belay within 4 calendar days of collection.

Shipping 1–3 days after collection: Refrigerate within 4–6 hours of collection. Ship at ambient temperature. Specimens must be received at Belay within 2 calendar days of shipment.

Shipping after more than 3 days: Freeze at -80°C within 4–6 hours of collection. Ship on dry ice. Note, frozen samples cannot be shipped in Belay shipping kits and require alternate shipping containers provided by the client.

Open Belay shipping kit and remove contents. Activate temperature tracker and attach to biohazard bag. Insert labeled tubes into absorbent sleeve, place in biohazard bag, and seal. Wrap the gel blanket around the biohazard bag, place inside Styrofoam container, and close lid. Place the TRF, signed informed consent, and any clinical reports on top of Styrofoam container and close outer lid. Place kit inside provided FedEx bag, seal, add FedEx label, and schedule pickup or include in your standard pickup procedures.

Next-generation sequencing

Include TRF in shipping kit or fax form to 800-501-9246. Test results available via fax, encrypted email, or Belay portal.

Average 10–14 days from receipt of specimen

Collect ≥ 6 mL of CSF in your institution’s standard CSF tubes. Samples < 6 mL will be processed and results reported if established reporting thresholds are met. Wrap tubes in Parafilm, if available, to prevent leakage. Label each tube with the collection date and two unique patient identifiers matching those on Test Requisition Form (TRF).

Shipping within 24 hours of collection: Maintain specimens at room temperature. Specimens must be received at Belay within 4 calendar days of collection.

Shipping 1–3 days after collection: Refrigerate within 4–6 hours of collection. Ship at ambient temperature. Specimens must be received at Belay within 2 calendar days of shipment.

Shipping after more than 3 days: Freeze at -80°C within 4–6 hours of collection. Ship on dry ice. Note, frozen samples cannot be shipped in Belay shipping kits and require alternate shipping containers provided by the client.

Open Belay shipping kit and remove contents. Activate temperature tracker and attach to biohazard bag. Insert labeled tubes into absorbent sleeve, place in biohazard bag, and seal. Wrap the gel blanket around the biohazard bag, place inside Styrofoam container, and close lid. Place the TRF, signed informed consent, and any clinical reports on top of Styrofoam container and close outer lid. Place kit inside provided FedEx bag, seal, add FedEx label, and schedule pickup or include in your standard pickup procedures.

Next-generation sequencing

Include TRF in shipping kit or fax form to 800-501-9246. Test results available via fax, encrypted email, or Belay portal.

Average 10–14 days from receipt of specimen

References:  1. Park SH, Won J, Kim SI, Lee Y, Park CK, Kim SK, Choi SH. Molecular Testing of Brain Tumor. J Pathol Transl Med. 2017 May;51(3):205-223. doi: 10.4132/jptm.2017.03.08. Epub 2017 May 12. PMID: 28535583; PMCID: PMC5445205.  2. Shen E, Van Swearingen AED, Price MJ, Bulsara K, Verhaak RGW, Baëta C, Painter BD, Reitman ZJ, Salama AKS, Clarke JM, Anders CK, Fecci PE, Goodwin CR, Walsh KM. A Need for More Molecular Profiling in Brain Metastases. Front Oncol. 2022 Jan 25;11:785064. doi: 10.3389/fonc.2021.785064. PMID: 35145903; PMCID: PMC8821807.  3. DOI: 10.1016/j.jmoldx.2025.03.010  4. Bander, E.D., Jones, S.H., Pisapia, D. et al. Tubular brain tumor biopsy improves diagnostic yield for subcortical lesions. J Neurooncol 141, 121–129 (2019). https://doi.org/10.1007/s11060-018-03014-w  5. Malone H, Yang J, Hershman DL, Wright JD, Bruce JN, Neugut AI. Complications Following Stereotactic Needle Biopsy of Intracranial Tumors. World Neurosurg. 2015;84(4):1084-1089. doi:10.1016/j.wneu.2015.05.025  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed December 23, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org.

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Let Us Help You Get Started

The future of genomic testing in CSF is here. Our team is ready to support you with test ordering, clinical questions, and patient resources.