Evidence map›Paper›PMID 40280408›Full record

ArticleThe Journal of molecular diagnostics : JMD2025

Analytical Validation and Clinical Sensitivity of the Belay Summit Assay for the Detection of DNA Variants in Cerebrospinal Fluid of Primary and Metastatic Central Nervous System Cancer.

Qian Nie, Kala F Schilter, Kyle M Hernandez, Jennifer N Adams, Rakshitha Jagadish, Anthony Acevedo, Alexandra Larson, Brett A Domagala, Samantha A Vo, Sakshi Khurana and 8 more

Abstract read
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Qian NieBelay Diagnostics, Chicago, Illinois.
Kala F SchilterBelay Diagnostics, Chicago, Illinois.
Kyle M HernandezBelay Diagnostics, Chicago, Illinois.
Jennifer N AdamsBelay Diagnostics, Chicago, Illinois.
Rakshitha JagadishBelay Diagnostics, Chicago, Illinois.
Anthony AcevedoBelay Diagnostics, Chicago, Illinois.
Alexandra LarsonBelay Diagnostics, Chicago, Illinois.
Brett A DomagalaBelay Diagnostics, Chicago, Illinois.
Samantha A VoBelay Diagnostics, Chicago, Illinois.
Sakshi KhuranaBelay Diagnostics, Chicago, Illinois.
Kathleen MitchellBelay Diagnostics, Chicago, Illinois.
Dean EllisBelay Diagnostics, Chicago, Illinois.
Baymuhammet MuhammedovBelay Diagnostics, Chicago, Illinois.
Yuxuan WangBelay Diagnostics, Chicago, Illinois.
Christopher DouvilleBelay Diagnostics, Chicago, Illinois.
Brian CoeBelay Diagnostics, Chicago, Illinois.
Chetan BettegowdaBelay Diagnostics, Chicago, Illinois.
Honey V ReddiBelay Diagnostics, Chicago, Illinois. Electronic address: hreddi@belaydiagnostics.com.

Funding

Multi-omic CSF Assay for the Diagnosis of Brain CancersR42NS135834 · NINDS · BELAY DIAGNOSTICS, LLC · PI CHETAN BETTEGOWDA, Brian Coe · 2024 to 2026
$2.1M
NINDS NIH HHS R42 NS135834
6 · The paper itself

Abstract

In contrast to most solid tumors, cancers of the central nervous system (CNS) pose a unique challenge for effective detection and tracking via plasma because of the blood-brain barrier. Informed diagnosis of primary and metastatic CNS tumors can be facilitated using a liquid biopsy assay that evaluates tumor-derived DNA from the cerebrospinal fluid (CSF), potentially increasing the efficacy of diagnosis and reducing the uncertainty and morbidities associated with the current standard of care that involves neurosurgical procedures. The Belay Summit assay involves tumor-derived DNA-based genomic profiling of CSF to inform diagnosis of CNS tumors. The analytical sensitivity of Summit for single-nucleotide/multinucleotide variants and insertions/deletions is 96% at a 95% limit of detection of 0.30% variant allele fraction. Analytical sensitivity for chromosomal arm-level aneuploidy is 91% at abs(log2r) of 0.09 limit of detection. Clinical sensitivity across a cohort of 124 specimens, including primary and metastatic CNS tumors, was demonstrated to be 90% with a specificity of 95%, supporting the potential for positive clinical utility. These results demonstrate that the Belay Summit assay can accurately and reproducibly be used to inform the diagnosis of primary and metastatic CNS tumors using CSF.

Indexed as

Biomarkers, TumorCentral Nervous System NeoplasmsDNA, NeoplasmHumansLiquid BiopsyPolymorphism, Single NucleotideReproducibility of ResultsSensitivity and SpecificityBiomarkers, TumorDNA, Neoplasm

Identifiers

PMID40280408
PMCPMC12264565

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.