Evidence map›Paper›PMID 39966612›Full record

ArticleScientific reports2025

Molecular counting enables accurate and precise quantification of methylated ctDNA for tumor-naive cancer therapy response monitoring.

Patrick Peiyong Ye, Robb Viens, Katherine E Shelburne, Sydne Scot Langpap, Xavier S Bower, Jonathan Jiahui Shi, Wen Zhou, Jan Christian Wignall, Joyce Jiawei Zhu, Brian D Woodward and 3 more

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Using cell-free DNA tumor methylation score to detect and monitor cholangiocarcinoma.HPB : the official journal of the International Hepato Pancreato Biliary Association · 2026
    Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
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

13 authors.

Patrick Peiyong YeBillionToOne, Inc, Menlo Park, CA, USA. patrick@billiontoone.com.
Robb ViensBillionToOne, Inc, Menlo Park, CA, USA.
Katherine E ShelburneBillionToOne, Inc, Menlo Park, CA, USA.
Sydne Scot LangpapBillionToOne, Inc, Menlo Park, CA, USA.
Xavier S BowerBillionToOne, Inc, Menlo Park, CA, USA.
Jonathan Jiahui ShiBillionToOne, Inc, Menlo Park, CA, USA.
Wen ZhouBillionToOne, Inc, Menlo Park, CA, USA.
Jan Christian WignallBillionToOne, Inc, Menlo Park, CA, USA.
Joyce Jiawei ZhuBillionToOne, Inc, Menlo Park, CA, USA.
Brian D WoodwardUniversity of California San Diego Moores Cancer Center, La Jolla, CA, USA.
Hatim HusainUniversity of California San Diego Moores Cancer Center, La Jolla, CA, USA.
David S TsaoBillionToOne, Inc, Menlo Park, CA, USA.
Oguzhan AtayBillionToOne, Inc, Menlo Park, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Personalized cancer treatment can significantly extend survival and improve quality of life for many patients, but accurate and real-time therapy response monitoring remains challenging. To overcome logistical and technical challenges associated with therapy response monitoring via imaging scans or assays that track the variant allele fraction (VAF) of somatic mutations in circulating tumor DNA (ctDNA), we developed a tumor-naive liquid biopsy assay that leverages Quantitative Counting Template (QCT) technology to accurately and precisely quantify methylated ctDNA (Northstar Response™). The assay achieves < 10% coefficient of variation at 1% tumor fraction, which is 2 × lower than tumor-naive, targeted-panel approaches using VAF. The assay accurately distinguishes 0.25% absolute changes in contrived tumor fraction (AUC > 0.94) and performs well in 12 solid tumor types. Finally, in a small cohort of patients with lung, colorectal, or pancreatic cancer, the assay detected changes in ctDNA methylation that correlate with clinical outcomes. With its precise quantification of ctDNA methylation, Northstar Response is a novel tool for therapy response monitoring with the potential to inform clinical decision making for cancer treatment.

Indexed as

Biomarkers, TumorCirculating Tumor DNAColorectal NeoplasmsDNA MethylationLung NeoplasmsPancreatic NeoplasmsAllelesComputational BiologyGenetic VariationHumansLiquid BiopsyMutationBiomarkers, TumorCirculating Tumor DNA

Identifiers

PMID39966612
PMCPMC11836444

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Registered trials

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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.