Evidence map›Paper›PMID 34215841›Full record

ArticleNPJ precision oncology2021

Validation of a liquid biopsy assay with molecular and clinical profiling of circulating tumor DNA.

Justin D Finkle, Hala Boulos, Terri M Driessen, Christine Lo, Richard A Blidner, Ashraf Hafez, Aly A Khan, Ariane Lozac'hmeur, Kelly E McKinnon, Jason Perera and 5 more

4 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in NPJ precision oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 54 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 5% of its field
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.

NCT05236114 recruitingnot on this mapstarted 2022, after this paper: background citation

TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Non-Small Cell Lung Cancer (NSCLC)

TypeobservationalSponsorTempus AIRan2022 to 2029Enrolled1,200ConditionsNon-Small Cell Lung CancerArmsObservation
NCT06163534 recruitingnot on this mapstarted 2024, after this paper: background citation

TEMPUS PHOENIX HNSCC STUDY: A Longitudinal Multi-Omic Biomarker Profiling Study of Patients With Head & Neck Squamous Cell Carcinoma (HNSCC)

Typeobservational_patient_registrySponsorTempus AIRan2024 to 2028Enrolled500ConditionsHead and Neck Squamous Cell Carcinoma
NCT06207032 recruitingnot on this mapstarted 2024, after this paper: background citation

TEMPUS ARIES: A Biobank Registry Platform Study in Oncology

TypeobservationalSponsorTempus AIRan2024 to 2029Enrolled500ConditionsCancer
NCT06997458 enrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Clinical Implementation of Liquid Biopsy in Cancer Through Next Generation Sequencing (NGS) Panels in the Andalusian Public Health System

TypeobservationalSponsorFundación Pública Andaluza para la Investigación Biomédica Andalucía OrientalRan2024 to 2026Enrolled500ConditionsNon Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)ArmsxF Tempus assay
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. High-Sensitivity ctDNA Analysis Uncovers Relevant Signals Missed by NGS in Pancreatic Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
  6. Liquid biopsy in solid tumours: expert opinion paper of the European society of pathology.Virchows Archiv : an international journal of pathology · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Shared PRAME epitopes are T-cell targets in NUT carcinoma.Journal for immunotherapy of cancer · 2026
    Article
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  16. Review
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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

15 authors at 2 institutions in 1 country.

Justin D Finkle *Tempus Labs, Chicago, IL, USA.ORCID http://orcid.org/0000-0001-7296-9855
Hala Boulos *Tempus Labs, Chicago, IL, USA.
Terri M Driessen *Tempus Labs, Chicago, IL, USA.
Christine Lo *Tempus Labs, Chicago, IL, USA.
Richard A BlidnerTempus Labs, Chicago, IL, USA.
Ashraf HafezTempus Labs, Chicago, IL, USA.
Aly A KhanTempus Labs, Chicago, IL, USA.
Ariane Lozac'hmeurTempus Labs, Chicago, IL, USA.
Kelly E McKinnonTempus Labs, Chicago, IL, USA.
Jason PereraTempus Labs, Chicago, IL, USA.
Wei ZhuTempus Labs, Chicago, IL, USA.
Afshin DowlatiUniversity Hospitals Seidman Cancer Center, Cleveland, OH, USA.
Kevin P WhiteTempus Labs, Chicago, IL, USA.
Robert TellTempus Labs, Chicago, IL, USA. bob@tempus.com.
Nike BeaubierTempus Labs, Chicago, IL, USA. Nike.Beaubier@tempus.com.ORCID http://orcid.org/0000-0002-5956-0198
Tempus Labs (United States) · USUniversity Hospitals Seidman Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Liquid biopsy is a valuable precision oncology tool that is increasingly used as a non-invasive approach to identify biomarkers, detect resistance mutations, monitor disease burden, and identify early recurrence. The Tempus xF liquid biopsy assay is a 105-gene, hybrid-capture, next-generation sequencing (NGS) assay that detects single-nucleotide variants, insertions/deletions, copy number variants, and chromosomal rearrangements. Here, we present extensive validation studies of the xF assay using reference standards, cell lines, and patient samples that establish high sensitivity, specificity, and accuracy in variant detection. The Tempus xF assay is highly concordant with orthogonal methods, including ddPCR, tumor tissue-based NGS assays, and another commercial plasma-based NGS assay. Using matched samples, we developed a dynamic filtering method to account for germline mutations and clonal hematopoiesis, while significantly decreasing the number of false-positive variants reported. Additionally, we calculated accurate circulating tumor fraction estimates (ctFEs) using the Off-Target Tumor Estimation Routine (OTTER) algorithm for targeted-panel sequencing. In a cohort of 1,000 randomly selected cancer patients who underwent xF testing, we found that ctFEs correlated with disease burden and clinical outcomes. These results highlight the potential of serial testing to monitor treatment efficacy and disease course, providing strong support for incorporating liquid biopsy in the management of patients with advanced disease.

Identifiers

PMID34215841
PMCPMC8253837
OpenAlexW3176446016

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.