Evidence map›Paper›PMID 27455875›Full record

ArticleThe Journal of molecular diagnostics : JMD2016

Certified DNA Reference Materials to Compare HER2 Gene Amplification Measurements Using Next-Generation Sequencing Methods.

Chih-Jian Lih, Han Si, Biswajit Das, Robin D Harrington, Kneshay N Harper, David J Sims, Paul M McGregor, Corinne E Camalier, Andrew Y Kayserian, P Mickey Williams and 5 more

Open access · hybridAbstract read
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.7field-weighted citation impact, top 17% 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.

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

13 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. HER2 mRNA transcript quantitation in breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2017
    Article
  10. Analytic Response Curves of Clinical Breast Cancer IHC Tests.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2017
    Article
  11. Perspectives of HER2-targeting in gastric and esophageal cancer.Expert opinion on investigational drugs · 2017
    Review
  12. A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry.Applied immunohistochemistry & molecular morphology : AIMM
    Article
  13. 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

15 authors at 2 institutions in 1 country.

Chih-Jian LihMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Han SiMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Biswajit DasMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Robin D HarringtonMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Kneshay N HarperMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
David J SimsMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Paul M McGregorMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Corinne E CamalierMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Andrew Y KayserianMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
P Mickey WilliamsMolecular Characterization and Clinical Assay Development Laboratory, Frederick National Laboratory for Cancer Research, Frederick, Maryland.
Hua-Jun HeDivision of Biosystems and Biomaterials, National Institute of Standards and Technology, Gaithersburg, Maryland.
Jamie L AlmeidaDivision of Biosystems and Biomaterials, National Institute of Standards and Technology, Gaithersburg, Maryland.
Steve P LundDivision of Statistical Engineering, National Institute of Standards and Technology, Gaithersburg, Maryland.
Steve ChoquetteDivision of Biosystems and Biomaterials, National Institute of Standards and Technology, Gaithersburg, Maryland.
Kenneth D ColeDivision of Biosystems and Biomaterials, National Institute of Standards and Technology, Gaithersburg, Maryland. Electronic address: kenneth.cole@nist.gov.
Frederick National Laboratory for Cancer Research · USNational Institute of Standards and Technology · US

Funding

CCR NIH HHS HHSN261200800001CNCI NIH HHS HHSN261200800001E
6 · The paper itself

Abstract

The National Institute of Standards and Technology (NIST) Standard Reference Materials 2373 is a set of genomic DNA samples prepared from five breast cancer cell lines with certified values for the ratio of the HER2 gene copy number to the copy numbers of reference genes determined by real-time quantitative PCR and digital PCR. Targeted-amplicon, whole-exome, and whole-genome sequencing measurements were used with the reference material to compare the performance of both the laboratory steps and the bioinformatic approaches of the different methods using a range of amplification ratios. Although good reproducibility was observed in each next-generation sequencing method, slightly different HER2 copy numbers associated with platform-specific biases were obtained. This study clearly demonstrates the value of Standard Reference Materials 2373 as reference material and as a calibrator for evaluating assay performance as well as for increasing confidence in reporting HER2 amplification for clinical applications.

Indexed as

Gene AmplificationHigh-Throughput Nucleotide SequencingReference StandardsCell Line, TumorErb-b2 Receptor Tyrosine KinasesExomeFemaleGene DosageGenome, HumanHumansMaleNeoplasmsReal-Time Polymerase Chain ReactionErb-b2 Receptor Tyrosine Kinases

Identifiers

PMID27455875
PMCPMC5397679
OpenAlexW2493018502

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.