Evidence map›Paper›PMID 30794985›Full record

ArticleThe Journal of molecular diagnostics : JMD2019

Analytical Validation of Variants to Aid in Genotype-Guided Therapy for Oncology.

Marelize Swart, Wesley M Stansberry, Victoria M Pratt, Elizabeth B Medeiros, Patrick J Kiel, Fei Shen, Bryan P Schneider, Todd C Skaar

Abstract readValidation Study
In one paragraph

Article in The Journal of molecular diagnostics : JMD, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

8 authors.

Marelize SwartDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana.
Wesley M StansberryDepartment of Medicine, Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana.
Victoria M PrattDepartment of Medicine, Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana. Electronic address: vpratt@iu.edu.
Elizabeth B MedeirosDepartment of Medicine, Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana.
Patrick J KielDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana.
Fei ShenDivision of Hematology/Oncology, Indiana University School of Medicine, Indianapolis, Indiana.
Bryan P SchneiderDivision of Hematology/Oncology, Indiana University School of Medicine, Indianapolis, Indiana.
Todd C SkaarDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana.

Funding

Embedding Pharmacogenotyping in an Integrated Health System for the UnderservedU01HG007762 · NHGRI · INDIANA UNIVERSITY INDIANAPOLIS · PI DEXTER, PAUL, SKAAR, TODD C. · 2014 to 2018
$4.4M
NHGRI NIH HHS U01 HG007762
6 · The paper itself

Abstract

The Clinical Laboratory Improvement Amendments of 1988 require that pharmacogenetic genotyping methods need to be established according to technical standards and laboratory practice guidelines before testing can be offered to patients. Testing methods for variants in ABCB1, CBR3, COMT, CYP3A7, C8ORF34, FCGR2A, FCGR3A, HAS3, NT5C2, NUDT15, SBF2, SEMA3C, SLC16A5, SLC28A3, SOD2, TLR4, and TPMT were validated in a Clinical Laboratory Improvement Amendments-accredited laboratory. Because no known reference materials were available, existing DNA samples were used for the analytical validation studies. Pharmacogenetic testing methods developed here were shown to be accurate and 100% analytically sensitive and specific. Other Clinical Laboratory Improvement Amendments-accredited laboratories interested in offering pharmacogenetic testing for these genetic variants, related to genotype-guided therapy for oncology, could use these publicly available samples as reference materials when developing and validating new genetic tests or refining current assays.

Indexed as

GenotypeGenotyping TechniquesGerm-Line MutationHumansMutationNeoplasmsSensitivity and Specificity

Identifiers

PMID30794985
PMCPMC6504676

What OpenQuestion holds

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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.