Evidence map›Paper›PMID 25341115›Full record

ReviewGenetics in medicine : official journal of the American College of Medical Genetics2015

An overview of recommendations and translational milestones for genomic tests in cancer.

Christine Q Chang, Sharna R Tingle, Kelly K Filipski, Muin J Khoury, Tram Kim Lam, Sheri D Schully, John P A Ioannidis

Abstract readReview
In one paragraph

Review in Genetics in medicine : official journal of the American College of Medical Genetics, 2015. 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. Evidence-based medicine and big genomic data.Human molecular genetics · 2018
    Review
  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

7 authors.

Christine Q ChangEpidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA.ORCID 000000024624898X
Sharna R TingleEpidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA.
Kelly K FilipskiEpidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA.
Muin J Khoury1] Epidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA [2] Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Tram Kim LamEpidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA.
Sheri D SchullyEpidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA.
John P A Ioannidis1] Epidemiology and Genomics Research Program, National Cancer Institute, Rockville, Maryland, USA [2] Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA [3] Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California, USA [4] Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, California, USA.

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

purposeTo understand the translational trajectory of genomic tests in cancer screening, diagnosis, prognosis, and treatment, we reviewed tests that have been assessed by recommendation and guideline developers.

methodsFor each test, we marked translational milestones by determining when the genomic association with cancer was first discovered and studied in patients, and when a health application for a specified clinical use was successfully demonstrated and approved or cleared by the US Food and Drug Administration. To identify recommendations and guidelines, we reviewed the websites of cancer, genomic, and general guideline developers and professional organizations. We searched the in vitro diagnostics database of the US Food and Drug Administration for information, and we searched PubMed for translational milestones. Milestones were examined against type of recommendation, Food and Drug Administration approval or clearance, disease rarity, and test purpose.

resultsOf the 45 tests we identified, 9 received strong recommendations for their usage in clinical settings, 14 received positive but moderate recommendations, and 22 were not currently recommended. For 18 tests, two or more different sources had issued recommendations, with 67% concordance. Only five tests had Food and Drug Administration approval, and an additional five had clearance. The median time from discovery to recommendation statement was 14.7 years.

conclusionIn general, there were no associations found between translational trajectory and recommendation category.Genet Med 17 6, 431-440.

Indexed as

Diagnostic Test ApprovalEarly Detection of CancerGenetic TestingGenomicsHumansNeoplasmsTranslational Research, BiomedicalUnited StatesUnited States Food and Drug Administration

Identifiers

PMID25341115
PMCPMC4686861

What OpenQuestion holds

Textmetadata
LicenceTDM
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.