Evidence map›Paper›PMID 37762091›Full record

ArticleInternational journal of molecular sciences2023

European Real-World Assessment of the Clinical Validity of a CE-IVD Panel for Ultra-Fast Next-Generation Sequencing in Solid Tumors.

Nicola Normanno, José Carlos Machado, Edoardo Pescarmona, Simonetta Buglioni, Lara Navarro, Riziero Esposito Abate, Anabela Ferro, Rob Mensink, Matilde Lambiase, Virginie Lespinet-Fabre and 4 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
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

14 authors at 5 institutions in 5 countries.

Nicola NormannoCell Biology and Biotherapy Unit, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, 80131 Naples, Italy.
José Carlos MachadoInstituto de Investigação e Inovação em Saúde (i3S), University of Porto, 4200-135 Porto, Portugal.ORCID 0000-0003-4741-8415
Edoardo PescarmonaI.R.C.C.S. Regina Elena National Cancer Institute, 00144 Rome, Italy.
Simonetta BuglioniI.R.C.C.S. Regina Elena National Cancer Institute, 00144 Rome, Italy.ORCID 0000-0002-5066-1523
Lara NavarroConsorcio Hospital General de Valencia, 46014 Valencia, Spain.ORCID 0000-0002-0786-4333
Riziero Esposito AbateCell Biology and Biotherapy Unit, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, 80131 Naples, Italy.ORCID 0000-0001-7621-1320
Anabela FerroInstituto de Investigação e Inovação em Saúde (i3S), University of Porto, 4200-135 Porto, Portugal.ORCID 0000-0001-6042-4591
Rob MensinkInstituto de Investigação e Inovação em Saúde (i3S), University of Porto, 4200-135 Porto, Portugal.
Matilde LambiaseCell Biology and Biotherapy Unit, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, 80131 Naples, Italy.
Virginie Lespinet-FabreLaboratory of Clinical and Experimental Pathology, Biobank BB-0033-00025, FHU OncoAge, IHU RespirERA, CHU de Nice, Université Côte d'Azur, 06000 Nice, France.
Byron CalguaInstitute of Pathology, University Hospital Basel, 4031 Basel, Switzerland.
Philip M JermannInstitute of Pathology, University Hospital Basel, 4031 Basel, Switzerland.ORCID 0000-0002-8836-4946
Marius IliéLaboratory of Clinical and Experimental Pathology, Biobank BB-0033-00025, FHU OncoAge, IHU RespirERA, CHU de Nice, Université Côte d'Azur, 06000 Nice, France.ORCID 0000-0002-2014-1236
Paul HofmanLaboratory of Clinical and Experimental Pathology, Biobank BB-0033-00025, FHU OncoAge, IHU RespirERA, CHU de Nice, Université Côte d'Azur, 06000 Nice, France.ORCID 0000-0003-0431-9353
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITUniversidade do Porto · PTUniversité Côte d'Azur · FRUniversity Hospital of Basel · CHHospital General Universitario De Valencia · ES

Funding

Thermo Fisher Scientific na
6 · The paper itself

Abstract

Molecular profiling of solid tumors facilitates personalized, targeted therapeutic interventions. The ability to perform next-generation sequencing (NGS), especially from small tissue samples, in a short turnaround time (TAT) is essential to providing results that enable rapid clinical decisions. This multicenter study evaluated the performance of a CE in vitro diagnostic (IVD) assay, the Oncomine Dx Express Test, on the Ion Torrent Genexus System for detecting DNA and RNA variants in solid tumors. Eighty-two archived formalin-fixed paraffin embedded (FFPE) tissue samples from lung, colorectal, central nervous system, melanoma, breast, gastric, thyroid, and soft tissue cancers were used to assess the presence of single nucleotide variants (SNVs), insertions and deletions (indels), copy number variations (CNVs), gene fusions, and splice variants. These clinical samples were previously characterized at the various academic centers using orthogonal methods. The Oncomine Dx Express Test showed high performance with 100% concordance with previous characterization for SNVs, indels, CNVs, gene fusions, and splice variants. SNVs and indels with allele frequencies as low as 5% were correctly identified. The test detected all the expected

Indexed as

DNA Copy Number VariationsMelanomaHigh-Throughput Nucleotide SequencingHumansProtein-Tyrosine KinasesProto-Oncogene ProteinsProtein-Tyrosine KinasesProto-Oncogene ProteinsbiomarkersCE-IVDmolecular profilingnext-generation sequencingOncomine Dx Express Test

Identifiers

PMID37762091
PMCPMC10531166
OpenAlexW4386526477

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.