Evidence map›Paper›PMID 34344387›Full record

ArticleDiagnostic pathology2021

Short report: Performance evaluation of the Idylla™ KRAS and EGFR mutation tests on paraffin-embedded cytological NSCLC samples.

Saskia Offerman, Clemens F Prinsen, Ageeth Knol, Natalie Methorst, Jeanette Kamphorst, Maarten Niemantsverdriet

Open access · goldAbstract readEvaluation Study
In one paragraph

Article in Diagnostic pathology, 2021. 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
0.4field-weighted citation impact, top 35% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

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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

6 authors at 2 institutions in 1 country.

Saskia Offerman *Isala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands.
Clemens F Prinsen *Isala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands.
Ageeth KnolIsala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands.
Natalie MethorstIsala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands.
Jeanette KamphorstIsala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands.
Maarten NiemantsverdrietIsala Pathology, Dr. Van Heesweg 2, 8025 AB Zwolle, Postbus 10400, 8000 GK, Zwolle, The Netherlands. m.niemantsverdriet@isala.nl.ORCID http://orcid.org/0000-0003-1412-0065
Isala · NLCanisius-Wilhelmina Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuick and reliable testing of EGFR and KRAS is needed in non-small cell lung cancer (NSCLC) to ensure optimal decision-making for targeted therapy. The Idylla™ platform was designed for Formalin-Fixed Paraffin-Embedded (FFPE) tissue sections but recently several studies were published that evaluated its potential for cytological specimens. This study aimed to validate the Idylla™ platform for the detection of EGFR/KRAS mutations in cytological NSCLC samples prepared as cytoblocks using AGAR and paraffin embedding. MATERIAL AND

methodsThe KRAS Idylla™ test were performed on 11 specimens with a known KRAS mutation. The EGFR Idylla™ test was performed on 18 specimens with a known primary EGFR mutation and 7 specimens with a primary EGFR-EGFR T790M resistance mutation combination.

resultsConcordant KRAS and primary EGFR mutations were detected for both KRAS and primary EGFR mutations. Samples with a total CQ value of < 26 could be considered negative. Samples with a total CQ value of > 26 could not be assessed (probability of false-negative). In specimens with a primary EGFR-EGFR T790M resistance mutation combination, 5/7 cases were not concordant.

conclusionOur results confirm the conclusion of recent reports that the Idylla™EGFR assay is not suitable in a resistance to EGFR TKI setting, also not in our cytological NSCLC samples prepared as cytoblocks using AGAR and paraffin embedding. KRAS and primary EGFR mutations were detected using the Idylla™ assays in virtually all cytological NSCLC samples. This analysis was rapid and time-saving compared to other mutation detection assays and may be useful if the amount of material is insufficient to perform a full set of molecular tests.

Indexed as

AdenocarcinomaAgarBiomarkers, TumorCarcinoma, Non-Small-Cell LungFixativesFormaldehydeGenes, erbB-1Genetic TestingHumansLung NeoplasmsMutationParaffin EmbeddingProto-Oncogene Proteins p21(ras)Real-Time Polymerase Chain ReactionTissue FixationAgarBiomarkers, TumorFixativesFormaldehydeKRAS protein, humanProto-Oncogene Proteins p21(ras)

Identifiers

PMID34344387
PMCPMC8330063
OpenAlexW3192798768

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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.