{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T18:08:37Z","timestamp":1759342117433,"version":"3.37.3"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T00:00:00Z","timestamp":1627948800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T00:00:00Z","timestamp":1627948800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Biocartis"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Diagn Pathol"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Quick and reliable testing of <jats:italic>EGFR<\/jats:italic> and <jats:italic>KRAS<\/jats:italic> is needed in non-small cell lung cancer (<jats:italic>NSCLC)<\/jats:italic> to ensure optimal decision-making for targeted therapy. The Idylla\u2122 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\u2122 platform for the detection of EGFR\/KRAS mutations in cytological <jats:italic>NSCLC<\/jats:italic> samples prepared as cytoblocks using AGAR and paraffin embedding.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Material and methods<\/jats:title>\n                <jats:p>The <jats:italic>KRAS<\/jats:italic> Idylla\u2122 test were performed on 11 specimens with a known <jats:italic>KRAS<\/jats:italic> mutation. The <jats:italic>EGFR<\/jats:italic> Idylla\u2122 test was performed on 18 specimens with a known primary <jats:italic>EGFR<\/jats:italic> mutation and 7 specimens with a primary EGFR-EGFR T790M resistance mutation combination.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Concordant <jats:italic>KRAS and primary EGFR<\/jats:italic> mutations were detected for both <jats:italic>KRAS<\/jats:italic> and primary <jats:italic>EGFR<\/jats:italic> mutations. Samples with a total CQ value of &lt;\u200926 could be considered negative. Samples with a total CQ value of &gt;\u200926 could not be assessed (probability of false-negative). In specimens with a primary <jats:italic>EGFR<\/jats:italic>-<jats:italic>EGFR<\/jats:italic> T790M resistance mutation combination, 5\/7 cases were not concordant.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Our results confirm the conclusion of recent reports that the Idylla\u2122EGFR 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. <jats:italic>KRAS<\/jats:italic> and primary <jats:italic>EGFR<\/jats:italic> mutations were detected using the Idylla\u2122 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.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13000-021-01121-3","type":"journal-article","created":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T07:03:19Z","timestamp":1627974199000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Short report: Performance evaluation of the Idylla\u2122 KRAS and EGFR mutation tests on paraffin-embedded\u00a0cytological NSCLC samples"],"prefix":"10.1186","volume":"16","author":[{"given":"Saskia","family":"Offerman","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clemens F.","family":"Prinsen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ageeth","family":"Knol","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Natalie","family":"Methorst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeanette","family":"Kamphorst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1412-0065","authenticated-orcid":false,"given":"Maarten","family":"Niemantsverdriet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,8,3]]},"reference":[{"key":"1121_CR1","doi-asserted-by":"publisher","unstructured":"Garinet S, Laurent-Puig P, Blons H, Oudart JB. 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As a result of this review, the committee concluded that the rules laid down in the Medical\u00a0Research Involving Human Subjects (also known by its Dutch abbreviation WMO), do not apply to this research.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable (see above).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no conflict of interest.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"70"}}