{"entity":{"id":"paper-lindeman-lung-molecular-testing-guideline-jto-2018","kind":"paper","name":"Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors","aka":[],"tldr":"Three professional bodies set out what every laboratory must test for in lung cancer, which sample types are acceptable, and when a blood test may stand in for a piece of tumour.","summary":"An expert panel convened by the College of American Pathologists, the International Association for the Study of Lung Cancer and the Association for Molecular Pathology systematically reviewed the evidence since the 2013 guideline and drafted 18 new recommendations while updating three. The 2013 guideline was largely reaffirmed, with updates allowing testing of cytology samples, requiring improved assay sensitivity and recommending against immunohistochemistry for EGFR testing. Key new recommendations include ROS1 testing for all patients with adenocarcinoma; the inclusion of ERBB2, MET, BRAF, KRAS and RET for laboratories that perform next-generation sequencing panels; immunohistochemistry as an alternative to fluorescence in situ hybridisation for ALK and ROS1 testing; assays with 5% sensitivity for EGFR T790M in patients with secondary resistance to EGFR inhibitors; and the use of cell-free DNA to rule in targetable mutations when tissue is limited or hard to obtain.","asOf":"2026-09-25","links":[{"label":"Lindeman et al., J Thorac Oncol 2018: the CAP, IASLC and AMP molecular testing guideline for lung cancer","url":"https://doi.org/10.1016/j.jtho.2017.12.001"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/29396253/"}],"tags":[],"related":["egfr-t790m","alk-fusion","ros1-fusion","met-ex14"],"cancers":["nsclc"],"sections":[],"technologies":["cgp","liquid-biopsy","histopathology-ihc","cytogenetics-fish","rna-seq"],"targets":["egfr","alk","ros1","ret","met","braf","kras","her2"],"drugs":[],"companies":[],"institutions":[],"pathways":["rtk-activation","nsclc-signalling"],"terms":["ngs","ihc","fish","ctdna","cfdna","biopsy","gene-fusion"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["journal-of-thoracic-oncology"],"dependsOn":[],"notes":[],"journal":"Journal of Thoracic Oncology","year":2018,"doi":"10.1016/j.jtho.2017.12.001","pmid":"29396253","authors":"Lindeman NI, Cagle PT, Aisner DL, et al.","paperType":"guideline","findings":["ROS1 testing recommended for every patient with lung adenocarcinoma.","Cell-free DNA may rule a mutation in but not out when tissue is limited.","Assays for EGFR T790M in acquired resistance must reach 5% sensitivity.","Immunohistochemistry is acceptable for ALK and ROS1 screening and not for EGFR."],"whatItMeans":"It is the document that defines what a complete lung cancer molecular report looks like, and its asymmetry about plasma, rule in but never rule out, is the single most useful sentence in it.","caveats":["Published before MET exon 14, RET fusion, KRAS G12C, HER2 exon 20 insertion and NTRK fusion indications became routine, so practice now exceeds the text.","It sets minimum standards rather than describing what laboratories actually do.","Recommendations on tissue stewardship are general rather than prescriptive."],"changedPractice":true},"route":"/key-papers/paper-lindeman-lung-molecular-testing-guideline-jto-2018/","neighbours":{"biomarker":[{"id":"alk-fusion","kind":"biomarker","name":"ALK fusion (ALK-positive)","route":"/biomarkers/alk-fusion/"},{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"},{"id":"egfr-l858r","kind":"biomarker","name":"EGFR L858R","route":"/biomarkers/egfr-l858r/"},{"id":"egfr-t790m","kind":"biomarker","name":"EGFR T790M","route":"/biomarkers/egfr-t790m/"},{"id":"met-ex14","kind":"biomarker","name":"MET exon 14 skipping mutation","route":"/biomarkers/met-ex14/"},{"id":"ret-fusion","kind":"biomarker","name":"RET fusion and RET mutation","route":"/biomarkers/ret-fusion/"},{"id":"ros1-fusion","kind":"biomarker","name":"ROS1 fusion (ROS1-positive)","route":"/biomarkers/ros1-fusion/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"cytogenetics-fish","kind":"technology","name":"Cytogenetics and FISH","route":"/technologies/cytogenetics-fish/"},{"id":"histopathology-ihc","kind":"technology","name":"Histopathology & immunohistochemistry","route":"/technologies/histopathology-ihc/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"target":[{"id":"alk","kind":"target","name":"ALK","route":"/targets/alk/"},{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"met","kind":"target","name":"MET","route":"/targets/met/"},{"id":"ret","kind":"target","name":"RET","route":"/targets/ret/"},{"id":"ros1","kind":"target","name":"ROS1","route":"/targets/ros1/"}],"pathway":[{"id":"nsclc-signalling","kind":"pathway","name":"Non-small cell lung cancer (KEGG map)","route":"/pathways/nsclc-signalling/"},{"id":"rtk-activation","kind":"pathway","name":"Receptor tyrosine kinase activation","route":"/pathways/rtk-activation/"}],"term":[{"id":"biopsy","kind":"term","name":"Biopsy","route":"/terms/biopsy/"},{"id":"cfdna","kind":"term","name":"Cell-free DNA (cfDNA)","route":"/terms/cfdna/"},{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"egfr-mutation-subtypes","kind":"term","name":"EGFR mutation subtypes (exon 19 deletion, L858R, exon 20 insertion, T790M)","route":"/terms/egfr-mutation-subtypes/"},{"id":"fish","kind":"term","name":"FISH / ISH (in situ hybridisation)","route":"/terms/fish/"},{"id":"gene-fusion","kind":"term","name":"Gene fusion","route":"/terms/gene-fusion/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"journal":[{"id":"journal-of-thoracic-oncology","kind":"journal","name":"Journal of Thoracic Oncology","route":"/journals/journal-of-thoracic-oncology/"}]}}