BACKGROUND: Two types of @entity470 ( @entity470 ) mutations in exon 19 and exon 21 (ex19del and @entity9512 ) are prevalent in @entity2 @entity1 and sensitive to targeted @entity470 inhibition. A resistance mutation in exon 20 ( @entity9513 ) has been found to accompany drug treatment when @entity1 relapse. These three mutations are valuable companion diagnostic biomarkers for guiding personalized treatment. Quantitative polymerase chain reaction (qPCR)-based methods have been widely used in the clinic by physicians to guide treatment decisions. The aim of this study was to evaluate the technical and clinical sensitivity and specificity of the droplet digital polymerase chain reaction (ddPCR) method in detecting the three @entity470 mutations in @entity1 with @entity2 . METHODS: Genomic DNA from H1975 and PC-9 cells, as well as 92 normal @entity1 blood specimens, was used to determine the technical sensitivity and specificity of the ddPCR assays. Genomic DNA of @entity406 -fixed, @entity982 -embedded specimens from 78 Chinese @entity1 with @entity2220 were assayed using both qPCR and ddPCR. RESULTS: The three ddPCR assays had a limit of detection of 0.02% and a wide dynamic range from 1 to 20,000 copies measurement. The @entity9512 and ex19del assays had a 0% background level in the technical and clinical settings. The @entity9513 assay appeared to have a 0.03% technical background. The ddPCR assays were robust for correct determination of @entity470 mutation status in @entity1 , and the dynamic range appeared to be better than qPCR methods. The ddPCR assay for @entity9513 could detect @entity1 samples that the qPCR method failed to detect. About 49% of this @entity1 cohort had @entity470 mutations ( @entity9512 , 15.4%; ex19del, 29.5%; @entity9513 , 6.4%). Two @entity1 with the ex19del mutation also had a na  ve @entity9513 mutation. CONCLUSION: These data suggest that the ddPCR method could be useful in the personalized treatment of @entity1 with @entity2 .

Detection of @entity470 mutation in XXXX by droplet digital polymerase chain reaction.

@entity1 :: ('9606', 'Species') :: ['human', 'patients', 'patient'] @entity470 :: ('1956', 'Gene') :: ['EGFR', 'epidermal growth factor receptor'] @entity2 :: ('MESH:D008175', 'Disease') :: ['lung cancer'] @entity406 :: ('MESH:D005557', 'Chemical') :: ['formalin'] @entity9512 :: ('p|SUB|L|858|R', 'ProteinMutation') :: ['L858R'] @entity982 :: ('MESH:D010232', 'Chemical') :: ['paraffin'] @entity9513 :: ('p|SUB|T|790|M', 'ProteinMutation') :: ['T790M'] @entity2220 :: ('MESH:C538231', 'Disease') :: ['lung adenocarcinoma']
@entity2 :: (MESH:D008175,Disease) :: ['lung cancer']
