Analytic performance studies and clinical reproducibility of a real-time PCR assay for the detection of epidermal growth factor receptor gene mutations in formalin-fixed paraffin-embedded tissue specimens of non-small cell lung cancer

BMC Cancer

Volumn 13, Issue , 2013, Pages

  O'Donnell, Patrick ^a   Ferguson, Jane ^a   Shyu, Johnny ^a   Current, Robert ^a   Rehage, Taraneh ^a   Tsai, Julie ^a   Christensen, Mari ^a   Tran, Ha Bich ^a   Chien, Sean Shih Chang ^a   Shieh, Felice ^a   Wei, Wen ^a   Lawrence, H Jeffrey ^a   Wu, Lin ^a   Schilling, Robert ^a   Bloom, Kenneth ^b   Maltzman, Warren ^c   Anderson, Steven ^d   Soviero, Stephen ^a  

^a ROCHE MOLECULAR SYSTEMS   (United States)

^b Clarient Inc   (United States)

^c IQVIA   (United States)

^d LABORATORY CORPORATION OF AMERICA   (United States)

Author keywords

Analytical validation; Companion diagnostics; EGFR mutation testing; Molecular diagnostics; Non small cell lung cancer; Reproducibility

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; PLASMID DNA;

ACCURACY; ANALYTICAL EQUIPMENT; ARTICLE; CANCER TISSUE; CONTROLLED STUDY; DNA SEQUENCE; EPIDERMAL GROWTH FACTOR RECEPTOR GENE; EXON; FORMALIN FIXED PARAFFIN EMBEDDED TISSUE; GENE DELETION; GENE MUTATION; GENETIC PROCEDURES; HUMAN; HUMAN TISSUE; LIMIT OF DETECTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MASSIVELY PARALLEL PYROSEQUENCING; MULTIPLEX POLYMERASE CHAIN REACTION; MUTATIONAL ANALYSIS; PHARMACOGENETICS; REAL TIME POLYMERASE CHAIN REACTION; REPRODUCIBILITY; SANGER SEQUENCING; SENSITIVITY ANALYSIS; SEQUENCE HOMOLOGY; TISSUE PREPARATION; TUMOR NECROSIS; VALIDATION PROCESS;

CARCINOMA, NON-SMALL-CELL LUNG; DNA MUTATIONAL ANALYSIS; EXONS; HUMANS; LIMIT OF DETECTION; LUNG NEOPLASMS; MOLECULAR DIAGNOSTIC TECHNIQUES; MULTIPLEX POLYMERASE CHAIN REACTION; MUTATION; PARAFFIN EMBEDDING; REAL-TIME POLYMERASE CHAIN REACTION; RECEPTOR, EPIDERMAL GROWTH FACTOR; REPRODUCIBILITY OF RESULTS;

EID: 84876695102     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-13-210     Document Type: Article

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