Clinical investigational studies for validation of a next-generation sequencing in vitro diagnostic device for cystic fibrosis testing

Expert Review of Molecular Diagnostics

Volumn 14, Issue 5, 2014, Pages 605-622

  Grosu, Daniel S ^a   Hague, Lynda ^a   Chelliserry, Manjula ^a   Kruglyak, Kristina M ^a   Lenta, Ross ^a   Klotzle, Brandy ^a   San, Jonathan ^a   Goldstein, Wendy M ^a   Moturi, Sharmili ^a   Devers, Patricia ^a   Woolworth, Julie ^b   Peters, Eric ^a   Elashoff, Barbara ^c   Stoerker, Jay ^d   Wolff, Daynna J ^b   Friedman, Kenneth J ^e   Highsmith, W Edward ^f   Lin, Erick ^a   Ong, Frank S ^a  

^a ILLUMINA INC   (United States)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c Myraqa Inc   (United States)

^d Progenity Inc   (United States)

^e LABORATORY CORPORATION OF AMERICA   (United States)

^f Mayo Clinic   (United States)

Author keywords

Clinical validation; Cystic fibrosis; In vitro diagnostics; Next generation sequencing; Sequencing by synthesis

Indexed keywords

CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR;

139 VARIANT ASSAY; ARTICLE; ASSAY; CLINICAL SEQUENCING ASSAY; CONTROLLED STUDY; CYSTIC FIBROSIS; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; DIGESTIVE DIAGNOSTIC DEVICE; GENETIC PROCEDURES; HUMAN; HUMAN CELL; IN VITRO STUDY; MISEQDX CYSTIC FIBROSIS SYSTEM; NEXT GENERATION SEQUENCING; REPRODUCIBILITY; VALIDATION STUDY; DNA SEQUENCE; GENETICS; HIGH THROUGHPUT SEQUENCING; MOLECULAR DIAGNOSIS; PROCEDURES; SENSITIVITY AND SPECIFICITY; STANDARDS;

CYSTIC FIBROSIS; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; MOLECULAR DIAGNOSTIC TECHNIQUES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SEQUENCE ANALYSIS, DNA;

EID: 84901281950     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2014.916618     Document Type: Article

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