title: Clinical diagnostic gene expression thyroid testing.
abstract: Thyroid fine-needle aspiration biopsies are cytologically indeterminate in 15% to 30% of cases. When cytologically indeterminate thyroid nodules undergo diagnostic surgery, approximately three-quarters prove to be histologically benign. A negative predictive value of more than or equal to 94% for the Afirma Gene Expression Classifier (GEC) is achieved for indeterminate nodules. Most Afirma GEC benign nodules can be clinically observed, as suggested by the National Comprehensive Cancer Network Thyroid Carcinoma Guideline. More than half of the benign nodules with indeterminate cytology (Bethesda categories III/IV) can be identified as GEC benign and removed from the surgical pool to prevent unnecessary diagnostic surgery.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267-0528, USA; Division of Endocrinology, Department of Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267-0528, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: Steward
authors.affiliation: Department of Medical Affairs, Veracyte, Inc, 7000 Shoreline Court, Suite 250, South San Francisco, CA 94080, USA. Electronic address: Richard.Kloos@veracyte.com.
authors.forename: Richard T
authors.initials: RT
authors.lastname: Kloos
mesh_terms: D044963:Biopsy, Fine-Needle; D003581:Cytodiagnosis / Q000379:methods; D004252:DNA Mutational Analysis; D020869:Gene Expression Profiling / Q000145:classification / Q000379:methods*; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D007150:Immunohistochemistry; D012680:Sensitivity and Specificity; D013961:Thyroid Gland / Q000473:pathology; D016606:Thyroid Nodule / Q000175:diagnosis* / Q000235:genetics* / Q000473:pathology; D013965:Thyroidectomy / Q000191:economics
keywords: Biopsy; DNA mutational analysis; Fine-needle aspirate; Gene expression; Genomics; Molecular diagnostic techniques; Thyroid nodule