Afirma ResourcesTools for Learning and ComplianceUtilize the following resources in your assessment and use of Afirma Thyroid FNA Analysis:Physician Resources MSDS Afirma Overview for Patients (English) (PDF) Afirma Overview for Patients (Spanish) Resumen de Afirma Para Paciente (PDF) Veracyte Laboratory LicensesCLIA: 05D2014120 Afirma Thyroid FNA Analysis DescriptionThe Afirma Thyroid FNA Analysis is a diagnostic service provided by Veracyte, Inc. for the assessment of thyroid nodules. Patient samples obtained through fine needle aspirate (FNA) biopsies are collected for both cytopathology assessment and the Gene Expression Classifier. Initially, cytopathology assessment is conducted. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or nondiagnostic, the Afirma Thyroid FNA Analysis is complete. If the cytopathology diagnosis is indeterminate (includes Follicular Lesion of Undetermined Significance (FLUS)/Atypia of Undetermined Significance (AUS) and (suspicious for) Hürthle/Follicular Neoplasm), the thyroid nodule is greater than or equal to 1 cm and the patient is 21 years or older, the Gene Expression Classifier is performed. The Gene Expression Classifier determines the expression profile of RNA isolated from the nodule to be benign or suspicious for malignancy. Clinical correlation of the Afirma Thyroid FNA Analysis result is recommended. The Afirma Gene Expression Classifier and its performance characteristics were determined by Veracyte. Afirma Thyroid FNA Analysis is used for clinical purposes.The Veracyte laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The Veracyte laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. |
