Michiya Nishino, Marina Nikiforova1. 1. From the Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts (Dr Nishino); and the Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania (Dr Nikiforova).
Abstract
CONTEXT: - Approximately 15% to 30% of thyroid nodules that undergo fine-needle aspiration are classified as cytologically indeterminate, presenting management challenges for patients and clinicians alike. During the past several years, several molecular tests have been developed to reduce the diagnostic uncertainty of indeterminate thyroid fine-needle aspirations. OBJECTIVE: - To review the methodology, clinical validation, and recent peer-reviewed literature for 4 molecular tests that are currently marketed for cytologically indeterminate thyroid fine-needle aspiration specimens: Afirma, ThyroSeq, ThyGenX/ThyraMIR, and RosettaGX Reveal. DATA SOURCES: - Peer-reviewed literature retrieved from PubMed search, data provided by company websites and representatives, and authors' personal experiences. CONCLUSIONS: - The 4 commercially available molecular tests for thyroid cytology offer unique approaches to improve the risk stratification of thyroid nodules. Familiarity with data from the validation studies as well as the emerging literature about test performance in the postvalidation setting can help users to select and interpret these tests in a clinically meaningful way.
CONTEXT: - Approximately 15% to 30% of thyroid nodules that undergo fine-needle aspiration are classified as cytologically indeterminate, presenting management challenges for patients and clinicians alike. During the past several years, several molecular tests have been developed to reduce the diagnostic uncertainty of indeterminate thyroid fine-needle aspirations. OBJECTIVE: - To review the methodology, clinical validation, and recent peer-reviewed literature for 4 molecular tests that are currently marketed for cytologically indeterminate thyroid fine-needle aspiration specimens: Afirma, ThyroSeq, ThyGenX/ThyraMIR, and RosettaGX Reveal. DATA SOURCES: - Peer-reviewed literature retrieved from PubMed search, data provided by company websites and representatives, and authors' personal experiences. CONCLUSIONS: - The 4 commercially available molecular tests for thyroid cytology offer unique approaches to improve the risk stratification of thyroid nodules. Familiarity with data from the validation studies as well as the emerging literature about test performance in the postvalidation setting can help users to select and interpret these tests in a clinically meaningful way.