Real-World Performance of the Afirma Genomic Sequencing Classifier (GSC)-A Meta-analysis.

Autor:	Nasr CE; University of Arizona College of Medicine Phoenix, Phoenix, AZ 85004, USA., Andrioli M; Centro EndocrinologiaOggi, 00199 Roma, Italy., Endo M; Endocrine Care Center at University of Washington Medical Center, Seattle, WA 98105, USA., Harrell RM; Memorial Healthcare System, Hollywood, FL 33021, USA., Livhits MJ; Endocrine Center, UCLA, Los Angeles, CA 90095, USA., Osakwe I; Division of Endocrinology, Umass Chan Medical School, Baystate, Springfield, MA 01199, USA., Polavarapu P; University of Nebraska Medical Center, Omaha, NE 68198, USA., Siperstein A; Department of Endocrine Surgery, Cleveland Clinic, Cleveland, OH 44195, USA., Wei S; Fox Chase Cancer Center, Philadelphia, PA 19111, USA., Zheng X; Veracyte, Inc., South San Francisco, CA 94080, USA., Jiang R; Veracyte, Inc., South San Francisco, CA 94080, USA., Hao Y; Veracyte, Inc., South San Francisco, CA 94080, USA., Huang JIN; Veracyte, Inc., South San Francisco, CA 94080, USA., Klopper JP; Veracyte, Inc., South San Francisco, CA 94080, USA., Kloos RT; Veracyte, Inc., South San Francisco, CA 94080, USA., Kennedy G; Veracyte, Inc., South San Francisco, CA 94080, USA., Angell TE; Thyroid Center, Keck School of Medicine of USC, Los Angeles, CA 90033, USA.
Jazyk:	angličtina
Zdroj:	The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2023 May 17; Vol. 108 (6), pp. 1526-1532.
DOI:	10.1210/clinem/dgac688
Abstrakt:	Context: The Afirma® GSC aids in risk stratifying indeterminate thyroid nodule cytology (ITN). The 2018 GSC validation study (VS) reported a sensitivity (SN) of 91%, specificity (SP) of 68%, positive predictive value (PPV) of 47%, and negative predictive value (NPV) of 96%. Since then, 13 independent real-world (RW) postvalidation studies have been published. Objective: This study's objective is to compare the RW GSC performance to the VS metrics. Methods: Rules and assumptions applying to this analysis include: (1) At least 1 patient with molecular benign results must have surgery for that study to be included in SN, SP, and NPV analyses. (2) Molecular benign results without surgical histology are considered true negatives (TN) (as are molecular benign results with benign surgical histology). (3) Unoperated patients with suspicious results are either excluded from analysis (observed PPV [oPPV] and observed SP [oSP]) or assumed histology negatives (false positives; conservative PPV [cPPV] and conservative SP [cSP]) 4. Noninvasive follicular thyroid neoplasm with papillary-like nuclear features is considered malignant. Results: In RW studies, the GSC demonstrates a SN, oSP, oPPV, and NPV of 97%, 88%, 65%, 99% respectively, and conservative RW performance showed cSP of 80% and cPPV of 49%, all significantly higher than the VS except for SN and cPPV. There was also a higher benign call rate (BCR) of 67% in RW studies compared to 54% in the VS (P < 0.05). Conclusion: RW data for the Afirma GSC demonstrates significantly better oSP and oPPV performance than the VS, indicating an increased yield of cancers for resected GSC suspicious nodules. The higher BCR likely increases the overall rate of clinical observation in lieu of surgery. (© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu