![]() ![]() Noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) is considered malignant as these lesions require surgical excision to make the diagnosis and they are not categorized histologically as benign. The purpose of this meta-analysis is to compare the postvalidation, RW performance of the Afirma GSC to the VS metrics. The primary value of the Afirma GSC is to identify molecular benign lesions in ITN and allow conservative clinical follow-up. However, that analysis, as well as other recent meta-analyses of the Afirma GSC ( 21, 22), combine the VS data and exclude unoperated molecular benign results, which is a methodological limitation to a real-world (RW) assessment of the test performance. A previously published meta-analysis by Vuong et al that included the Afirma GEC and GSC validation studies as well as 5 of the GSC postvalidation studies compared the respective performances and showed significantly improved performance of the Afirma GSC compared with the GEC ( 20). Since then, 13 independent, single-center institution experiences utilizing the Afirma GSC have been published ( 7–19). The results showed (at a 24% cancer prevalence): sensitivity (SN) of 91% (CI, 79%-98%), specificity (SP) of 68% (CI, 60%-76%), negative predictive value (NPV) of 96% (CI, 90%-99%), and positive predictive value (PPV) of 47% (CI, 36%-58%) ( 6). ![]() All patients underwent surgery without known genomic information and were assigned a histopathology diagnosis by an expert panel blinded to all genomic information. The 2018 GSC VS was based on a cohort of ITN samples collected prospectively from multiple community and academic centers for the Afirma Gene Expression Classifier (GEC) validation. In 2018, the validation study (VS) of the updated Afirma Genomic Sequencing Classifier (GSC) was published. ![]() Given an average risk of malignancy of approximately 25% in ITN, the Afirma® Gene Expression Classifier was developed as a molecular diagnostic test with a high negative predictive value (94% across BIII and BIV nodules) designed to reliably rule out thyroid cancer in ITN and avoid unnecessary surgery ( 5). The risk of malignancy of BIII and BIV ITN ranges from 6% to 40% depending on the institution and the categorization of noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) as benign or malignant ( 4). Approximately 20% to 25% of thyroid nodule aspirates result in indeterminate thyroid nodule (ITN) cytology, primarily in the Bethesda III (BIII) or IV (BIV) categories ( 3). Thyroid cancer almost always presents as a thyroid nodule, yet only 5% to 15% of thyroid nodules harbor thyroid malignancy ( 2). Thyroid cancer is the most common endocrine malignancy, with an estimated 43 800 expected new cases diagnosed in 2022 and representing the seventh most common cancer in women ( 1). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |