Overview

The Afirma Thyroid FNA Analysis provides a novel solution for improved thyroid nodule assessment. This advanced offering combines specialized cytopathology with the Afirma Genomic Sequencing Classifier (GSC) for the management of patients with thyroid nodules. As the largest thyroid-specialized cytopathology practice, TCP provides clear and confident cytopathology results. In the 14-17% of thyroid nodules that TCP identifies as indeterminate1, the Afirma GSC reclassifies them as either benign or suspicious for cancer. By helping physicians pre-operatively identify benign nodules (negative predictive value 96%) in patients with indeterminate* cytopathology, the Afirma solution may enable clinical and sonographic follow-up for these patients in lieu of diagnostic surgery.2,3,4 Similar to cytologically benign nodules, the risk of malignancy is reduced to 4% with a GSC benign result.4

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* Indeterminate (Bethesda III/IV) includes atypia of undermined significance or follicular lesion of undermined significance (AUS/FLUS) and follicular neoplasm or suspicious for a follicular neoplasm (FN/SFN).

1. Data on file at Thyroid Cytopathology Partners. 2018.
2. Duick DS, Klopper JP, Diggans JC, Friedman L, Kennedy GC, Lanman RB, et al. The impact of benign gene expression classifier test results on the endocrinology decision-to-operate in patients with thyroid nodules with indeterminate FNA cytopathology. Thyroid. Published Online July 12, 2012.
3. Alexander, EK,. Schorr, M, Klopper, J, Kim, C, Sipos, J, Nabhan, F, Parker, C, Steward, DL, Mandel, SJ, Haugen, BR. Multi-center clinical experience with the Afirma Gene Expression Classifier. J Clin Endocrinol Metab. E-publication ahead of print October 23, 2013.
4. Patel, JAMA Surgery, 2018.
5. Wang CC, Friedman L, Kennedy GC, Wang H, Kebebew E, Steward DL, et al. A Large Multicenter Correlation Study of Thyroid Nodule Cytopathology and Histopathology. Thyroid. 2011;21:243-251.
6. Gharib H, Papini E, Paschke R, Duick DS, Valcavi R, Hegedüs L, et al. American Association of Clinical Endocrinologists, Associazione Medicie Endocrinologi, and European Thyroid Association medical guidelines for clinical practice for the diagnosis and management of thyroid nodules: executive summary of recommendations. Endocr Pract. 2010;16(S1):1-43.
7. Cooper DS, Doherty GM, Haugen BR, Kloos RT, Lee SL, Mandel SJ, et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid.2009;19:1167-1214.
8. Jameson JL. Minimizing Unnecessary Surgery for Thyroid Nodules. N Engl J Med. 2012; 367:765-767.