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Comment & Response |

Gene Expression Classifier Testing and the Surgical Decision-Making Process for Patients With Thyroid Nodules—Reply

Salem I. Noureldine, MD1; Martha A. Zeiger, MD2; Ralph P. Tufano, MD, MBA1
[+] Author Affiliations
1Division of Head and Neck Endocrine Surgery, Department of Otolaryngology–Head and Neck Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland
2Endocrine Surgery, Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland
JAMA Otolaryngol Head Neck Surg. 2016;142(8):807. doi:10.1001/jamaoto.2016.0515.
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In Reply Drs Kloos and Barth,1 employees and equity owners of Veracyte raise questions about the design and findings of our study examining the effect of Veracyte’s Afirma gene expression classifier (GEC) on the practice of 10 thyroid surgeons at an academic institution.2

Our study evaluated patients who underwent GEC testing of a thyroid nodule prior to being referred for surgical consultation. In most patients, the GEC was not used for its intended purpose, namely as a negative predictor of malignant disease or to help direct patients to watchful waiting in lieu of surgery. These patients were already surgical candidates for myriad reasons detailed in our article and watchful waiting was not applicable, even if the GEC was negative. Furthermore, the Afirma GEC was frequently misinterpreted when positive (suspicious) by the referring endocrinologists, and even among our own surgeons, leading to overtreatment.

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August 1, 2016
Richard T. Kloos, MD; Neil M. Barth, MD
1Veracyte, Inc, South San Francisco, California
JAMA Otolaryngol Head Neck Surg. 2016;142(8):806-807. doi:10.1001/jamaoto.2016.0200.
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