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Evaluation of the Afirma Gene Expression Classifier in Repeat Indeterminate Thyroid Nodules
Grant Harrison, Julie Ann Sosa, Xiaoyin Jiang1
1From the Department of Pathology (Drs Harrison and Jiang) and the Section of Endocrine Surgery (Dr Sosa), Duke University Medical Center, Durham, North Carolina.
Archives of Pathology & Laboratory Medicine
|May 4, 2017
Summary
The Afirma Gene Expression Classifier identified 50% of indeterminate thyroid nodules as suspicious, with a 35% malignancy rate in surgical cases. This molecular test shows a low positive predictive value for thyroid nodules.
Area of Science:
- Endocrinology
- Oncology
- Molecular Diagnostics
Background:
- Molecular testing for indeterminate thyroid nodules is evolving.
- Outcomes for these tests vary.
- Repeat fine-needle aspirations are used for diagnosis.
Purpose of the Study:
- To evaluate the Afirma Gene Expression Classifier's performance.
- To analyze repeat fine-needle aspirations in indeterminate thyroid nodules.
- To report experience from a tertiary thyroid referral center.
Main Methods:
- Collected cytopathology and Afirma test results from August 2013 to March 2015.
- Included nodules with previous indeterminate cytologic results.
- Correlated Afirma results with surgical resection diagnoses when available.
Main Results:
- 115 nodules were tested; 87% were Bethesda III or IV.
- Afirma classified 45% as benign and 50% as suspicious.
- Of suspicious nodules, 35% were malignant upon resection (positive predictive value 35%).
Conclusions:
- Afirma classified 50% of indeterminate nodules as suspicious.
- Malignancy rate in suspicious nodules was 35%, higher than historical rates.
- The Afirma test demonstrated a low positive predictive value in this cohort.
