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Multicenter clinical experience with the Afirma gene expression classifier.

Erik K Alexander¹, Melanie Schorr, Joshua Klopper

¹Department of Medicine (E.K.A., M.S.), The Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts 02115; Department of Medicine (C.K., S.J.M.), Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104; Department of Medicine (J.S., F.N.), The Ohio State University College of Medicine, Columbus, Ohio 43210; University of Cincinnati College of Medicine (C.P., D.L.S.), Cincinnati, Ohio 45220; and Department of Medicine (J.K., B.R.H.), University of Colorado School of Medicine, Aurora, Colorado 80045.

The Journal of Clinical Endocrinology and Metabolism

|October 25, 2013

Summary

This summary is machine-generated.

The Afirma gene expression classifier (GEC) significantly impacts clinical decisions for indeterminate thyroid nodules, confirming its utility in patient care. Long-term, multisite analysis shows consistent performance, though minor site variations exist.

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Area of Science:

Endocrinology
Oncology
Molecular Diagnostics

Background:

Thyroid nodules with indeterminate cytology (AUS/FLUS, FN) often require further diagnostic testing.
The Afirma gene expression classifier (GEC) is increasingly used for these indeterminate thyroid nodules.
Limited long-term, multisite data exist on the Afirma GEC's real-world performance.

Purpose of the Study:

To evaluate the long-term, multisite performance of the Afirma GEC in indeterminate thyroid nodules.
To assess the impact of Afirma GEC results on clinical management and surgical recommendations.
To identify any site-to-site variations in Afirma GEC performance.

Main Methods:

Retrospective analysis of 339 patients undergoing Afirma GEC testing across five academic medical centers (2010-2013).
Data collected included nodule/patient characteristics, cytology, GEC results, and clinical/surgical follow-up.
Analysis focused on pooled test performance, impact on care, and inter-site variability.

Main Results:

Of 339 indeterminate nodules, 51% were GEC benign and 44% were GEC suspicious.
GEC results significantly altered management recommendations (P<.01), with surgery rates differing between benign and suspicious GEC results.
Of surgically removed nodules with indeterminate cytology/GEC suspicious results, 44% were malignant. Follow-up of GEC benign nodules showed a low cancer rate (1/71).

Conclusions:

Multicenter data confirm the Afirma GEC's performance and significant impact on clinical care recommendations for indeterminate thyroid nodules.
While some site-to-site variation in GEC performance was observed, it was not statistically significant.
Clinical follow-up of GEC benign nodules supports the diagnostic utility of the Afirma GEC test.