New Multicenter Long-term Outcome Study Demonstrates Durable Afirma GEC Benign Results


A new multicenter study showed that 82.7% of Afirma GEC benign patients avoided surgery with a median follow-up of 26.4 months (range 0-44 months) across 16 community practices.


Methods: A retrospective, multicenter long-term follow-up study carried out by Jennifer A. Sipos MD from The Ohio State University and Julie Ann Sosa MD from Duke University School of Medicine. Practice data on 98 Afirma GEC benign nodules from 98 patients with a median follow-up of 26 months (range 0-44 months) were collected. The study evaluated:

  • Overall operative rate
  • Kaplan-Meier analysis to illustrate the outcome of surgical rate over time
  • Treating physician’s opinion regarding the safety of Afirma GEC vs. usual care

Results: Thyroidectomy was performed in 17 patients (17.3% operative rate). The Kaplan-Meier analysis demonstrated that the majority of surgeries (10/17, or 58.8%) occurred within the first year after obtaining the Afirma GEC benign result. Within 2 years, 88% of all surgeries were performed. Additionally, in 78 of 91 (86%) cases, the physicians that were surveyed reported patient safety was improved by using the Afirma GEC test compared to not using it. In 11 of 91 (12%) cases, the physician reported that using the Afirma GEC test had no impact on patient safety.

Figure 1: Each drop in the Kaplan-Meier curve above represents a patient surgery. The slope of the curve begins to flatten after year one and very few surgeries were performed after year 2.


Conclusion: “It appears that GEC testing is associated with a durable reduction in the rate of surgery that clinicians believe is safe when patients are followed for 36 months after a benign GEC result”[i]

“If the decision not to operate on nodules with GEC benign results is durable through three years of observation, broad conclusions regarding safety and durability of surveillance are unlikely to significantly change in studies of longer duration”[i]

The full article, published in Endocrine Practice, can be found at this link.


[i] Sipos JA, et al. Long-term Non-operative Rate of Thyroid Nodules with Benign Results on the Afirma Gene Expression Classifier. Endocrine Practice. 2016 Jan 20. [Epub ahead of print]