Six-Year Clinical and Imaging Follow Up of an Office-Based Gene Expression Classifier Used to Manage Thyroid Nodules


Interview with Brian Michael, M.D., Wellspan Health Gettysburg Hospital and Wellspan York Hospital

Dr. Brian Michael is an endocrinologist at Wellspan Health Gettysburg Hospital and Wellspan York Hospital. Dr. Michael began using the Afirma® Gene Expression Classifier (GEC) six years ago to help resolve indeterminate thyroid nodules and reduce the number of patients who undergo unnecessary surgery to obtain a nodule diagnosis. Dr. Michael has partnered with several other thought leading physicians over the past several years to assess the value of the classifier in real-world clinical practice. Most recently, he conducted a six-year analysis of outcomes among his patients whose thyroid nodules were classified as benign by the Afirma test.

Q: Why did you feel it was important to conduct this longer-term follow-up analysis of your Afirma GEC benign patients?

Dr. Michael: My primary objective in using the Afirma GEC – and conducting this research – is to help reduce the number of patients who will go to thyroid surgery because their thyroid nodule is classified as indeterminate following standard cytopathology. We perform very standardized follow up with our thyroid nodule patients and they tend to stay local, so we had the opportunity to conduct a longer-term evaluation of real-world Afirma outcomes.

Q In a nutshell, what did you find?

Dr. Michael: I looked at the patients in my practice who had indeterminate Bethesda III and IV nodules and were classified as benign with the Afirma test. We determined that we were able to significantly and safely decrease the number of patients going to surgery to resolve indeterminate nodules. Specifically, nearly 40 percent of our patients who would have gone to surgery using the old Bethesda criteria never went, and are being successfully followed six years later with stable physical and ultrasound findings.

Additionally, using standard Medicare reimbursement rates, I calculated that the reduction in surgeries enabled us to save the healthcare system a significant amount of money. Not to mention the potential comorbidities of surgery, the long-term impact of patients living without a thyroid, etc.

Even though the population I looked at was relatively small, I think these findings are still significant and useful for practicing physicians.

Q: As a physician who treats patients with thyroid nodules, why are these findings important and/or useful for you? What do they mean for your day-to-day practice?

Dr. Michael: These findings increase my comfort level with the Afirma GEC test, and it should increase other practitioners’ comfort levels as well. Of course, we still have to watch the patients that Afirma classifies as benign, but this evaluation contributes to mounting evidence that avoiding surgery up front and conducting standard follow-up for these patients is a safe approach.

Q. What should be the takeaway for your peers?

Dr. Michael: Using the Afirma test as prescribed in a non-academic, real-world situation can enable us to reduce the number of patients going to surgery unnecessarily while saving significant dollars for the healthcare system.