Performance of Afirma Genomic Sequencing Classifier: The Initial Cleveland Clinic Experience

Interview with Christian Nasr, M.D., Medical Director, Thyroid Center, Endocrinology & Metabolism Institute, Cleveland Clinic, Cleveland, OH

Dr. Christian Nasr is medical director of the Thyroid Center in the Endocrinology & Metabolism Institute at Cleveland Clinic in Cleveland, Ohio. Dr. Nasr and his colleagues’ practice began using the next-generation Afirma® Genomic Sequencing Classifier (GSC) for its thyroid nodule patients in July 2017 and had previously used the Afirma® Gene Expression Classifier (GEC) since December 2011.

Q: Can you explain the purpose of the study your team is presenting at the ATA meeting?

Dr. Nasr: Our goal was to compare our institution’s results with the Afirma GSC versus our previous experience with the GEC. Specifically, we wanted to see whether we were sending fewer patients with indeterminate thyroid nodules to surgery.

Q: How did you go about making this comparison?

Dr. Nasr: We conducted a chart review of all patients with indeterminate thyroid nodules who were tested with the GEC or GSC over a six-year period. We evaluated the rate of benign calls made with each test, as well as the rate of patients going to surgery and, in patients who underwent surgery after GSC or GEC testing, we compared the genomic testing results with those of surgical pathology.

Q: What were the key takeaways from your findings?

Dr. Nasr: We found that the rate of benign calls with the GSC was significantly higher than with the GEC and that the GSC had high sensitivity and a high negative predictive value, similar to the GEC. We also found that we sent significantly fewer patients to surgery following GSC testing. Additionally, of those patients who went to surgery, the malignancy rate was higher among those that the GSC had identified as “suspicious” for cancer.

Q: Why are these findings important for patient care?

Dr. Nasr: When you send fewer patients to surgery, you want to make sure you’re doing the right things – in other words, that the patient really doesn’t have cancer. Ultimately, sending fewer patients to surgery (that is not needed) is better for the patients. Even in the best of hands, there is a certain amount of risk of complications. So why do it if you can avoid it? Plus, there is cost savings – and patients are always happy when they know they can safely avoid surgery.

Q: What’s next in terms of your research with the Afirma GSC?

Dr. Nasr: It’s important to monitor the use of all technologies over time. To that end, we’ll continue to routinely monitor patients to be certain that benign cases truly are benign. We plan to publish our findings in order to share our knowledge with the medical community.