Afirma Genomic Sequencing Classifier Experience among the First 5478 Consecutive Samples from Cytologically Indeterminate Thyroid Nodules


Interview with Michael H. Shanik, M.D., F.A.C.P, F.A.C.E

Dr. Michael Shanik is an endocrinologist at Endocrine Associates of Long Island who specializes in treating endocrine and metabolic disorders. Dr. Shanik served as an investigator for the Afirma® Gene Expression Classifier (GEC) and was an early adopter of the test. Most recently, he participated in an evaluation of clinical experiences and results from the next-generation Afirma® Genomic Sequencing Classifier (GSC). Dr. Shanik presented findings from this analysis at the ENDO 2018 meeting on March 17.

Q: What was the intention of this analysis?

Dr. Shanik: The purpose was to report on initial real-world experience with the Afirma GSC since its introduction in July 2017. We analyzed results of consecutive GSC samples and compared them to the GEC real-world results.

Q: Topline, what did you find? And how do these findings compare with those of the Afirma GSC clinical validation study results that were presented at the AACE annual meeting last May?

Dr. Shanik: Among all of the Afirma GSC samples received, 64% were benign and 36% were suspicious. This represents a higher proportion of benign results as compared to the experience with the Afirma GEC. These new findings are similar to the Afirma GSC clinical validation study results reported at the AACE 2017 Annual Meeting, which suggested that by further improving the Afirma GEC’s specificity, the Afirma GSC identified significantly more benign thyroid nodules among those deemed indeterminate following cytopathology.

Q: What level of confidence do you have that the additional benign calls generated by the Afirma GSC are, indeed, benign?

Dr. Shanik: The additional benign calls generated by the Afirma GSC represent a significantly higher proportion of patients who likely will be monitored without referral for surgery. The previously reported clinical validation results – which were generated from a prospective, multicenter, blinded cohort study with a large sample (191 indeterminate nodules) – give me tremendous confidence that these GSC benign calls are reliable.

Q: What do these results mean for you and your patients at a very practical level?

Dr. Shanik:: On a practical level, patients with indeterminate cytology can feel assured that additional testing is available, which in many cases will negate the need for them to be subjected to unnecessary diagnostic surgeries. In addition, samples for cytology and the Afirma GSC are collected simultaneously at the time of the fine-needle aspiration (FNA), and this streamlines the process for physicians and patients.

Q: What would you like your peers to take away from the Afirma GSC poster you presented at ENDO this year?

Dr. Shanik: A significant proportion of patients who undergo an FNA will have indeterminate cytology, but we’ve come a long way from when we had to refer most of them for diagnostic surgery. Since its introduction in 2011, the Afirma GEC has helped spare more than 40,000 patients from unnecessary surgery. The Afirma GSC results we’ve seen to date – including the findings I reported at ENDO this year – demonstrate that RNA sequencing and advanced machine learning techniques harness new genomic information that leads to the majority of patients receiving a benign result and, typically, less invasive clinical observation. For the minority of patients who receive a suspicious result, which denotes a nearly 50 percent chance of having thyroid cancer, the Afirma GSC provides stronger evidence for the patient and the treating physician to take the next step toward surgery.

Read the Abstract Here