In one study, researchers evaluated results of all Afirma GEC tests performed between
"These findings tell us that physicians are respecting the determination of the Afirma GEC and that, if the GEC result is benign, patients are avoiding surgery during long-term follow-up," said
In another study, researchers conducted a six-year analysis of outcomes at a single clinical practice for patients whose thyroid nodules were classified as benign by the Afirma GEC. They found that approximately 30 percent of their patients who would have historically gone to surgery because of indeterminate thyroid nodule fine needle aspiration (FNA) biopsy results were able to avoid the procedure. During up to six years of follow-up, all of these patients' nodules have shown no change by serial examination or sonography. The findings were presented by
Additionally, data on the development of
Separately, data from a pivotal clinical validation study were shared earlier during the AACE meeting. These data, conducted on a prospective, multicenter, blinded cohort, showed that the Afirma GSC maintained the current test's high sensitivity (91 percent vs. 90 percent) and significantly increased its specificity (68 percent vs. 52 percent). The Afirma GSC's negative predictive value was 96 percent, compared to 94 percent for the current test.
"The long-term clinical outcome data presented at the AACE meeting reinforce that our current Afirma test has become a new standard of care in thyroid cancer diagnosis," said
The Afirma Genomic Sequencing Classifier is the next-generation version of the Afirma Gene Expression Classifier, and is used to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to preserve the thyroid. Each year in
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