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Veracyte : Data From Multiple Studies Show Value Of Afirma Genomic Sequencing

Veracyte Inc. (VCYT) said that early user-experience data from three independent studies demonstrate that the next-generation Afirma Genomic Sequencing Classifier (GSC) significantly increases the number of patients who can avoid unnecessary surgery in thyroid cancer diagnosis, compared to the original, market-leading Afirma Gene Expression Classifier.

In each study, researchers found that the Afirma GSC identified significantly more benign thyroid nodules among those deemed indeterminate - not clearly benign or malignant - by cytopathology review, compared to the first-generation test. Each institution began using the next-generation test shortly after it was introduced in July 2017 and, prior to that, had used the original Afirma test for several years.

Researchers from The Ohio State University found that among 47 indeterminate cases that underwent Afirma GSC testing, the next-generation test identified nearly three fourths (72.3 percent) of the patients as benign. This was significantly higher than the nearly half (48.4 percent) that were identified as benign by GEC testing from 2011 thorough mid-2017.

In a separate presentation, R. Mack Harrell, M.D., of the Memorial Center for Integrative Endocrine Surgery in Boca Raton, Fla., showed that at his institution the Afirma GSC identified approximately 51 percent more indeterminate nodules as benign, compared to the first-generation Afirma test. Among the particularly challenging sub-set of thyroid nodules known as Hürthle-cell dominant, use of the next-generation test resulted in a 49 percent increase in the percentage of nodules classified as benign.

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