Performance of ThyroSeq Test in Cytology Smears

AUSTIN, Texas, April 29, 2019 /PRNewswire/ -- Validation of ThyroSeq® Genomic Classifier performance in an expanded range of sample types has been presented at the 28th Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) in Los Angeles, California. ThyroSeq, commercially offered by CBLPath, a Sonic Healthcare Company, is a comprehensive molecular test for thyroid nodules and cancer that is typically performed using a dedicated sample collected during fine needle aspiration (FNA) procedure. This study demonstrates that ThyroSeq can be performed using routine cytology smears, while maintaining the robust diagnostic accuracy.

In this study, ThyroSeq performance was assessed in routinely prepared Diff-Quik® and Papanicolaou-stained cytology smears. Adequate DNA results for mutations and copy number alterations were obtained in 93% of nodules and RNA results for gene fusions and gene expression in 79% of nodules. In addition, ThyroSeq performance was evaluated in reference cytology slides included in a worldwide ring trial study on quantitative cytological molecular reference specimens. ThyroSeq demonstrated accurate detection of all mutations down to 3-5% of allele frequency.

"The results of this study show that ThyroSeq Genomic Classifier achieved high performance in adequately cellular routine cytology smears," said Yuri Nikiforov, MD, PhD, Vice Chair of the Department of Pathology and Director of Molecular and Genomic Pathology at University of Pittsburgh Medical Center, who presented the study at the annual meeting. "The expansion of acceptable sample types will enable more patients to benefit from ThyroSeq testing, save expenses associated with another office visit and repeated FNA biopsy, while offering the same high diagnostic accuracy to optimize patient management".

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