👉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% to 5% of allele frequency.
👉The results of this study show that ThyroSeq Genomic Classifier achieved high performance in adequately cellular routine cytology.
👉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.
👉The ThyroSeq test can help avoid costly diagnostic thyroid surgeries by reliably distinguishing between benign and cancerous thyroid nodules.
👉When a dedicated sample is not collected for molecular testing, cytology smears may be the only specimens available.
👉Expansion of ThyroSeq testing to cytology smears means that patients with indeterminate cytology will not have to come back into a physician’s office to have another sample taken, instead the available smears can be sent for testing.
👉Previously validated and acceptable specimen types for ThyroSeq include fresh FNA samples collected into ThyroSeqPreserve solution, which remains the gold standard of specimen quality, cytology cell blocks, and FFPE tissue.
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