Data Presented at the 2019 American Association of Clinical Endocrinologists Annual Meeting Demonstrate Performance of ThyroSeq Test in Cytology Smears
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".
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.
These results were presented in the oral presentation "Performance of ThyroSeq v3 Genomic Classifier in Fixed Cytology Smears" on Saturday, April 27, 2019 at 10:30-10:45 am during the meeting.
About Sonic Healthcare USA
Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.
About CBLPath, Inc.
CBLPath, a Sonic Healthcare Company, is a leading provider of sub-specialized anatomic pathology and molecular diagnostic laboratory services. In addition, CBLPath is a Center of Excellence in the interpretation of fine needle aspiration (FNA) of thyroid nodules having a staff of expert cytopathologists dedicated to the interpretation of over 40,000 thyroid FNAs annually. For more information, please visit www.cblpath.com.
About ThyroSeq
ThyroSeq® Genomic Classifier is an innovative test for thyroid nodules and cancer that utilizes next-generation sequencing technology and a proprietary genomic classifier to analyze 5 classes of alterations in DNA and RNA collected from a thyroid nodule, with reported results empowering physicians to individualize patient management. With more than a 10-year history of continuous refinement, it incorporates all major scientific discoveries and technological advances to provide the most accurate diagnosis of benign or malignant disease in thyroid nodules.
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