New Study Validates Cytology Smears as an Alternative Sample Type for ThyroSeq Testing
Austin, TX – July 22, 2020
A new validation study published today, “Thyroid Cytology Smear Slides: An Untapped Resource for ThyroSeq Testing”, provided extensive validation of cytology smears as an acceptable alternative for ThyroSeq® GC testing in patients with indeterminate thyroid cytology. The study was performed at UPMC and the University of Pennsylvania and reported in Cancer Cytopathology.
ThyroSeq, commercially available through Sonic Healthcare USA and their network of clinical laboratories and pathology practices throughout the United States, is a comprehensive molecular test for thyroid nodules and cancer that is typically performed using a sample collected during a fine needle aspiration (FNA) procedure.
In this study, ThyroSeq performance was assessed in routinely prepared air-dried Diff-Quik® and alcohol-fixed Papanicolaou stained cytology smears and compared to the test results obtained using freshly collected FNA samples from the same nodules.
The study showed that more than 80% of routinely prepared cytology smears, including all alcohol-fixed Papanicolaou stained smears, could be successfully used for ThyroSeq testing to assess multiple types of genetic markers and provide accurate test results in thyroid nodules with indeterminate cytology.
“The results of this two-institutional study expand the range of acceptable sample types for ThyroSeq Genomic Classifier,” said Marina Nikiforova, MD, Professor of Pathology and Director of Molecular and Genomic Pathology Laboratory at University of Pittsburgh Medical Center, and lead author of the study. “This will enable more patients to benefit from ThyroSeq testing, save expenses associated with a second office visit and repeated FNA biopsy, while offering high diagnostic accuracy needed to improve 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 at the time of FNA procedure, 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 formalinfixed and paraffin-embedded tissue. This study demonstrates that ThyroSeq can be performed using routine cytology smears, while maintaining the robust diagnostic accuracy.
Link to validation study can be found here: Cancer Cytopathology
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 over 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.
ThyroSeq® Genomic Classifier is an innovative test for thyroid nodules and cancer that utilizes next-generation sequencing technology to analysis both DNA and RNA collected from a thyroid nodule to generate comprehensive genomic profiling of cells and uses a proprietary genomic classifier, to provide comprehensive diagnostic and prognostic information on the nodule, 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 offer the most accurate diagnosis of benign or malignant disease in thyroid nodules.
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