Idylla ThyroidPrint® Assay
TP0011/6
Idylla™ ThyroidPrint® Assay, developed by GeneproDX, assesses the gene expression profile of Fine Needle Aspiration (FNA) samples to enable laboratories to conduct further research on risk stratification of indeterminate thyroid nodules.
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*Bethesda III and IV (International)/Thy3a and Thy3f (UK)/TIR3A and TIR 3B (Italian)
For Research Use Only (RUO), not for use in diagnostic procedures, developed by GeneproDX and distributed by Biocartis.
For more information on the SuperScript III license, click here.
| LDT1 | Idylla™2 | |
| Sensitivity | 91% | 92% |
| Specificity | 88% | 83% |
| NPV | 95% | 97% |
| PPV | 78% | 68% |
LDT = Laboratory Developed Test
Zafereo, M. et al. (2020). A Thyroid Genetic Classifier Correctly Predicts Benign Nodules with Indeterminate Cytology: Two Independent, Multicenter, Prospective Validation Trials. Thyroid : official journal of the American Thyroid Association, 30(5), 704–712. https://doi.org/10.1089/thy.2019.0490
González, H. E. et al. (2024). New sample-to-result Idylla™ ThyroidPrint® Assay accurately identifies benign thyroid nodules with indeterminate cytology: A multicenter-prospective double-blinded clinical validation trial. 46th Annual meeting of the European Thyroid Association. ETA 2024.
The high sensitivity and specificity in combination with the ease of use and short turnaround time make the Idylla™ ThyroidPrint® Assay first-in-class for risk stratification of indeterminate thyroid nodules.
SPECIMEN REQUIREMENTS
FNA from an indeterminate thyroid nodule collected in ThyroidPrint® Collection Buffer.
A NEW GENE SIGNATURE
The Idylla™ ThyroidPrint® Assay is a novel RT-qPCR-based molecular signature that assesses a gene expression profile from a fresh FNA sample collected from an indeterminate thyroid nodule. The signature qPCR data is analyzed by a proprietary algorithm, which reports a classifier result based on expression levels of a combination of 10 epithelial and stromal cell target genes relative to two reference genes1.
González, H. E. et al. (2017). A 10-Gene Classifier for Indeterminate Thyroid Nodules: Development and Multicenter Accuracy Study. Thyroid: official journal of the American Thyroid Association, 27(8), 1058–1067. https://doi.org/10.1089/thy.2017.0067
Zafereo, M. et al. (2020). A Thyroid Genetic Classifier Correctly Predicts Benign Nodules with Indeterminate Cytology: Two Independent, Multicenter, Prospective Validation Trials. Thyroid: official journal of the American Thyroid Association, 30(5), 704–712. https://doi.org/10.1089/thy.2019.0490
Olmos, R. et al. (2023). ThyroidPrint®: clinical utility for indeterminate thyroid cytology. Endocrine-related cancer, 30(11), e220409. https://doi.org/10.1530/ ERC-22-0409
Fully Automated Sample-to-result Reporting on Idylla Platform
Idylla™ ThyroidPrint® Assay covers the entire process from sample to result, including fully integrated sample preparation, nucleic acid extraction, reverse transcription of RNA, real-time PCR amplification and detection and, data analysis, and result reporting as applicable. An automated console report will be generated with either a 'HIGH' or 'LOW' result.
A 'HIGH' result is indicative of an atypical gene expression. While a 'LOW' result is indicative of a normal gene expression.
