Idylla ThyroidPrint® Assay
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.
| LDT | Idylla™ | |
| Sensitivity | 91% | 92% |
| Specificity | 88% | 82% |
| NPV | 95% | 96% |
| PPV | 78% | 66% |
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.
ThyroidPrint® LDT (Laboratory Developed Test) results from Zafereo et al., Thyroid 2020.
Idylla™ ThyroidPrint® Assay results from unpublished data (internal analysis based on 132 indeterminate samples compared to the surgical gold standard)
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 .
- 1Zafereo et al., Thyroid, 2020
Gonzalez et al. Thyroid, 2017
Olmos et al. Endorine-Related Cancer 2023
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.
*Bethesda III and IV (International)/Thy3a and Thy3f (UK)/TIR3A and TIR 3B (Italian)
Idylla™ ThyroidPrint® Assay is for Research Use Only (RUO), not for use in diagnostic procedures. The Idylla™ ThyroidPrint® Assay contains SuperScript™ III Reverse Transcriptase and is provided subject to a license under patents or patent applications owned by or licensed to Life Technologies Corporation, which license is limited to the human diagnostic field and research field and specifically excludes applications in forensics (including human identity testing). The SuperScript™ III trademark is owned by Life Technologies Corporation. For more information, click here.