IDYLLATM POLE-POLD1 MUTATION ASSAY (RUO)
A0281/6
The Idylla™ POLE-POLD1 Mutation Assay provides a rapid and reliable solution to close an important gap in oncology research by enabling molecular classification of endometrial cancer samples.
- Fully automated solution to detect 99% of the known pathogenic POLE and POLD1 mutations
- Demonstrated 98.6% accuracy with 434 endometrial cancer tissue samples
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For Research Use Only (RUO), not for use in diagnostic procedures.
*For samples with ≥ 10% neoplastic cells and ≥ 25 mm² x 10 µm tissue area
Specimen requirements
- 1x 5 μm FFPE tissue section: 50-600 mm²
- 1x 10 μm FFPE tissue section: 25-300 mm²
- Neoplastic cells ≥10% - if less, macrodissection is required
A retrospective, multi-center study was conducted to evaluate the Assay’s potential by comparing it to NGS, Sanger of qPCR using a cohort of endometrial cancer samples1, 2.
1: MSKCC (USA), 2: Compunet (USA); 3: CMOCO (USA); 4: Methodist (USA); 5: Augusta (USA); 6: Hvidovre (DK); 7: Arnau de Vilanova (ES); 8: Ludwigsburg (DE); 9: Kassel (DE); 10: Graz (AT)
The Assay used during this prototype study included 12 POLE mutations. Five POLE mutations (L424V, F367V and P286H/L/S) as well as the POLD1 mutation (S478N) were added after data collection to increase mutation coverage.
Barault, L. et al. (2024). The Idylla™ POLE Mutation Assay, A New Tool For Direct Mutation Detection From FFPE Tissue. AMP 2024 Annual Meeting.
434 tissue samples met all inclusion criteria1 and generated valid results with Idylla™ and the reference methods. The distribution of the detected mutations for the 175 mutated samples is displayed in the piechart2.
| Reference Methods | ||||
| Mutated | Wild Type | Total | ||
| Idylla™ | Mutated | 175 | 23 | 177 |
| Wild Type | 44 | 253 | 257 | |
| Total | 179 | 255 | 434 | |
| All samples (n=434) | Without low input samples (n=386) | |
| PPA5 | 97.7% | 100% |
| NPA6 | 99.2% | 99.2% |
| OPA7 | 98.6% | 99.5% |
≥ 10% tumor cells, ≥ 0.25 mm³ tissue area
Idylla™ reports the different mutations per exon.
2/2 false positive results were potentially due to the use of a lower sensitivity reference method (Sanger).
4/4 false negative results were obtained with a low amount of amplifiable DNA.
Positive percent agreement
negative percent agreement
overall percent agreement
