IDYLLATM POLE-POLD1 MUTATION ASSAY (RUO) WILL BE AVAILABLE SOON
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 98.3% accuracy with 435 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
One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. With the Idylla™ System only a minimal amount of sample is needed:
- 1x 5 μm FFPE tissue section if tissue area 50-600 mm²
- 1x 10 μm FFPE tissue section if tissue area 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.
435 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 | 54 | 253 | 258 | |
| Total | 180 | 255 | 435 | |
| All samples (n=435) | Without low input samples (n=387) | |
| PPA5 | 97.2% | 99.3% |
| NPA6 | 99.2% | 99.1% |
| OPA7 | 98.3% | 99.2% |
> 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).
4/5 false negative results were obtained with a low amount of amplifiable DNA.
Positive percent agreement
negative percent agreement
overall percent agreement