Idylla POLE-POLD1 Mutation Assay

17 POLE and 1 POLD1 pathogenic mutations

~95 minutes assay turnaround time

< 3 minutes hands-on time

Only 1 FFPE tissue section required*

Highly sensitive & standardized

Suitable for any lab

IDYLLA^TM 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 MULTI-CENTER STUDY HIGHLIGHTS THE ASSAY’S POTENTIAL IN ENDOMETRIAL CANCER RESEARCH

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.

IDYLLA™ DEMONSTRATED 98.6% ACCURACY WITH ENDOMETRIAL CANCER SAMPLES

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.

Table 1. Aggregated results comparing Idylla™ and the reference methods.
		Reference Methods
		Mutated	Wild Type	Total
Idylla™	Mutated	175	2**	177
	Wild Type	4*	253	257
	Total	179	255	434

*4/4 false negative results were obtained with a low amount of amplifiable DNA. **2/2 false positive results were potentially due to the use of a lower sensitivity reference method (Sanger).

Table 2. Concordance rates of Idylla™ with the reference methods.
	All samples (n=434)	Without low input samples (n=386)
PPA	97.7%	100%
NPA	99.2%	99.2%
OPA	98.6%	99.5%

≥ 10% tumor cells, ≥ 0.25 mm³ tissue area
Idylla™ reports the different mutations per exon.

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