Biocartis – Idylla POLE-POLD1 Mutation Assa

The Idylla™ POLE-POLD1 Mutation Assay (RUO)* provides a rapid and reliable solution to close an important gap in oncology research by enabling molecular classification of endometrial cancer samples. Its fully automated solution is capable to detect 99% of the known pathogenic POLE and POLD1 mutations and it demonstrated 98.6% accuracy with 434 endometrial cancer tissue samples.

Key Idylla POLE-POLD1 Mutation Assay features:

• Qualitative detection of > 95% of the POLE mutations associated with the hypermutated phenotype in endometrial and colorectal cancer samples ^{1, 2}
  • Exon 9: P286H, P286L, P286R, P286S, M295R, S297F
  • Exon 11: F367S, F367V, D368Y
  • Exon 13: V411L, L424I, L424V, P436R, M444K
  • Exon 14: A456P, S459F
  • Additionally, one mutation in POLD1 is detected: S478N

• For use on the fully automated Idylla™ Platform. On-demand testing (no sample batching required).
• Directly from FFPE tissue sections.
• Results in only 2 hours with approximately 3 minutes hands-on time.

Assay 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

Empower your laboratory to streamline molecular profiling for endometrial cancer and beyond.

References:

¹ León-Castillo, A. et al. (2020). Clinicopathological and molecular characterisation of ‘multiple-classifier’ endometrial carcinomas. The Journal of pathology, 250(3), 312–322. https://doi.org/10.1002/path.5373

² Ambrosini, M. et al. (2024). Immune checkpoint inhibitors for POLE or POLD1 proofreading-deficient metastatic colorectal cancer. Ann Oncol., 35(7), 643-655. https://doi.org/10.1016/j.annonc.2024.03.009

* Research use only (RUO)

THESE PRODUCTS ARE NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.

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