Idylla EGFR Mutation Assay

51 EGFR mutations in exons 18, 19, 20 and 21

~150 minutes assay turnaround time

< 2 minutes hands-on time

Only 1 slice of FFPE tissue required

Highly sensitive & standardized

Suitable for any lab

The fully automated Idylla^TM EGFR Mutation Assay covers 51 mutations in exons 18–21 in a single cartridge using a single FFPE section and shows a high concordance of >95% compared with reference methods.1 2

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For research use only. Not for use in diagnostic procedures.

1Browhan et al., J Diagn Tech Biomed Anal 2018, 7:2
2Arcila M et al., Journal of Molecular Diagnostics; 2018, 20:6. Abstract #ST027

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^TM system only a minimal amount of sample is needed

1x 5 μm FFPE tissue section
Neoplastic cells ≥10% - if less, macrodissection is required

Testimonial

The Idylla™ EGFR Mutation Assay is so fast that we can now provide results within 24 hours, while at the same time save costs and resources in the lab.”

Yi Ding, MD, PhD
Geisinger, Danville, P.A.

The opinions and conclusions expressed in the following publications are those of the individual authors and do not necessarily reflect the views and opinions of Biocartis and/or its employees.

Idylla assay and next generation sequencing: an integrated EGFR mutational testing algorithm

De Luca et al. Journal of Clinical Pathology 2018;71:745-750.

The Idylla^TM EGFR Mutation Test was compared to retrospective NGS results obtained with the Ion Torrent NGS system showing 100% concordance for the samples that had a valid NGS result. In addition the Idylla^TM EGFR Mutation Test was able to rescue 80% of the EGFR samples whose assessment was unsuccessful with NGS, identifying several actionable EGFR mutations.

Biocartis Idylla proves fast and accurate in detecting oncogenic KRAS and EGFR mutations in paraffin embedded tumor samples

Browhan et al., J Diagn Tech Biomed Anal 2018, 7:2

Idylla™ performance study on FFPE samples from colorectal and non-small cell lung cancer using Idylla™ Mutation Assays for EGFR and KRAS. Biomarker analysis utilizing Idylla™ was 100% accurate. The Idylla™ results were available more than 13 times faster than the reference methods and were noted as cost effective, quick, and accurate.

Idylla Research Assays

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