Idylla KRAS Mutation Assay

21 KRAS mutations in exons 2,3 and 4

~130 minutes assay turnaround time

< 2 minutes hands-on time

Only 1 slice of FFPE tissue required

Highly sensitive & standardized

Suitable for any lab

The Idylla^TM KRAS Mutation Assay detects KRAS mutations directly from FFPE tissue sections in approx. 130 minutes with less than 2 minutes hands-on time.

The Idylla^TM KRAS Mutation Assay, performed on the Biocartis Idylla^TM System, is a sample-to-result real-time PCR assay for the qualitative detection of mutations in codons 12, 13, 59, 61, 117, 146 of the KRAS oncogene.

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

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 → 50-600 mm²
1x 10 μm FFPE tissue section → 25-300 mm²
Neoplastic cells ≥10% - if less, macrodissection is required

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.

Key differences between 13 KRAS mutation detection technologies and their relevance for clinical practice

Sherwood et al. - ESMO Open. - September 2017

This large comparison study performed by AstraZeneca blindly assessed KRAS mutation detection in 13 different clinically available technologies, using five distinct KRAS-mutant cell lines. The study showed that the Idylla^TM KRAS Mutation Assay was not only ranked as the fastest and easiest to use, but also required the lowest amount of hands on time while maintaining excellent performance.

Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC.

Colling et al. - J Clin Pathol. - June 2017

Comparison of Idylla^TM KRAS and NRAS-BRAF-EGFR S492R Mutation Assays to NGS. Idylla^TM assays showed an overall concordance of 100% with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS.

Rapid somatic mutation testing in colorectal cancer by use of a fully automated system and single-use cartridge: a comparison with next-generation sequencing

Al-Turkmani et al. - JALM - August 2018

Comparison of the Idylla^TM KRAS and NRAS-BRAF-EGFRS492R Mutation Assay with NGS using colorectal cancer tissue samples showing an overall agreement of 100%.

Idylla Research Assays

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