Idylla KRAS Mutation Test

21 KRAS mutations in exons 2,3 and 4

~120 minutes assay turnaround time

< 2 minutes hands-on time

Only 1 slice of FFPE tissue required

Highly sensitive & standardized

Suitable for any lab

Idylla KRAS Mutation Test (CE-IVD)

A0020/6

The fully automated Idylla^TM KRAS Mutation Test covers 21 KRAS mutations in exons 2,3 and 4 showing an excellent concordance to reference methods of >95%. Comparison with various other KRAS detecting technologies revealed a superior performance of the Idylla^TM KRAS Mutation Test in terms of ease of use, turnaround time, and hands-on time while demonstrating superior levels of sensitivity.

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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

Clinical performance evaluation of a sensitive, rapid low-throughput test for KRAS mutation analysis using formalin-fixed, paraffin-embedded tissue samples

Weyn et al. - BMC Cancer. - February 2017

Comparison of the Idylla^TM KRAS Mutation Test to Qiagen's therascreen RGQ KRAS PCR Kit. While being highly concordant with Therascreen (96.7%), the Idylla^TM KRAS Mutation Test showed a significantly reduced invalid rate (<3% for Idylla^TM compared to 14% for therascreen).

Idylla Oncology Assays

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