Idylla™ EGFR Mutation Assay (RUO)


Lung cancer is the most common cancer worldwide, contributing for 13% of all cancer types1. 85% of lung cancers are non-small cell lung cancers (NSCLC), of which histologically adenocarcinoma is the most prevalent2. The prevalence of EGFR mutations in NSCLC is 10-15% in Western and up to 50% in Asian patients3. The most common EGFR mutations are the L858R mutation in exon 21 and deletions in exon 194.



The Idylla™ EGFR Mutation Assay allows detection of EGFR mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue sections in approx. 2.5 hours with less than 2 minutes hands-on time.


  • Directly on FFPE tissue sections
  • Minimum 1 x 5 µm FFPE tissue section with ≥ 10% tumor cells
  • Approx. 2.5 hours total turnaround time from sample to result
  • Less than 2 minutes hands-on time
  • Detection of 52 relevant mutations in exons 18, 19, 20 and 21
  • Highly standardized
  • An average sensitivity of ≤1 to ≤5% based on research data
  • Contamination-controlled design



1Navani et al., Lancet Respir Med (2015)
2American Cancer Society. Global Cancer Facts & Figures 2nd Edition (2011)
3Cooper et al., Molecular biology of lung cancer. J Thorac Dis (2013)
4NCCN Guidelines on Non-Small Cell Lung Cancer Version 4.2016

Highly standardized


The Idylla™ EGFR Mutation Assay, performed on the Biocartis Idylla™ system, is an assay available for the qualitative detection of 53 mutations in exons 18, 19, 20 and 21 of the EGFR gene. The Idylla™ EGFR Mutation Assay efficiently liberates DNA directly from FFPE tissue of human non-small cell lung cancer and performs multiplex real-time PCR amplification and detection. Fully automated software interpretation and reporting is also integrated and provides a result in approx. 2.5 hours.


Idylla™ EGFR Mutation Assay is intended for Research Use Only.
Not for sale in the USA and Canada.


For product availability in your country contact us via customerservice@biocartis.com.