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IdyllaTM EGFR Mutation Test (CE-IVD)

The fully automated Idylla™ EGFR Mutation Test (CDx) identifies 44 mutations across exons 18–21 of the EGFR gene in just 150 minutes, with less than 3 minutes hands-on time.

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Description

A0270/6

The fully automated Idylla™ EGFR Mutation Test (CDx) identifies 44 mutations across exons 18–21 of the EGFR gene in just 150 minutes, with less than 3 minutes hands-on time. Requiring only two FFPE tissue sections from patients with non-small cell lung cancer (NSCLC), the test demonstrates high accuracy, showing a concordance of over 98% with an established PCR method.

Download Leaflet: egfr_ivdr_-_technical_sheet_-_may2025

Specimen requirements

One of the biggest challenges in oncology biomarker testing is the ability to obtain samples of sufficient size and quality. With the IdyllaTM System only a minimal amount of sample is needed

  • 2 to 4 FFPE tissue sections (5-10 μm)
  • Neoplastic cells ≥20% –  if less, macrodissection is required