Idylla EGFR Mutation Test (CE-IVD)
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.
Idylla™ EGFR Mutation Test (A0270/6) is CE-marked in Europe in compliance with the EU IVD Regulation 2017/746 (IVDR). Idylla™ EGFR (A0060/6) Mutation Test is CE-marked in Europe in compliance with the EU IVD Directive 98/79/EC and registered in many non-European markets. Please check availability with a Biocartis representative. For more information on the PlexZyme and PlexPrime license statements, click here.
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
TESTIMONAL
In this recording, Dr Leo Tallafigo Moreno highlights "the importance of adequate diagnosis in lung cancer and the transformative impact of Idylla™ EGFR in thoracic oncology".1
This video presentation has been prepared by Dr Leo Tallafigo Moreno, who has received a fee from Biocartis NV for his contribution. The content is intended for educational purposes and reflects the personal views of the presenter. It has not been reviewed or modified by Biocartis NV. This video is sponsored by Biocartis NV. Please consult a healthcare professional for medical advice specific to your condition. The Idylla™ EGFR Mutation Test is validated for the use of FFPE tissue in metastatic NSCLC.
Testimonial
Today, EGFR testing is a cumbersome process and it often takes several weeks before results are analyzed. This may lead to the administration of anti-EGFR therapy as second-line agents, which is less efficient than their use in first-line therapy. The IdyllaTM EGFR Mutation assay technology has the potential to change that; it is a cost-effective solution, ensuring reliable and fast detection of all relevant mutations.
Prof Giancarlo Troncone
University of Napoli Federico II, Naples, Italy
