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Idylla™ EGFR
Mutation Assay (RUO)

The epidermal growth factor receptor, EGFR, is a cellular transmembrane receptor expressed in a number of different tumor types including prostate and non-small cell lung cancer (NSCLC)¹,². The prevalence of EGFR mutations in NSCLC is 10-15% in Western and up to 50% in Asian patients². The most common EGFR mutations are the L858R mutation in exon 21 and deletions in exon 19².

The Idylla™ EGFR Mutation Assay allows detection of EGFR mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue sections in approx. 150 minutes with less than 2 minutes hands-on time.

The Idylla™ EGFR Mutation Assay, performed on the Biocartis Idylla™ system, is a sample-to-result real-time PCR assay available for the qualitative detection of 51 mutations in exons 18, 19, 20 and 21 of the EGFR gene. The Idylla™ EGFR Mutation Assay efficiently liberates DNA directly from FFPE tissue and performs multiplex real-time PCR amplification and detection. Fully automated software interpretation and reporting is also integrated, and provides a result in approx. 150 minutes.

References

¹Kharmate G (2016) PLoS One 11(5): e0154967
²Cooper et al., Molecular biology of lung cancer. J Thorac Dis (2013)

Idylla™ EGFR Mutation Assay is for Research Use Only. Not for use in diagnostic procedures.

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Biocartis is recruiting centers for a prospective biomarker study comparing turnaround times of standard of care methods and biomarker testing with Idylla™.

One of the biggest challenges oncology labs face with biomarker testing is the ability to obtain samples of sufficient size and quality. With the Idylla™ system only a minimal amount of sample is needed. For solid biopsies, just one slice of tissue is enough and our plasma-based assays require only 1 ml of plasma.