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Idylla™ NRAS-BRAF*
Mutation Assay (RUO)

RAS genes still comprise the most frequently mutated oncogene family in human cancers being mutated e.g. in lung, colon, as well as pancreatic cancers¹. About 50% of all metastatic colorectal tumors harbor RAS mutations¹ with the frequency of NRAS (exons 2, 3 & 4) and BRAF being 5% and 8%, respectively².

The Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay allows detection of NRAS, BRAF and EGFR 492 mutations directly from formalin-fixed paraffin-embedded (FFPE) tissue sections in approx. 120 minutes with less than 2 minutes hands-on time.

The Idylla™ NRAS-BRAF Mutation Assay, performed on the Biocartis Idylla™ system, is a sample-to-result real-time PCR assay for the qualitative detection of mutations in codons 12, 13, 59, 61, 117, 146 of the NRAS oncogene, codon 600 of the BRAF oncogene and codon 492 of the EGFR gene. The Idylla™ NRAS-BRAF-EGFR S492R Mutation Assay directly liberates DNA from FFPE tissue for subsequent real-time PCR amplification and detection. Fully automated software interpretation and reporting is also integrated, and provides a result in approx. 120 minutes.

*included in the NRAS-BRAF-EGFR-S492R product

References

¹Cox AD et al. (2014) Nature Reviews Drug Discover 13, 828–851.
²Jean-Yves Douillard, M.D., Ph.D., Kelly S. Oliner, Ph.D., Salvatore Siena, M.D., et al. Panitumumab–FOLFOX4 Treatment and RAS Mutations in Colorectal Cancer. N Engl J Med 2013;369:1023-34.

Idylla™ NRAS-BRAF 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.