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Idylla™ KRAS
Mutation Assay (RUO)

KRAS is one of the most frequently mutated oncogenes in human cancer, mutated in most pancreatic cancers (>90% of Pancreatic ductal adenocarcinoma) and 22-36% in lung cancer¹. About 45 percent of all metastatic colorectal tumors harbor mutations in exon 2, 3 and 4 of the KRAS oncogene¹. Idylla™ KRAS Mutation Assay detects KRAS mutations directly from FFPE tissue sections in approx. 120 minutes with less than 2 minutes hands-on time.

The Idylla™ KRAS 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 KRAS oncogene. The Idylla™ KRAS 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.

References

¹Cox AD et al. (2014) Nature Reviews Drug Discover 13, 828–851.

Idylla™ KRAS 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.