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Idylla™ BRAF
Mutation Assay (RUO)

Mutations in the BRAF gene have been reported in 7%–15% of all human cancers, with melanoma having one of the highest incidences (40%–70%). Other tumor types with a marked prevalence of BRAF V600 mutations include ovarian cancer (35%), colorectal cancer (12%), non-small cell lung cancer (NSCLC; up to 5%) and multiple myeloma (4%)¹.

The Idylla™ BRAF Mutation Assay detects BRAF mutations directly from FFPE tissue sections in 90 minutes with less than 2 minutes hands-on time.

The Idylla™ 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 codon 600 of the BRAF oncogene. The Idylla™ BRAF 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. 90 minutes.

References

¹Cohn AL et al. (2017) Onco Targets Ther. 10: 965–971.

Idylla™ 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.