Molecular

“Idylla™ BRAF Mutation Test
The fully automated IdyllaTM BRAF Mutation Test covers BRAF V600E, E2, D, K, R and M mutation with a sensitivity of 1% of mutant in wild type background in FFPE samples with an excellent concordance to reference methods of >95%.

Idylla™ KRAS Mutation Test
The fully automated IdyllaTM KRAS Mutation Test covers 21 KRAS mutations in exons 2,3 and 4 showing an excellent concordance to reference methods of >95%. Comparison with various other KRAS detecting technologies revealed a superior performance of the IdyllaTM KRAS Mutation Test in terms of ease of use, turnaround time, and hands-on time while demonstrating superior levels of sensitivity.

Idylla™ NRAS-BRAF Mutation Test
The fully automated IdyllaTM NRAS-BRAF Mutation Test covers 18 mutations in NRAS exons 2,3 and 4 as well as 5 mutations in BRAF codon 600 showing an excellent concordance to reference methods of >99%.

Idylla™ EGFR Mutation Test
Within 150 minutes and with less than 2 minutes hands-on time, the fully automated IdyllaTM EGFR Mutation Test covers 51 mutations in exons 18–21 in a single cartridge using only 1 FFPE tissue section from metastatic NSCLC showing a high concordance of >95% compared with reference methods.

Idylla™ GeneFusion Panel Test
Within 180 minutes and with less than 2 minutes hands-on time, the fully automated Idylla™ GeneFusion Panel detects ALK, ROS1 and RET fusions & MET exon 14 skipping in a single cartridge using only 1-3* FFPE tissue sections from patients with NSCLC.

Idylla™ MSI Test
The fully automated IdyllaTM MSI Test performs the detection of microsatellite instability directly from formalin-fixed paraffin embedded (FFPE) human cancer tissue sections utilizing a PCR reaction followed by high-resolution melting curve analysis. The fully automated samples-to-result process with integrated automated software interpretation and reporting makes this MSI analysis fast and easy-to-use in virtually any laboratory setting.

The fully automated IdyllaTM MSI Test performs detection of mutations in 7 novel MSI loci (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A, and SULF2). These biomarkers are tumor-specific, show a high frequency in colorectal cancer and are stable across different ethnicities ensuring excellent specificity of the test. In addition, these tumor-specific biomarkers do not require the analysis of paired normal tissue samples associated with traditional MSI/dMMR testing.

With its high concordance (> 97%) and low failure rates compared to standard methods, the IdyllaTM MSI Test provides a fast, convenient and reliable alternative for any lab.

For more information, please visit the Biocartis website.