Abstract
Many modern therapies target oncogenic mutations identified in a patient’s biopsied tumor cells. The process of identifying these mutations can be costly, labor-intensive, and requires significant technical expertise. Biocartis’ Idylla system, a real time PCR-based machine, streamlines oncogenic DNA mutation testing, directly from formalin-fixed paraffin embedded tissue with only 2 minutes hands-on time The instrument reports the presence or absence of clinically-relevant oncogenic mutations in KRAS, EGFR, BRAF, and/or NRAS in ≤ 2.5 hours per sample. In this study, we tested how quickly and accurately the Biocartis Idylla detect oncogenic KRAS and EGFR mutations previously identified in 46 formalin-fixed paraffin embedded human patient biopsy samples. The Idylla successfully detected all of the oncogenic mutations with 100% accuracy. Based on these results, the Biocartis Idylla holds great clinical utility. It is an ideal tool in any clinical testing environment to provide a cost effective, quick and accurate test for identifying frequently observed oncogenic mutations in KRAS and EGFR.
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