诊断技术与生物医学分析杂志

Biocartis Idylla proves Fast and Accurate in Detecting Oncogenic KRAS and EGFR Mutations in Paraffin Embedded Tumor Samples

David Graf Brohawn, Xiaofeng Mu, Zhuang Tong, Elizabeth Rao, Ye Wang and Xinmin Li*

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.