Study Demonstrates Ability of Idylla EGFR Mutation Test in Failed NGS

Biocartis Group NV, an innovative molecular diagnostics company, announces the publication of a study in the Journal of Clinical Pathology demonstrating that the Idylla(TM) EGFR Mutation Test (CE-IVD) was able to rescue 80 percent of the EGFR samples whose assessment was unsuccessful with Next Generation Sequencing (NGS). The study concluded that the Idylla(TM) EGFR Mutation Test is a viable alternative to NGS for rapid treatment decisions in patients with acute deterioration, in particular when testing is performed on a less than optimal tumor tissue sample, which frequently yields insufficient amounts of DNA for proper NGS analysis. The study, conducted by amongst others Prof. Giancarlo Troncone, Professor of Anatomic Pathology of the Department of Public Health, University of Naples Federico II (Naples, Italy) and Prof. Massimo Barberis, Director of Histopathology and Molecular Diagnostics Unit of the Division of Pathology and Laboratory Medicine, Istituto Europeo di Oncologia (Milan, Italy), included 68 archival DNA samples previously processed by NGS. A total of 43 had a valid NGS result and 25 (37 percent) had an invalid NGS result.

These samples were retested by directly pipetting the DNA into the Idylla(TM) EGFR Mutation Test cartridge. There was a 100 percent concordance with NGS for the valid results, where Idylla(TM) confirmed the EGFR mutational status. For a large portion (20/25 or 80 percent) of the cases whose NGS assessment was invalid, Idylla(TM) was able to process the sample and adequately produced a result. In 4/25 (16 percent) of these cases, Idylla(TM) detected actionable EGFR mutations, which means a larger patient population that could potentially benefit from targeted treatments. Lung cancer testing today is often complex because of the limited amount of lung cancer tissue available, which frequently leads to failure of test results. The Idylla(TM) EGFR Mutation Test is performed on Biocartis’ Idylla(TM) system and allows the detection of 51 EGFR mutations, which are included in international guidelines for all patients with advanced NSCLC of a non-squamous subtype, directly from only one slice of FFPE tumor tissue. The test delivers results in approx. 2.5 hours with less than 2 minutes hands-on time.

Giancarlo Troncone, MD, PhD, Professor of Anatomic Pathology, University of Naples Federico II (Naples, Italy), commented: “Timely communication between oncologists and molecular pathologists is crucial, in particular for acute deteriorating patient clinical management. Our data showed that, when clinical decisions should be taken quickly to save time since days have been spent on waiting for an invalid NGS result, Idylla(TM) can provide a solution.” Lung cancer is the cancer with the highest incidence worldwide. The launch of Biocartis’ fully automated Idylla(TM) liquid biopsy ctEGFR Mutation Assay (RUO) is planned for H2 2018. – Medical Buyer Bureau