CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
July 2015—Biocartis presented liquid biopsy data from the company’s BRAF mutation study at the American Society of Clinical Oncology annual meeting in June. The study, in collaboration with Bart Neyns, MD, PhD, University Hospital Brussels, showed that BRAF oncogene mutations monitored in plasma from metastatic melanoma patients on Biocartis’ Idylla system were significantly associated with treatment response and progression.
Idylla is a fully automated diagnostic platform designed to offer fast access to molecular diagnostic information from virtually any clinical sample type. In the current study, Biocartis developed a prototype product on its Idylla system for the analysis of BRAF mutations in circulating tumor DNA from plasma samples. The prototype integrates and fully automates extraction of ctDNA and powerful selective amplification enabling the sensitive detection of BRAF V600 mutations from 1 mL of plasma. Liquid biopsies use circulating tumor DNA directly from patient blood samples to determine a tumor’s genetic makeup.
In collaboration with Dr. Neyns’ team at the Department of Medical Oncology, 232 plasma samples from 41 patients with metastatic melanoma were analyzed for circulating levels of mutant BRAF using Idylla. The findings showed, among others, that BRAF V600 mutations in plasma detected by Idylla were significantly associated with disease progression, and preceded or coincided with disease progression on imaging in 100 percent of cases, while the mutations remained absent in patients with a good prognosis.
Biocartis presented two other studies at ASCO demonstrating significant progress in the development of its Idylla colorectal cancer menu: a study on a novel Idylla prototype for fully automated detection of homopolymers specific for microsatellite instability and a presentation of verification data and alpha trial results of the Idylla KRAS Mutation Assay showing highly specific and sensitive detection of 21 mutations in biopsy tissue.
Biocartis, +32 15 632 600