Biocartis will present liquid biopsy data from the Company’s BRAF mutation study at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The study, in collaboration with Prof. Bart Neyns from the 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 (ctDNA) 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 utilize circulating tumor DNA (ctDNA) directly from patient blood samples to determine a tumor's genetic make-up.
Liquid biopsies are expected to play an important role in cancer treatment in the future. As this process is much less invasive than traditional biopsies, it could become a powerful approach for diagnosis, monitoring of treatment response and follow-up of patients after remission.
In collaboration with Prof. Bart Neyns’ team at the Department of Medical Oncology, Brussels, 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% of cases, while the mutations remained absent in patients with a good prognosis.
These observations are in line with a study presented by Dr. Janku (MD Anderson Cancer Center, Houston, Texas, USA) at the American Association for Cancer Research Annual Meeting in April of this year. These findings indicate that monthly monitoring of BRAF mutant ctDNA is likely to be useful for patient management in metastatic melanoma, which will be further validated in prospective trials.
Geert Maertens, Chief Scientific Officer of Biocartis, commented: “These data demonstrate Idylla’s potential application in liquid biopsies. We look forward to continuing our evaluations of ctDNA analysis in melanoma (BRAF) and colorectal cancer (extended RAS), where Idylla allows highly sensitive monitoring of 40 mutations at the same time. Hopefully, pushing the boundaries of detection even further might allow the diagnosis of early stages of cancer in the future, and patients will benefit from earlier and better optimized treatment regimens.”
Biocartis also 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 (MSI).
• 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.