Belgium-based molecular diagnostics firm Biocartis has launched Idylla ctEGFR Mutation Assay (RUO), a liquid biopsy version of its solid biopsy Idylla EGFR Mutation Test (CE-IVD).
The Idylla ctEGFR Mutation Assay detects 49 EGFR mutations from 2ml of blood plasma and offers results in around 160 minutes.
A first performance study, which included 64 non-small cell lung cancer samples, showed that the Idylla ctEGFR Mutation Test detected all those mutations identified by next-generation sequencing (NGS).
In addition to the identification of these mutations, the liquid biopsy assay, which is performed on the Idylla platform, could detect another eight mutations in this sample group, while the NGS failed to detect mutations in 33 samples.
Biocartis chief executive officer Herman Verrelst said: “We are excited to further expand our Idylla menu of tests with the launch of the liquid biopsy ctEGFR Mutation Assay (RUO). Operating directly on only 2ml of blood plasma, this assay provides our customers with the ease-of-use and speed of the Idylla platform and has great potential to provide solutions in cases where cancer tissue is not or not sufficiently available.
“This assay launch further strengthens our testing menu, which will be further complemented by the expected launch of our Idylla GeneFusion Panel next year, focused on the detection of different gene fusions that are currently recommended in the guidelines.”
Samples of sufficient quantity and quality are essential for biomarker testing in several cancer types.
In cases where the solid tumour tissue samples are not of sufficient quantity, the tumour content is too low or too hard-to-reach, the liquid biopsy testing could offer a solution, claimed the company.
In February, Biocartis announced receipt of the CE-IVD marking for its completely automated Idylla MSI Test, which offers quick information on a patient’s MSI status from one sample of FFPE colorectal cancer tumour tissue.