Horizon Discovery Reference Standards for Biocartis Idylla MSI Assay

Horizon Discovery has launched a set of precisely defined cell line-derived reference standards to support Biocartis' recently launched Idylla microsatellite instability (MSI) Assay. The Idylla MSI Assay (RUO) allows for qualitative detection of a novel panel of seven monomorphic homopolymer biomarkers to identify human cancers with microsatellite instability, in a fully automated manner. The assay uses formalin-fixed, paraffin-embedded tissue sections from human cancer samples, and extracts, amplifies, and analyzes the nucleic acids.

Horizon's newly developed MSI FFPE reference standards, which were developed in a collaboration between the two companies, enable validation and routine monitoring of MSI testing on the Idylla platform. The reference standard material consists of a pair of FFPE sections, positive and negative for all seven MSI markers, providing a whole-process control that closely mimics a real FFPE sample. The reference standard is manufactured under ISO13485 at Horizon.