11/01/2018 | Press release | Distributed by Public on 11/01/2018 09:04
Cambridge, UK, 01 November 2018: Horizon Discovery Group plc (LSE: HZD) ('Horizon' or 'the Company'), a global leader in gene editing and gene modulation technologies, today announces that it has developed a set of precisely defined cell line-derived reference standards to support Biocartis' recently launched Idylla™ microsatellite instability (MSI) Assay 1.
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 (MSI), in a fully automated manner. The Assay uses formalin-fixed, paraffin-embedded (FFPE) tissue sections from human cancer tissue, from which nucleic acids are extracted, amplified and then analyzed. Horizon's newly developed MSI FFPE reference standards enable validation and routine monitoring of MSI testing on the Idylla™ platform.
Dr Chris Lowe, Head of Research Operations, Horizon Discovery, commented: 'Horizon pioneered the development of genetically defined, well-characterized cell line derived reference standards, and this collaboration with Biocartis further validates our position as the leader in the field. Our teams are continually innovating to expand this range and we are proud to offer a sustainable source of reference material to support accurate assay results when examining MSI on the Idylla™ platform.'
Erwin Sablon, VP Alliance Management & Partnerships of Biocartis, said: 'The collaboration between Biocartis and Horizon has contributed greatly to the successful market launch of the Idylla™ MSI Assay in July 2018. We continue to be impressed with the quality of Horizon's reference standards.'
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. The CE-marking of the Idylla™ MSI Assay for in vitro diagnostic use in colorectal cancer is anticipated in the first half of 2019.
1 The Idylla™ MSI Assay is intended for research use only (RUO) and is not approved for use as a diagnostic assay. Idylla™ is a trademark of Biocartis.
About Horizon's reference standards: There are many potential sources of variability that can lead to molecular diagnostic tests providing erroneous results. Horizon's reference standards offer a source of genetically defined, quantitative, sustainable and independent third-party reference material, critical to the validation and routine performance monitoring of assays, providing an unprecedented level of control. Horizon reference standards are available in a broad range of formats, including formalin-fixed paraffin-embedded (FFPE) cell line sections, formalin-compromised DNA (fcDNA), purified genomic DNA (gDNA), and cell-free DNA (cfDNA) on its own or spiked into synthetic plasma.