Reference Standards Acquires FDA Approval for Oncology Companion Diagnostic Test

Horizon Discovery Group plc has announced the use of its Reference Standards in a recent successful premarket approval application (PMA) filing with the FDA for a companion diagnostic in oncology by a leading next generation sequencing company. In the development and subsequent clinical trial, Horizon’s Reference Standards were used as positive controls to support the programme and to help establish the performance specifications of the assay.

Horizon is a leading provider of highly characterised genetic materials used as Reference Standards for the development and quality control of molecular assays. Increasingly the Company works with assay developers early in their process to support the efficient development and validation of new tests, often with the Reference Standards becoming part of the kit and Horizon receiving a portion of revenues.

Horizon has played a major role in the identification and application of the critical biomarkers of cancer since its inception. Horizon’s genetic markers are made available to researchers via its significant catalogue of products in the form of gene edited cell lines, and to clinical labs in the form of Reference Standards that mimic real patient samples.

Dr Darrin M Disley, Chief Executive Officer, Horizon Discovery, commented: “Due to our deep-seated experience, Horizon is a world-leader in the development of cell-based models of human disease and their application in a wide range of fields, including to support the accurate and efficient provision of critical oncology diagnostic testing. We are pleased that our Reference Standards have proven such a valuable component of this seminal clinical trial and FDA approval with one of the world’s leading players in the genomics and diagnostics market. We are currently supporting many similar trials and products and look forward to making an impact on the lives of patients through our products.”