Horizon Discovery announces inclusion of Reference Standards in FDA approval

Horizon’s reference standards supported an assay development and subsequent clinical trial

Written byHorizon Discovery
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Cambridge, UK, 3 July 2017: Horizon Discovery Group plc (LSE: HZD) ("Horizon" or the “Company”), the world leader in the application of gene editing technologies, today announces 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, as was ...

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