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Horizon Discovery announces inclusion of its Reference Standards in successful FDA approval of an oncology companion diagnostic test with leading next generation sequencing company

Horizon Discovery announces inclusion of its Reference Standards in successful FDA approval of an oncology companion diagnostic test with leading next generation sequencing company

  • Horizon's reference standards supported assay development and subsequent clinical trial
  • Horizon is a leader in the application of cancer biomarkers in diagnostics and research

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 the case in a previously announced agreement (12 May 2016) with a global market leading Next Generation Sequencing (NGS) platform company.

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.

Colorectal cancer is one of the most commonly diagnosed cancers in both men and women, with an estimated 135,000 new cases expected to be diagnosed in 20171 in the United States alone. Current front-line colorectal cancer drugs exist in the forms of Erbitux and Vectibix, however not all patients respond to the therapeutics. Studies from Professor Alberto Bardelli (a Horizon co-founder) and Dr. Sabine Tejpar (a Horizon SAB member), published in the Journal of Cancer Research (March 2007 and February 2009) and the Journal of Clinical Oncology (October 2008), first made the link between K-RAS mutations and resistance to these drugs in up to 65% of colon cancer patients2. This work provided critical evidence that led to the requirement for clinicians to test patients for K-RAS mutation status prior to their prescription, not only enabling patients to obtain the right drug for their cancer, but also saving an estimated $750 million/year through avoidance of prescriptions that would provide no patient benefit.

Horizon continued to build on this work through the COLTHERES consortium, a four year €6 million funded collaboration of EU-based clinical centers and translational researchers, that identified additional biomarkers in the 30-40% of patients who are resistant to Cetuximab, a therapeutic for the treatment of advanced colorectal cancer. This work led to multiple ongoing clinical trials for combination therapies, and resulted in several technical innovations including the first practical use of liquid biopsy for diagnostics, the full impact of which is now being realised.

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."

  1. https://seer.cancer.gov/statfacts/html/colorect.html
  2. https://www.horizondiscovery.com/about-us/news/horizona-s-x-man-cell-models-predict-that-a-subset-of-kras-mutated-cancers-respondto-egfr-therapy

ENDS

About Horizon's Reference Standards:
There are many potential sources of variability that can lead to molecular diagnostic tests providing erroneous results. Our 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, purified genomic DNA (gDNA), and cell-free DNA (cfDNA) on its own or spiked into synthetic plasma.

Glossary:

  1. Assay: a laboratory procedure measuring the presence, amount, or functional activity of a specific biomarker or analyte
  2. Liquid biopsy: the sampling and analysis of non-solid biological tissue, primarily blood
  3. K-RAS: a protein that in humans is encoded by the KRAS gene
  4. Next Generation Sequencing (NGS): high-throughput sequencing of DNA (or RNA) by parallelising the sequencing process, producing thousands or millions of sequences concurrently
  5. Reference standard: a standardised substance (e.g. DNA, protein) which is used as a measurement base or control for an assay
  6. https://seer.cancer.gov/statfacts/html/colorect.html
  7. https://www.horizondiscovery.com/about-us/news/horizona-s-x-man-cell-models-predict-that-a-subset-of-kras-mutated-cancers-respondto-egfr-therapy

For further information from Horizon Discovery Group plc, please contact:

Horizon Discovery Group plc
Darrin Disley, Chief Executive Officer
Richard Vellacott, Chief Financial Officer
Chris Claxton, VP Investor Relations
Tel: +44 (0) 1223 655 580

Consilium Strategic Communications (Financial Media and Investor Relations)
Mary-Jane Elliott / Susan Stuart / Matthew Neal / Melissa Gardiner
Tel: +44 (0) 20 3709 5701
Email: horizon@consilium-comms.com

Zyme Communications (Trade and Regional Media)
Katie Odgaard
Tel: +44 (0)7787 502 947
Email: katie.odgaard@zymecommunications.com
Tel: +44 (0) 20 7653 4000

About Horizon Discovery Group plc www.horizondiscovery.com
Horizon Discovery Group plc (LSE: HZD) ("Horizon"), is a world-leading gene editing company that designs and engineers genetically-modified cells and then applies them in research and clinical applications that advance human health.

Horizon's core capabilities are built around its proprietary translational genomics platform, a highly precise and flexible suite of gene editing tools (rAAV, ZFN, CRISPR and Transposon) able to alter almost any gene sequence in human or mammalian cell-lines.

Horizon offers over 23,000 catalogue products and related research services, almost all of which are based on the generation and application of cell and animal models that accurately recapitulate the disease-causing genetic anomalies found in diseases like cancer. Horizon's commercial offering has been adopted by over 1,600 unique research organisations in over 50 countries as well as in the Company's own R&D pipeline to support a greater understanding of the genetic drivers of disease and the development of molecular, cell and gene therapies that can be prescribed on a personalised basis.

Horizon is headquartered in Cambridge, UK, and is listed on the London Stock Exchange's AIM market under the ticker "HZD".

Source:Horizon Discovery Group plc