Horizon Discovery Ltd. And DxS Ltd to Lead the Way in Setting Standards for Companion Diagnostic Tests

Published: Jul 22, 2009

Cambridge, UK, and Manchester, UK, Wednesday July 22nd 2009 – Horizon Discovery (Horizon) and DxS Limited, two UK companies promoting the development, approval and sale of companion diagnostic products, today announced a strategic collaboration that will see Horizon develop a panel of human isogenic cell models that recapitulate key drug sensitivity and resistance mechanisms in cancer patients that will be used to further develop DxS’ TheraScreen® range of clinical diagnostic kits.

Using a proprietary gene-engineering technology called GENESISTM, Horizon will generate a range of ‘X-MANTM’ (Mutant And Normal) cell-lines as a source of high-quality, genetically-defined human DNA that will be specifically used to assess the performance of DxS’ TheraScreen: K-RAS Mutation Kits. These kits enable clinicians to ascertain which patients will respond to anti-EGFR targeted colorectal cancer treatments including Erbitux™ and Vectibix™ based on K-RAS mutation status.

Around 40% of colorectal patients test positive for K-RAS mutations (a finding that was the subject of a seminal publication by Horizon co-founder Professor Alberto Bardelli in Cancer Research in March 2007); with the patients most likely to respond to the anti-EGFR therapies found in the remaining 60% (K-RAS wild type). This has led to a decision by the European Medicines Agency (EMEA) to make the testing of all colon cancer patients for these resistance genes compulsory before EGFR-targeted drugs can be prescribed. The American Society of Clinical Oncologists (ASCO) is similarly petitioning for the same guidelines to be adopted in the U.S. Current estimates indicate that approximately $750 million/year of savings will be conferred onto taxpayers and healthcare re-imbursers by the prescription of EGFR-drugs only to patients with a non-mutated K-RAS gene, who will benefit from the drugs.

Dr Chris Torrance, CEO of Horizon said “we are entering an age where we have enough information to have a significant impact on treating cancer. It now comes down to the time and money it currently takes to find and tailor new targeted treatments, it is Horizon’s mission to better coordinate all the stakeholders and regulators in the drug discovery process, such as the FDA, NIST and EMEA, to find ways of speeding this process up.”

“Our initial focus will be on evaluating new diagnostic kits from DxS using isogenic human mutant vs. normal DNA-controls, which we feel represent a ‘gold-standard’ means of bench-marking companion diagnostics where mutations often need to be detected in humans within a background of excess isogenic normal DNA.

Dr Stephen Little, CEO of DxS said, “This is an important and timely agreement for DxS which will allow us to work closely with Horizon, utilizing our combined technologies and expertise to further demonstrate the benefits of our TheraScreen: K-RAS Mutation Kits. As the companion diagnostic for Vectibix™ and Erbitux™ we are constantly working to ensure that our kit is considered the gold-standard in tumour mutation status testing, and are now looking ahead at development possibilities for future diagnostics.”

Horizon and DxS share a vision for personalised medicine and are leading the world in providing critical new tools that will enable a future where cancer patients will be screened for the genetic changes that drive their disease and then given the most effective targeted treatments to combat them.

Financial terms of the agreement were not disclosed.

About Horizon Discovery Ltd

Horizon Discovery is a translational genomics and personalised medicine company founded in June 2007 and is headquartered at the Babraham Research Campus, Cambridge, UK and with additional research laboratories in Torino, Italy. Horizon’s goal is to convert new information on the genetic causes of cancer into laboratory models that will facilitate the discovery of drugs that target these defects. Central to this aim is Horizon Discovery’s offering of isogenic cell-lines, which represent accurate models of defined cancer patient populations and their matched normal genetic backgrounds – a missing link in the rational and efficient development of novel targeted anti-cancer agents.

About DxS Ltd

DxS is a personalized medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies, DxS will support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics.

DxS has a continually expanding portfolio of cancer mutation products. The TheraScreen® range of CE-marked clinical diagnostic kits can identify genetic tumour mutations that affect how patients respond to cancer therapies, thus enabling doctors to provide the most beneficial treatment. DxS produces two clinical diagnostic kits, K-RAS and EGFR-29.

The TheraScreen: K-RAS Mutation kit is a companion diagnostic for Vectibix™ (Amgen) and Erbitux® (Merck KGaA) for the treatment of colorectal cancer. DxS has an exclusive global distribution agreement with Roche Diagnostics for the distribution of the TheraScreen: K-RAS and TheraScreen: EGFR29 Mutation kits.

DxS’ pioneering real-time PCR technology Scorpions® is highly regarded for its proven speed and sensitivity, and is combined with ARMS (allele specific PCR) to develop each unique DxS product. This class-leading technology is also available for license to diagnostic companies, for research, or for other varied applications.

DxS is a private, venture capital-backed company operating from the heart of Manchester’s Technology Quarter in the UK.

For further information please visit www.dxsdiagnostics.com

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