Horizon and DxS to Lead the Way in Setting Standards for Companion Diagnostic Tests in Cancer

22 Jul 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 GENESIS™, Horizon will generate a range of ‘X-MAN™’ (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.