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LGC’s HyBeacons® technology is used in Europe’s first large-scale anticoagulation drug trial

01 Feb 2011

HyBeacons®genotyping technology - bringing personalised medicine to thrombosis patients

LGC, the international science-based company and market leader in analytical, forensic and diagnostic services and reference standards, is applying its HyBeacons® genotyping technology to Europe’s first-ever large scale trial of pharmacogenetic-guided anticoagulation therapy. LGC is pleased to announce that the first patient within the trial has been successfully genotyped and treatment has commenced.

LGC is collaborating with researchers from six European countries in the two-year EU trial, which will involve 3,000 patients and aims to demonstrate that a patient’s genotype plays an important role in the effective prescribing of anticoagulation (anti-blood-clotting) drugs such as Warfarin.

The trial is being co-ordinated by Dr Anke-Hilse Maitland-van der Zee, University of Utrecht, with the following academic partners: University of Utrecht, Faculty of Science, Utrecht, The Netherlands; Leiden University Medical Centre, Leiden, The Netherlands; Erasmus Medical Centre, Rotterdam, The Netherlands; Uppsala University, Uppsala, Sweden; Newcastle University, Newcastle Upon Tyne, UK;  University of Liverpool, Liverpool UK, Democritus University of Thrace, Alexandroupolis Greece; Humboldt University of Berlin, Berlin, Germany; Elisabethinen Hospital Linz, Linz, Austria.

LGC’s HyBeacons technology will be used to determine a patient’s genotype directly from blood. The HyBeacons assay will be carried out using a new point-of-care-instrument developed and manufactured by OptiGene Ltd. The methodology has been designed for clinical staff to work directly with a tiny blood sample and for the whole procedure of genotyping a patient to determine the appropriate dose of anticoagulant drug, to take less than two hours.

Anticoagulant drugs are used to prevent thrombosis (clots) and embolism (migration of a thrombus to a spot where it blocks blood supply to a vital organ) in many disorders. Dosing of these drugs is complicated by the fact that they are known to interact with many commonly used medications such as antibiotics and other chemicals that may be present in appreciable quantities in food, as well as other medical conditions such as hypo- or hyperthyroidism. These various interactions may enhance or reduce a drug’s anticoagulation effect.

When initiating the anticoagulant therapy, the doctor will decide how high the anticoagulant dosing needs to be. In order to optimise the therapeutic effect without risking dangerous side-effects, such as bleeding, close monitoring of the degree of anticoagulation is required by blood testing for the international normalised ratio (INR). Initially, checking may be as often as twice a week; the intervals can be lengthened if the patient manages stable therapeutic INR levels on an unchanged dose.

This trial aims to improve significantly the time within target INR range by adjusting the initial dosage of the anticoagulant drug according to the patient’s genotype. By doing that, side-effects can be minimised and a strategy for a more successful outcome from the medical treatment can be created. The use of personalised medicine moves away from ‘one size fits all’ towards a more tailor-made treatment resulting in a better clinical outcome for the patient.

The European Pharmacogenetics of Anticoagulant Therapy (EU-PACT) trial is funded by the Seventh Framework Program of the EU. The study is a two-armed, single-blind randomised controlled trial which will test the effectiveness of dosing regimens that include genetic factors compared with dosing regimens without these factors.

Dr Rita Barallon, LGC Genomics’ Service Business Manager, said: “This is one of the largest prospective trials in personalised medicine. Using LGC’s HyBeacons technology in this trial will provide valuable information on the value of genotype-guided dosing of coumarin derivatives within a controlled environment.”

Notes to editors

About OptiGene Ltd

OptiGene Limited (www.optigene.co.uk) is an SME based in Horsham, West Sussex, in the UK. OptiGene Limited’s extensive knowledge of optical & thermal systems has allowed it to develop a rapid and fully portable instrument for the isothermal amplification of DNA with fluorimeteric detection, the quality of which is superior to most laboratory based systems.

OptiGene has been developing both instrumentation and reagents that support amplification and detection of DNA and RNA. It has a wealth of experience, not only in instrument design and manufacture, but also in the research and development of novel chemistries and reagent systems.