LGC is applying its Hybeacons genotyping technology to Europe's first-ever large-scale trial of pharmacogenetic-guided anticoagulation therapy, to treat thrombosis and embolism in many disorders.
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, Leiden University Medical Centre and Erasmus Medical Centre all in the Netherlands; Uppsala University, Sweden; Newcastle University, UK; University of Liverpool, UK; Democritus University of Thrace, Alexandroupolis, Greece; Humboldt University of Berlin, Germany; Elisabethinen Hospital 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.
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 Programme of the EU.
The study is a two-armed, single-blind randomised controlled trial that will test the effectiveness of dosing regimens that include genetic factors compared with dosing regimens without these factors.