LGC’s genotyping technology used to study genetic basis for
28 Feb 2011
LGC, a specialist 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
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 outcome is expected to bring
personalised medicine to thrombosis patients.
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
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 trails 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.”