LGC's HyBeacons® technology is used in Europe's first large-scale anticoagulation drug trial
HyBeacons® genotyping technology - bringing personalised medicine to thrombosis patients
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 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."
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.
LGC Genomics GmbH
About LGC Genomics
A division of the LGC Group, LGC Genomics (lgcgenomics.com) delivers high quality services and products for DNA and genetic analysis and sample preparation including:
- Next generation sequencing services
- DNA sequencing, genomic services
- Nucleic acid extraction services
- DNA extraction products
- pharmacogenetics and diagnostic services.
LGC (www.lgc.co.uk) is an international science-based company and market leader in analytical, forensic and diagnostic services and reference standards. LGC operates in a variety of markets which underpin the safety, health and security of the public and the regulation of industry, for both public and private sector clients.
LGC operates internationally through four divisions - LGC Forensics, LGC Genomics, LGC Standards and LGC Science & Technology. The latter includes specialist laboratories delivering contracts for the Department for Business, Innovation and Skills (BIS) and supports LGC's designated role as the UK's National Measurement Institute for chemical and bioanalytical measurement.
Our operations are extensively accredited to international quality standards such as ISO 17025. With headquarters in Teddington, South West London, the LGC Group employs ca 1,400 staff in 29 laboratories and centres globally. Privatised in 1996 and now majority-owned by funds managed by Bridgepoint, LGC was founded almost 170 years ago as the Laboratory of the Government Chemist - a statutory function maintained by LGC today.