MacRobert Award

2003 Winner

Randox Laboratories Ltd

Picture showing a Randox staff working at a fully automated diagnostic analyserRandox Laboratories Ltd of Northern Ireland has developed a fully automated diagnostic analyser (Evidence®) using protein biochip array technology. The finalist team is made up of Dr Peter Fitzgerald, managing director, John Lamont, R&D manager, and Ivan McConnell, divisional R&D manager of biochip research, manufacture and instrument design. The Randox vision is to ‘develop a complete diagnostic system that will provide more accurate patient diagnosis and enable selection of the most appropriate therapeutic treatment on an individual patient basis.’

Innovation

Picture of a 9 chip carrierEvidence® enables the simultaneous detection and quantification of multiple proteins and other compounds associated with disease states in clinical samples on a single biochip. This is the first commercially available protein biochip and assay system. This system replaces multiple reaction wells with a single technology platform, individual tests with multi-test panels and sample re-runs with a unique concept of retrospective reporting.

The biochip (similar to a silicon chip) consists of a 1cm2 substrate on which discrete test regions have been constructed. Each test region consists of different antibodies or reactive species for each assay. The biochip carrier, a transport vehicle for biochips, is a square object with nine separate reaction wells. A biochip is secured in the base of each well and this is used as a reaction chamber for the patient sample assay.

The biochip assays are based on standard immunoassay techniques. In the test panels, antibodies are attached to the biochip surface, to which any analytes in the patient sample bind. Chemiluminescence (production of light via a chemical reaction) is used to determine the level of analyte present in a sample. The light emission from the test regions is detected and quantified using a CCD (charge coupled device) camera and the image is then processed using dedicated software designed by Randox Laboratories.

This fully automated analyser performs a great number and variety of diagnostic tests per patient sample simultaneously, thereby requiring fewer samples than conventional methods. It is possible to test for up to 25 different proteins on a single biochip. This gives much more information from a single sample than is currently available. This capacity also reduces the need for repeat samples from the same patient as the results of the analysis carried out.

It also allows the possibility of discovering relationships between different proteins involved in disease, thus improving the accuracy of diagnosis. 

Commercial Applications

The technology is applicable to a wide range of diagnostic parameters including thyroid hormones, fertility hormones, cancer markers, cardiac markers, allergy testing, infectious diseases, blood grouping, drugs of abuse, antibiotic drug residues and anabolic steroids. At present, more than 3500 tests per hour can be analysed on drug residues, thyroid, fertility, tumour, cardiac, allergens and others, whereas conventional methods can only perform just over 200 tests in an hour, allowing speedier processing of tests for more patients a great cost saving for both public and private healthcare facilities.

This technology can also be used for drug testing of athletes, clinical trials to test the safety and side effects of new drugs and many other applications. The aim in the future is to have a personalized preventative medical system where the individuals health can be monitored to detect any early signs of disease.

Randox has successfully negotiated contracts worldwide with private laboratories and public hospitals to the value of 25 million over the next three years. Evidence is already in use in China, the US, Austria, Greece and Turkey. Within five years worldwide sales are predicted to top 300 million.

For further details look at their web-site at www.randox.com

 

 

Updated July 2012

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