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MacRobert Award
2003 Winner
Randox Laboratories Ltd
 Randox
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
 Evidence®
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
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