Glycosal to be used by US Govt.Health Agency -Diabetes trial
PROVALIS PLC 2000-11-23 ASX-SIGNAL-G
HOMEX - Perth +++++++++++++++++++++++++
Provalis Diagnostics and its US distributor Bio-Rad are pleased to
announce that the Glycosal(TM) point-of-care test will be used in one
of the most extensive, long term, diabetes care trials ever to be
carried out. Glycosal(TM) is a Point-of-Care diagnostic product for
measuring the long term level of glucose (glycated haemoglobin or
HbA1c) in the blood of diabetics.
This landmark clinical trial studying the treatment of diabetes has
been named the 'Action to Control Cardiovascular Risk in Diabetes'
(ACCORD) trial. The National Heart, Lung and Blood Institute (a
division of the US National Institute of Health) is sponsoring the
ACCORD trial. It will last for 8 years and involve up to 10,000
patients, and will involve Glycosal(TM) being used to test each
patient monthly.
The overall goal of the ACCORD trial is to address the challenge of
reducing the rate of cardiovascular disease in patients with Type 2
diabetes. Glycaemic control, as measured by blood glucose and HbA1c
levels, is one of the three cardiovascular disease risk factors that
will be assessed during the trial. HbA1c testing will be done at
approximately 60 clinical sites in the United States and Canada.
John Curtis, Managing Director of Provalis Diagnostics said "We are
delighted to be part of such an important and prestigious trial. The
decision by the US government to use Glycosal(TM), so soon after
regulatory approval (510k) of it was granted, represents a
confirmation of confidence in the quality of our product and the
ability of Provalis to supply their extensive needs over the next
eight years.
Phil Gould, CEO of Provalis added, "The awarding of this contract
shows great confidence in our product and will generate significant
additional secure business for the product over an extended period.
This contract supports the continued move of our Medical Diagnostic
division towards profitability, and justifies the extensive R&D
activity and resource used in the development of the product."
Commenting on the award of this US government contract John Hertia,
New Business Development Manager of Bio-Rad Laboratories Inc, said
"We are pleased to be part of the ACCORD trial. Starting from the
land mark Diabetes Control and Complications (DCCT) trial, Bio-Rad
has always been actively involved in diabetes clinical research,
providing research teams with high-performance systems for HbA1c
measurement. Provalis' Glycosal(TM) product, in the Bio-Rad format
Micromat II, was selected over other systems for its technical
performance and ease of use. We look forward to working with the NIH
and Provalis on supplying the product for this important trial".
Provalis' Internet Website: provalis.com
For further information:-
Dr Phil Gould, Provalis plc Tel: 01244 833 463
Mr John Curtis, Provalis Diagnostics Limited Tel: 01244 833 527
Lisa Baderoon, Buchanan Communications Tel: 020 7466 5000
DIABETES
Diabetes is a chronic disease that has no cure and effects 5 to 10%
of the population. The disease is on the increase and is reaching
epidemic proportions in the Western World. A recent study in the
United States showed a massive 33% increase in the incidence of the
disease over an eight-year period from 1990 to 1998. This trend is
set to continue with an ageing and increasingly overweight
population. Diabetes leads to many serious complications, which
include blindness, amputations and kidney disease. However, one of
the most serious complications is an increase in the incidence of
coronary heart disease (heart attacks) and stroke.
ACCORD TRIAL
The ACCORD trial aims to tightly control the blood glucose (sugar),
blood pressure and cholesterol levels of diabetics, within normal
levels. It is expected that this will markedly decrease the incidence
of heart disease and lead to an improved quality of life for those
suffering from the disease.
The trial will monitor 10,000 patients over an 8 year period at
approximately 60 centres across the United States and Canada. The
Glycosal(TM) test will be used to monitor the glycated haemoglobin
(HbA1c) level of up 10,000 patients on a monthly basis, as part of
their clinical examination. It is intended that progress papers will
be published by the National Heart Lung and Blood Institute
throughout the period of the trial.
The ACCORD trial contract has been placed with Bio-Rad, one of the
two US distributors of Glycosal(TM), which is sold by Bio-Rad in the
US under the Micromat II brand name. Bio-Rad are the world's leading
suppliers of HbA1c tests with worldwide sales in excess of 30,000,000
tests in 1999.
The current $800m HbA1c market is set to increase dramatically over
the next few years as the number of Diabetics increase. The ACCORD
trial is a landmark event in the care and treatment of people with
Diabetes and follows on from the Diabetes Control and Complications
Trial (DCCT) and the UK Prospective Diabetes Study (UKPDS), which are
already having a major impact on the health and well-being of
diabetics. These trials have demonstrated that frequent HbA1c testing
offers a significant reduction in the long term costs of treating
diabetes which currently accounts for 10% of all Western Healthcare
costs." |
