DATA Globaldata Plc

RNS Number:9377M
Provalis PLC
12 November 2001


For Immediate Release                                        12th November 2001


Provalis plc


        Provalis' GlycosalO Test Granted CLIA Waiver Status in the US

              and is cleared for Prescription Home Use in the US


Provalis plc (LSE: PRO and NASDAQ:PVLS), the integrated healthcare group
which, through its' Medical Diagnostics division, is a leading developer of
Point-of-Care tests for chronic and infectious diseases, is pleased to
announce that its' Glycosal diabetes test has been granted two important US
clearances.  Firstly, Glycosal has received clearance from the US Food and
Drug Administration (FDA) for Prescription Home Use, and secondly has been
granted CLIA waiver status.


Although Glycosal was previously cleared under the FDA 510(k) certification,
this only allowed use in the US by those doctor's office laboratories licensed
for "moderately complex" procedures, which constitute a minority of the
potential market.  These new clearances expand the market for the product, as
they mean that Glycosal can now be used by any doctor, nurse, pharmacist or
other healthcare professional at any location in the US, and can also be
prescribed by any doctor in the US for home use by any person with diabetes.
There are currently around 10 million people diagnosed with diabetes in the
US.



Prescription Home Use, and CLIA waiver status, are only granted to diagnostic
tests that have been proven to be sufficiently simple and accurate to use such
that erroneous results in the hands of a non-medical user are extremely
unlikely.  Few diagnostic products have ever been granted such status.
Glycosal is the first test for glycated haemoglobin (HbA1c), the universally
acknowledged indicator of long-term diabetes management, to receive full CLIA
waiver, Prescription Home Use and a full assay Quality Registration from the
US National Glycohaemoglobin Standardisation Program (NGSP).  This makes
Glycosal unique in the US market.



Commenting on these regulatory clearances, John Curtis, Managing Director of
Provalis Diagnostics said,  "This can be said to be the beginning of a new era
in diabetes management. Glycosal is the first diabetes management product to
be both certified to the exacting quality standards of the NGSP, and to have
been granted the clearances of Prescription Home Use and CLIA waiver, which
together certify the accuracy and simplicity of use of Glycosal. This opens
huge marketing opportunities in the US and demonstrates the level of
technology now being developed by Provalis".



Phil Gould, CEO of Provalis, added, "International regulatory approvals, NGSP
certification, and now CLIA waiver/Prescription Home Use status for Glycosal
have all been achieved in the last year.  This clears the test for use both by
a wider number of healthcare providers and also at home by patients with
diabetes.  This should now allow Glycosal's full potential in the US market -
the world's biggest market, estimated to be over one billion dollars per year
- to be realised".


For further information: -

Dr Phil Gould, Provalis plc, Tel:  01244 833463

Mr John Curtis, Provalis Diagnostics, Tel 01244 833542

Mr Lee Greenbury, Provalis plc, Tel:  01244 833402

Lisa Baderoon, Buchanan Communications, Tel:  020 7466 5000

M: 07721 413496

lisab@buchanan.uk.com




Provalis' Internet Website ; http://www.provalis.com



"Safe Harbor" Statement under the US Private Securities Litigation Reform Act
of 1995: Statements in this announcement that relate to future plans,
expectations, events, performances and the like are forward-looking statements
as defined in the US Private Securities Litigation Reform Act of 1995. Actual
results of events could differ materially from those described in the
forward-looking statements due to a variety of factors.  Such factors include,
among others: the success of the Group's research and development strategy;
uncertainties related to future trial results and the regulatory process; the
execution and success of collaborative agreements with third parties; the
impact of future laws, regulations and policies; the Group's intellectual
property position and the success of patent applications for its products and
technologies; stock market trends in the Group's sector; the Group's
dependence on key personnel; general business and economic conditions; and
other factors beyond the Group's control that may cause the Group's available
capital resources to be used more quickly than expected.  These and other
factors that could affect the Company's future results are more fully
described in its filings with the US Securities and Exchange Commission, in
particular the latest 20-F filing, copies of which are available from the
Company Secretary at the Company's registered address.





Notes To Editors



Provalis plc (LSE.PRO and NASDAQ.PVLS) is an integrated healthcare company
with three separate divisions:-

Healthcare - This division sells and markets branded, third party,
prescription medicines in the UK to GPs and hospitals through its own
regionally managed 42-man sales force. This division sells products in the
areas of gastroenterology, osteoporosis, migraine and osteoarthritis.

Medical Diagnostics - This division develops and sells medical diagnostic
products to world markets through distributors. The division has an
established business in diagnostic products for infectious diseases and has
recently launched the innovative products GlycosalTM and OsteosalTM in the
areas of diabetes and osteoporosis respectively.

Therapeutic R&D - This division develops a range of vaccine candidates for
infectious diseases through a network of research collaborators.



HbA1c



HbA1c is formed when haemoglobin in red blood cells binds glucose over the
cells' typical 90-day life span.  The quantitative measure of HbA1c has been
well established as a way to determine a patient's long term glycemic control
profile.  Unlike daily glucose monitoring, which provides a 'snapshot' of a
patient's glucose level at the time of testing, HbA1c provides an average
level over the previous 90 days and therefore indicates the long-term progress
of a diabetics disease and therapy management.



The American Diabetes Association (ADA) recommends that an HbA1c test be
performed every three-to-six months in all diabetes patients to determine how
well glucose has been controlled over that period of time.  The objectives are
to document blood glucose control at the initial assessment and to assess the
effectiveness of continuing care.  As a percentage of total blood haemoglobin,
the goal is to maintain an HbA1c level of 7% or lower.  Owing in part to
infrequent testing, the vast majority of diabetic patients have an HbA1c level
well in excess of the recommended 7% and are at a higher risk of developing
serious complications.



Glycosal



Providing accurate, real-time results outside of the laboratory, Glycosal is
suitable for point-of-care use in the physician office or diabetes clinic, as
well as for home testing by prescription.  The new device eliminates the need
for expensive laboratory instruments or tedious training procedures, removing
cost and complexity as barriers to decentralized HbA1c testing and monitoring.




Diabetes



Diabetes mellitus is a group of diseases characterized by high and fluctuating
levels of blood glucose.  It results from defects in insulin secretion,
insulin action, insulin resistance, or a combination of all three.  The
disease can lead to serious complications and premature death.  People with
diabetes can reduce such occurrences by maintaining proper blood glucose
levels through diet, exercise, medication and monitoring.  Type 1 and Type 2
diabetes are the most common forms.  Type 2 constitutes 90 percent to 95
percent of all cases; type 1 is an autoimmune disease in which the body makes
no insulin.  Type 2 diabetes is a metabolic disorder usually found in people
over the age of 30.  In the Unites States, it is recognised that nearly half
of all people with Type 2 diabetes remain undiagnosed.



Products used in testing patients with diabetes, which affects about 6 percent
of the world's population, have a compounded annual revenue growth rate of 15
percent, making them the fastest growing product segment in the in vitro
diagnostic (IVD) industry. Diabetes continues to reach epidemic proportions,
with nearly 150 million suffering worldwide (10 million Americans) with direct
and indirect costs in the United States alone of almost $100 billion annually.
  Indirect costs of $55 billion include disability, work loss and premature
mortality.  At about $3 billion per year, glucose-monitoring products
represent a large percentage of direct expenditures.



Diabetes can lead to complications including heart disease, stroke, high blood
pressure, blindness, nerve damage, kidney damage, periodontal disease,
amputation, congenital malformations incurred during pregnancy and diabetic
coma.  People with diabetes are more susceptible to many other illnesses, such
as pneumonia and influenza.  The risk of death from these illnesses and
complications is significantly greater than that for the general population.



According to the ADA, the death rate from diabetes has increased by  50
percent since 1985, while death rates from heart disease and stroke have been
declining.  Some population groups are at higher risk for diabetes as they
age.  The risk factors are family history, age, sex and ethnic background.
Obesity, unhealthy diet and a sedentary lifestyle increase disease prevalence.



510(k)



Before a new diagnostic test intended for Human use can be marketed in the
USA, it must first be reviewed by the Food and Drug Administration (FDA). A
510(k) is a submission made to the FDA which contains data which demonstrates
that the device to be marketed is safe, effective substantially equivalent to
a device which is already on the market. When the FDA are satisfied that the
510(k) submission proves that the new device is safe and effective, they issue
the device with a 510(k) number and give permission for the device to be
marketed in the US.



CLIA



In the USA, Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) Act in 1988, establishing quality standards for all laboratory testing
to ensure the accuracy and reliability of all laboratory tests, regardless of
where the test was performed. The CLIA regulations are based on the complexity
of the test method, and the more complex the test method, the more stringent
the requirements are for the laboratory which carries out the test. Test
methods are assessed by the FDA and the Health Care Financing Administration
(HCFA) and assigned one of three complexity ratings, namely, waived test,
moderately complex test and highly complex test. For a test to be designated
as waived it must be so simple and accurate as to render the likelihood of
obtaining an erroneous result as negligible. The majority of laboratories in
the US are only licensed to carry out tests which are waived.




                                     END

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