Tepnel Life Sciences PLC
  27 August 2008
   

    PRESS RELEASE
    Contacts:
    Carol Smith
    Group Marketing Communications Manager
    Tepnel Life Sciences
    Tel: +44 (0)161 946 2220 
    csmith@tepnel.co.uk

    or

    Mary Clark / Joey Whineray
    Capital MS&L
    Tel: +44 (0)207 307 5337
    Joanna.whineray@capitalmsl.com

    Tepnel Announces New DNA Test for Early Detection of Familial Hypercholesterolaemia  

    Elucigene FH20 Effectively Identifies Genetic Mutations to Support Rapid Implementation of New Clinical Practice Guidelines in the UK

    Manchester, UK, 27th August, 2008 -- Just ahead of the expected release of clinical practice guidelines on Familial
Hypercholesterolaemia (FH) by the influential National Institute for Clinical Excellence (NICE), Tepnel Life Sciences PLC (AIM: TED) today
announced the launch of a DNA test for the early detection of FH, a genetic condition that predisposes individuals to high blood cholesterol
levels and increased risk of cardiovascular disease.  The CE marked Elucigene FH20 kit, validated for in vitro diagnostic use, can rapidly
determine the 20 genetic mutations most commonly found in a UK based population, that are responsible for the disease.

    FH is a public health problem throughout the world with an estimated 10 million people affected, the majority of who will suffer an
adverse coronary event before they are 65 years old. A common genetic disorder, the potentially lethal condition occurs in 1 of 500 people
in Europe and North America. In the UK it is estimated that up to 110,000 people are affected with FH and 75% of these cases are
undiagnosed.

    The NICE consultation on a draft of guidelines for use by the National Health Service (NHS) in England and Wales is now being finalized
with anticipated publication for August, 2008. NICE is expected to recommend that all FH patients are offered a DNA test with subsequent
cascade screening to be performed where the mutation is identified in a patient.

    In a recent UK pilot study the test identified a 52% mutation detection rate in a sample of 110 FH heterozygous patients.  "The study
findings validate Elucigene FH20 as a valuable component for future FH screening programs in the UK, providing a cost-efficient and simple
method for confirming a person has inherited this deadly condition," said Ben Matzilevich, Tepnel's Chief Executive Officer. "For effective
treatment, early identification of persons with FH is essential and FH20 offers the NHS the right tool at the right time to implement the
new clinical practice guidelines." 

    Currently late-stage clinical indications that suggest a patient is affected with FH are increased serum cholesterol concentration,
tendon xanthomas and premature coronary heart disease. Treatment with statins to lower cholesterol levels is effective, but preventative
treatment requires early diagnosis.  Pre-symptomatic identification of FH individuals can ensure the health risks of high cholesterol are
minimised through appropriate modifications to diet and lifestyle.

    Early detection requires identification of genetic mutations of the low-density lipoprotein receptor (LDLR) gene, the apoloiprotein
B-100 (Apo B) gene or the proprotein converatse subtilisin/kexin type 9 (PCSK9) gene which are the cause of FH. Unlike other genetic
diseases such as cystic fibrosis, where an affected patient must inherit two copies of the mutated gene, FH has an autosomal dominant
pattern of inheritance and requires the affected patient to carry only one copy of the mutated gene.

    While such DNA analysis and mutation detection is crucial for the definitive diagnosis of FH, the testing can be tedious and expensive
due to the extremely heterogeneous nature of the LDLR gene.

    Following the confirmation of mutation status of an FH patient using the rapid and cost-effective Elucigene FH20 assay, the new Tepnel
test can be used to detect other previously undiagnosed family members with FH through cascade screening programs.

    The Elucigene FH20 test is developed and manufactured within quality systems accredited to ISO9001 and ISO13485 and complies with the
European Community Directive 98/79/EC. The test is not for use in diagnostic procedures in the USA. 

    About Tepnel Life Sciences PLC
    Tepnel Life Sciences (AIM:TED) is a UK-based international life sciences products and services Group with two divisions, Molecular
Diagnostics and Research Products & Services. The Company has laboratories, manufacturing and operations in the USA, UK and France with over
200 employees. Tepnel provides test kits, reagents and services to two highly synergistic markets, these being Molecular Diagnostics and
Biomedical Research. The Company's strategy has been to identify high growth niche opportunities within these multi-billion pound markets.
Tepnel focuses on these niche operations with internally developed products, patents, expertise and know-how as well as strategic
acquisitions, to develop a leadership position within these defined market segments. For more information please visit www.tepnel.com.


This information is provided by RNS
The company news service from the London Stock Exchange
 
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