Tepnel Receives FDA Approval

RNS Number:9273P
Tepnel Life Sciences PLC
10 August 2005

August 10th 2005

TEPNEL RECEIVES FDA 510(k) CLEARANCE FOR DNA TYPING SYSTEM

Tepnel Life Sciences PLC (AIM: TED), the UK-based international Research
Products & Services and Molecular Diagnostics group, announces today that its
Lifecodes DNA typing kits for HLA-A, HLA-B, HLA-C, HLA-DQB and HLA-DRB have
received 510(k) marketing clearance from the U.S. Food and Drug Administration
(FDA) for use with the Luminex 100 instrument system. Lifecodes is a multi-test
system designed for use in laboratories serving the solid organ and bone marrow
transplantation field. This approval follows the FDA clearance received in July
2004 for Tepnel's antibody products to be marketed for In Vitro Diagnostic (IVD)
use.

The worldwide market for transplant diagnostics is estimated to be about $150
million with the U.S.A. representing approximately $60 million. Additionally, a
new application in this field is post-transplant monitoring, which has only
recently been adopted by the leading transplant centres and is growing at an
estimated rate of nearly 20% per annum.

The competitive advantage of these kits with the Luminex 100 instrument system
is that they are highly automated, minimising the chance of sample loss or
contamination. Labour and consumables costs are dramatically reduced compared to
manual tests and the throughput is the highest of any commercial assay.

Ben Matzilevich, Tepnel CEO, commented: "We are delighted to report this 510(k)
marketing clearance which will enable us to commence marketing these kits for
IVD use in the U.S.A. Since 2001 these kits have been marketed for research use
only and we will now be able to access the world's largest market for DNA
typing, following our entry into Europe with CE marked DNA and antibody kits for
IVD use in 2004. We envisage that these kits will make a substantial
contribution to Tepnel's Lifecodes business within the next 12 to 18 months. "

About Tepnel

Tepnel Life Sciences (TLS) is a UK based international biotechnology company.
The Company has laboratories, manufacturing and operations in the USA, UK and
France with 175 employees. TLS 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. TLS focuses on these
niche opportunities with internally developed products, patents, expertise and
know-how as well as strategic acquisitions, to develop a leadership position
within these defined market segments.

Enquiries:

Ben Matzilevich, Chief Executive Officer, Tepnel Life Sciences plc 0161 946 2200
Gron Ffoulkes-Davies, Finance Director, Tepnel Life Sciences plc 0161 946 2200
Mark Percy, Seymour Pierce Limited 0207 107 8000
Richard Anderson, De Facto Communications Ltd 0207 940 1000

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