FDA Clearance

RNS Number:1282E
BBI Holdings PLC
19 September 2007

BBI HOLDINGS PLC

FDA clearance for Verax test

BBI Holdings Plc ('BBI'), the AIM listed developer and manufacturer of rapid
result diagnostic tests and reagents for the diagnostic industry, announces that
Verax Biomedical Inc.'s 510(k) application for its Platelet PGD test has been
accepted by the U.S. Food and Drug Administration (FDA).

The FDA clearance of the test permits Verax to market the device. With an
estimated 10 million platelet units transfused each year into patients in North
America, Europe and Asia, Verax anticipates a strong worldwide demand for their
Platelet PGD Test.

In March 2006 BBI signed a 10-year contract with Verax to provide gold colloid
and manufacturing services for the test and Abbott Diagnostics have signed a
worldwide exclusive agreement to market and distribute the product.

The Verax PGD Platelet test, which had been developed in conjunction with BBI,
is a rapid, easy-to-use disposable test which can detect bacterial contamination
of blood platelets in less than 30 minutes. Bacterial contaminants in platelets
and red blood cells represent the greatest infectious risk in transfusion
medicine today, with over 17 million patients receiving 60 million units of
blood annually in the US, Europe and Asia at risk of contamination.

No practical methods are currently available to address the threat of bacterial
contaminants in blood and the Verax PGD Platelet test is the only point of care
test at the clinical trial stage. A method for limiting and detecting bacterial
contamination in platelet components has been required by the blood banking
industry since March 2004.

Commenting, Julian Baines CEO of BBI said:

"The FDA clearance is an important milestone for the Platelet PGD Test which BBI
has been developing with Verax since August 2002.

"Although initial volumes are expected to be modest, as the test is introduced
to the market, it is clear that Verax believe that the potential market for this
product in substantial. BBI is well placed in terms of our 10-year manufacturing
contract and our capacity to produce large volumes of tests to benefit
enormously from demand for this product."

ENDS

For further information please contact:

BBI Holdings plc Landsbanki Securities (UK) Ltd Parkgreen Communications Ltd

Julian Baines, CEO Sindre Ottesen Paul McManus
Tel: 029 2074 7232 Fred Walsh Tel: 020 7479 7933
Tel: 020 7426 9000 Mob. 07980 541 893
www.bbigold.com Email: paul.mcmanus@parkgreenmedia.com

Background notes:

About BBI Holdings PLC (AIM: BBI):

BBI is a leading supplier of products and services to the global diagnostic and
healthcare industries. BBI floated on AIM on 28 April 2004 at 47p.

BBI operates in three core areas:

1. BBInternational (diagnostics)

Incorporating:

British Biocell, Cardiff, UK

BBI Dundee (formerly Alchemy Laboratories), Dundee, UK

BBI Research, Madison, Wisconsin, USA

Qnostics, Glasgow, UK

BBI manufactures superior quality gold reagents which are used to bind with
specific antibodies or antigens, which are used in diagnostic tests to provide a
positive or negative visual signal. BBI also provides contract product
development services for leading diagnostic companies using its expertise to
develop rapid result diagnostic tests. BBI also manufactures rapid result
diagnostic tests in the UK and the US. Rapid test manufacture involves placing
conjugate onto a pad or strip and enclosing this within a preformed plastic
package 'housing' designed to the customer's specifications. BBI's Qnostics
division supplies molecular quality control reagents to the global market place.

www.bbigold.com

2. BBI Enzymes

Incorporating:

Biozyme, Blaenavon, UK

Seravac, Cape Town, S Africa.

Theratase was acquired by BBI in May 2007 to form BBI's enzyme division. Biozyme
and Seravac are leading manufacturers and suppliers of high quality specialist
natural enzymes to the medical diagnostics industry. Enzymes are proteins which
drive complex reactions that occur in all living organisms. Their high
specificity and dramatic catalytic activity has been exploited within the
diagnostic industry.

www.biozyme.com

www.seravac.com

3. BBI Healthcare (diabetes)

Brands:

GlucoGel

SensoCard Plus

GlucoTabs

In April 2004 BBI acquired Hypostop (now renamed GlucoGel in the UK). GlucoGel
is an easy to use dextrose gel which is included in the National Institute for
Clinical Excellence's (NICE) treatment guideline for hypoglycaemia. BBI
Healthcare was founded in April 2006 to manage the sales and marketing of
GlucoGel, and build a diabetes care product portfolio. In July 2006 BBI acquired
the UK's only talking blood glucose meter for the visually impaired called
SensoCard Plus. The acquisition gives BBI exclusive distribution rights for
within the UK, US, Canada and India.

www.bbihealthcare.com

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