FDA Clearance

RNS Number:9217E
BBI Holdings PLC
02 October 2007


                                BBI HOLDINGS PLC


           BBI's HSV- 2 Point of Care test gains FDA 510(k) Clearance


BBI Holdings Plc ('BBI'), the AIM listed developer of rapid result diagnostic
tests and reagents for the diagnostic industry, announces that the HSV-2
(genital herpes) point of care test developed alongside Focus Diagnostics Inc.
(Focus) has received FDA 510(k) clearance.

The clearance means that the test, which has been developed on BBI's 'POCkit'
platform, can now be commercialised in the U.S.A. Focus, which is now part of
Quest Diagnostics Inc., has exclusive distribution rights for the product in the
United States and Europe, and BBI has the exclusive rights for the Rest of the
World.

It is estimated that over 60 million adults in the U.S. are infected with HSV-2,
and because HSV-2 is poorly recognised and infrequently diagnosed, up to 90% of
patients do not know they have it. The Foundation for AIDS Research estimates
that genital herpes more than triples a person's risk of acquiring HIV. The
availability of the type specific POCkit HSV-2 point of care test will allow for
immediate testing of at-risk patients in the doctor's office, and ensure that
treatment to clear up the condition can commence immediately.

The highly sensitive test uses patented technology exclusively licensed to BBI
to eliminate the common HSV-1 'cold sore' signal for accurate diagnosis of the
more serious HSV-2 virus. BBI is the exclusive manufacturer of this product and
is currently evaluating commercialisation for the rest of the world market.


Commenting on the approval, Julian Baines CEO of BBI said:

"Having invested financially and spent a significant amount of time in the
development of this product, we are very pleased that the FDA clearance has come
through. We have known the strong technical performance of this test since the
clinical trials were completed, and the regulatory clearance will enable BBI and
our partners to finally take the product to market. This is very timely given
the increased interest in HSV-2 screening on a global basis, and we expect a
positive response to the test within the U.S. market. It is pleasing to note
that, having received this FDA 510(k) clearance, we have already achieved two
out of the three key internal targets that we set BBI for the second half of
this financial year."


ENDS




For further information please contact:


BBI Holdings plc         Cenkos Securities plc         Parkgreen Communications Ltd

Julian Baines, CEO       Stephen Keys                  Paul McManus
Tel: [phone]       Tel: [phone]            Tel: [phone]
                                                       Mob. [phone]
www.bbigold.com                                        Email: [e-mail]





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




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