US Patent Approval
October 08 2007 - 3:02AM
RNS Non-Regulatory
BBI Holdings PLC
08 October 2007
8 October 2007
BBI HOLDINGS PLC
US Patent Approval for New Lateral Flow Point of Care Technology
BBI Holdings Plc ('BBI'), the AIM listed developer and manufacturer of rapid
result diagnostic tests and reagents for the diagnostic industry, announces that
the United States Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for a U.S. patent for a lateral flow technology that is exclusively
licensed to BBI for its HSV-2 testing platform. BBI also has access to the
technology to develop assays using antigens other than HSV.
The Notice of Allowance, which relates to an analyte assay device with a
pre-absorbing zone, is the official notification that the USPTO finds the
claimed subject matter allowable and intends to issue the patent pending payment
of the issue fee. A European Patent has previously been granted, for which BBI
has exclusive rights.
BBI has applied the technology to its 'POCkit' HSV-2 platform which it announced
on Monday has received FDA 510(k) clearance in the U.S. The assay has been
developed in collaboration with Focus Diagnostics Inc. ('Focus'), the U.S. based
provider of type-specific laboratory HSV diagnostic products that is now part of
Quest Diagnostics Inc. Focus has exclusive distribution rights for the product
in the United States and Europe, and BBI has the exclusive rights for the rest
of world along with exclusive global manufacturing rights.
It is estimated that over 60 million adults in the U.S. are infected with HSV-2
and, because HSV is poorly recognised and infrequently diagnosed, up to 90% do
not know they have it. Furthermore, the Foundation for AIDS Research estimates
that genital herpes more than triples a person's risk of acquiring HIV,
indicating a real market need for rapid accurate diagnostics within the doctor's
surgery.
Commenting, Julian Baines CEO of BBI said:
"This U.S. patent will further strengthen BBI's overall IP portfolio and
demonstrates our core expertise in developing a wide range of point of care
products. This comes at a time when the FDA has cleared the test for
commercialisation in the U.S., and will enable us to take the product into the
U.S. market with confidence that the IP rights cannot be challenged or the
technology imitated.
"Our POCkit(R) kit is a well established development platform that reduces
lateral flow assay development time by up to six months, and we expect to see
further similar collaborations and a broader development of our IP portfolio
over time".
ENDS
For further information please contact:
BBI Holdings plc Cenkos Securities plc Parkgreen Communications Ltd
Julian Baines, CEO Stephen Keys Paul McManus
Tel: 029 2074 7232 Tel: 020 7397 8900 Tel: 020 7479 7933
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
END
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