Bio-Rad and Axis-Shield Announce FDA Clearance
13 October 2010 - 5:00PM
UK Regulatory
TIDMASD
RNS Number : 2798U
Axis-Shield PLC
13 October 2010
Bio-Rad and Axis-Shield Announce FDA Clearance and U.S. launch of an Anti-CCP
Test for Rheumatoid Arthritis for Bio-Rad's BioPlex 2200 System
Hercules, California, and Dundee, Scotland - October 13, 2010- Bio-Rad
Laboratories, Inc. (NYSE: BIO and BIOb), a multinational manufacturer and
distributor of life science research and clinical diagnostics products, and
Axis-Shield plc (LSE:ASD, OSE:ASD), an international and innovative in-vitro
diagnostics company, today announced the U.S. Food and Drug Administration (FDA)
clearance and U.S. launch of Bio-Rad's BioPlex 2200 Anti-CCP test for the early
detection of rheumatoid arthritis. The assay, which runs on Bio-Rad's BioPlex
2200 system, measures anti-CCP (anti-cyclic citrullinated peptide antibodies), a
novel marker that has been shown to have superior specificity in the diagnosis
of rheumatoid arthritis. The BioPlex 2200 Anti-CCP assay is based on
Axis-Shield's proprietary anti-CCP technology and was launched in territories
outside the U.S. earlier in 2010.
"We are pleased to receive FDA clearance of our BioPlex 2200 anti-CCP assay as
it allows us to expand our presence in the U.S. by offering a more compelling
menu for infectious disease serology and autoimmune testing laboratories," said
John Goetz, Bio-Rad Vice President and Group Manager of Clinical Diagnostics.
"We believe the recent recommendation by the American College of Rheumatology
and the European League Against Rheumatism to include anti-CCP in the definitive
diagnosis of rheumatoid arthritis will further establish the growth of this
important marker in autoimmune diagnostics."
"FDA market clearance for the anti-CCP test on Bio-Rad's novel BioPlex 2200
system represents an important milestone in the commercialization of the
anti-CCP marker for rheumatoid arthritis," said Ian Gilham, Axis-Shield's Chief
Executive Officer. "Test availability on this versatile analyzer represents the
first time that anti-CCP has been offered on a multiplex autoimmune platform,
and we believe this will encourage market expansion as the autoimmune nature of
many conditions becomes increasingly recognized."
The BioPlex 2200 system is the first and only fully-automated, random access
multiplex testing system and provides clinical laboratories with the capability
to rapidly process or "multiplex" multiple individual tests that are
traditionally processed separately. The BioPlex 2200 system conserves patient
sample volume, consolidates workstations, and simplifies workflow.
-Ends-
For more information contact:
Bio-Rad Laboratories, Inc.Axis-Shield plc
Tina Cuccia, Corporate Communications Ian Gilham, Chief
Executive Officer
Tel: +4 510 724 7000 Ronny
Hermansen, Financial Director
investor_relations@bio-rad.com Tel: +44 (0)
203 178 7849
+-------------------------------------+-------------------------------------+
| | M:Communications (for Axis-Shield) |
+-------------------------------------+-------------------------------------+
| | Mary-Jane Elliott / Emma Thompson |
+-------------------------------------+-------------------------------------+
| | Tel: +44 (0) 207 920 2330 |
+-------------------------------------+-------------------------------------+
| | Axisshield@mcomgroup.com |
+-------------------------------------+-------------------------------------+
About Axis-Shield
Axis-Shield is an international and innovative in vitro diagnostics company,
headquartered in Dundee with R&D and manufacturing bases in Dundee and Oslo. The
Group specialises in the supply of instruments and tests for the rapidly growing
physician's office testing market and the development, manufacture and marketing
of innovative proprietary diagnostics kits in areas of clinical need, including
cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes.
For more information on Axis-Shield, please refer to www.axis-shield.com.
About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) has remained at the center of
scientific discovery for more than 50 years, manufacturing and distributing a
broad range of products for the life science research and clinical diagnostic
markets. The company is renowned worldwide among hospitals, universities, major
research institutions, as well as biotechnology and pharmaceutical companies for
its commitment to quality and customer service. Founded in 1952, Bio-Rad is
headquartered in Hercules, California, and serves more than 85,000 research and
industry customers worldwide through its global network of operations. The
company employs over 6,800 people globally and had revenues of nearly $1.8
billion in 2009. For more information, please visit www.bio-rad.com.
This release contains certain forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and Section 21E of the
Securities Exchange Act of 1934. Forward-looking statements generally can be
identified by the use of forward-looking terminology such as, "believe,"
"expect," "may," "will," "intend," "estimate," "continue," or similar
expressions or the negative of those terms or expressions. Such statements
involve risks and uncertainties, which could cause actual results to vary
materially from those expressed in or indicated by the forward-looking
statements. For further information regarding the Company's risks and
uncertainties, please refer to the "Risk Factors" in the Company's public
reports filed with the Securities and Exchange Commission, including the
Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K. The Company cautions you not to place undue
reliance on forward-looking statements, which reflect an analysis only and speak
only as of the date hereof. Bio-Rad Laboratories, Inc., disclaims any obligation
to update these forward-looking statements.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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