Abaxis Receives FDA 510K Clearance for a New Clinical Assay, C-Reactive Protein
21 1월 2010 - 9:00PM
PR Newswire (US)
U.S. Healthcare Professionals Now Have Access to Important
Information on Inflammation, Infection and Tissue Injury at the
Point-of-care. UNION CITY, Calif., Jan. 21 /PRNewswire-FirstCall/
-- Abaxis, Inc. (NASDAQ:ABAX), a medical products company
manufacturing point-of-care blood analysis systems, today announced
that the U.S. Food and Drug Administration (FDA) has granted 510K
marketing clearance of the new C-Reactive Protein (CRP) assay when
used by healthcare professionals in conjunction with the Piccolo
Xpress(TM) point-of-care analyzer. As a result of this new FDA 510K
approval, U.S. healthcare professionals can now conduct on-site
chemistry analysis in less than 12 minutes for many types of
conditions including infections, inflammatory diseases, tissue
injury and some neoplastic processes. CRP is widely used as an
indicator of inflammation or infection and will initially be made
available to the U.S. market on an acute care panel called MetLyte
Plus CRP. The most common use of the CRP assay is by
Rheumatologists in the detection and treatment of Rheumatoid
Arthritis, although the test has utility in the detection and
treatment of other afflictions including Colon Cancer, Non
Hodgkin's Lymphoma, fever from bacterial infections, Atrial
fibrillation and Osteomyelitis. Abaxis is also investigating other
configurations of tests along with CRP that may have additional
utility to Physicians at the point-of-care. "With the addition of
the CRP assay, Abaxis continues to add valuable specialty tests to
its already broad general chemistry menu offering," said Clint
Severson, chairman and chief executive officer of Abaxis, Inc. "Our
technology has the ability to perform a wide variety of tests, and
our rich R&D pipeline continues to accelerate the Piccolo
platform far beyond any other point-of-care device. As the Piccolo
test menu expands, Physicians will be able to do more on-site,
leading to improvements in patient care, practice efficiency and
profitability." The CRP assay has been in use outside the United
States, in Europe and Asia Pacific for over 6 months. In these
regions, CRP is widely used as a standard test in general health
screenings, and as part of routine clinical practice. Usage of the
test continues to grow as Physicians learn about its availability
and ease of use at the point-of-care. About Abaxis Abaxis develops,
manufactures and markets portable blood analysis systems for use in
any veterinary or human patient-care setting to provide clinicians
with rapid blood constituent measurements. The system consists of a
compact, 5.1 kilogram (11.2 pounds), portable analyzer and a series
of single-use plastic discs, called reagent discs that contain all
the chemicals required to perform a panel of up to 14 tests on
veterinary patients and 26 tests on human patients. The system can
be operated with minimal training and performs multiple routine
tests on whole blood, serum or plasma samples. The system provides
test results in less than 12 minutes with the precision and
accuracy equivalent to a clinical laboratory analyzer. This press
release includes statements that constitute "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995 (the "Reform Act"). Abaxis claims the protection
of the safe-harbor for forward-looking statements contained in the
Reform Act. These forward-looking statements are often
characterized by the terms "may," "believes," "projects,"
"expects," "anticipates," or words of similar import, and do not
reflect historical facts. Specific forward-looking statements
contained in this press release or in our conference call may be
affected by risks and uncertainties, including, but not limited to,
those related to the market acceptance of the company's products
and the continuing development of its products, required United
States Food and Drug Administration clearance and other government
approvals, risks associated with manufacturing and distributing its
products on a commercial scale free of defects, risks related to
the introduction of new instruments manufactured by third parties,
risks associated with entering the human diagnostic market on a
larger scale, risks associated with liquidity concerns related to
our auction rate securities, risks related to the protection of the
company's intellectual property or claims of infringement of
intellectual property asserted by third parties, predictions
related to condition of the United States economy, risks involved
in carrying of inventory and other risks detailed from time to time
in Abaxis' periodic reports filed with the United States Securities
and Exchange Commission. Forward-looking statements speak only as
of the date the statements were made. Abaxis does not undertake and
specifically disclaims any obligation to update any forward-looking
statements. Contact: Clint Severson Lytham Partners, LLC Chief
Executive Officer Joe Dorame, Robert Blum and Joe Diaz Abaxis, Inc.
602-889-9700 510-675-6500 DATASOURCE: Abaxis, Inc. CONTACT: Clint
Severson, Chief Executive Officer of Abaxis, Inc., +1-510-675-6500;
or Joe Dorame, Robert Blum and Joe Diaz of Lytham Partners, LLC,
+1-602-889-9700 for Abaxis, Inc. Web Site: http://www.abaxis.com/
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