Abaxis Announces First Ever CLIA-Waived Comprehensive Metabolic Panel
08 11월 2007 - 9:30PM
PR Newswire (US)
Healthcare professionals can now conduct immediate comprehensive
general health diagnosis at the point-of-care and begin triage
faster and easier than ever. UNION CITY, Calif., Nov. 8
/PRNewswire-FirstCall/ -- Abaxis, Inc. (NASDAQ:ABAX), a medical
products company manufacturing point-of-care blood analysis
systems, announced today that the U.S. Food and Drug Administration
(FDA) has granted waived status under CLIA regulations for 4
additional analytes, that subsequently allows the waived status of
3 additional complete chemistry panels, including the Comprehensive
Metabolic Panel, Basic Metabolic Panel and Electrolyte Panel. With
these new CLIA waived panels, the healthcare community can now
conduct lab-accurate comprehensive health screenings in nearly any
environment with ease, efficiency and speed under a simple
certificate of waiver. The 4 analytes - Chloride (Cl-), Potassium
(K+), Sodium (Na+), and Total Carbon Dioxide (tCO2) - were granted
waived status by the FDA when used in conjunction with the
Piccolo(R) and Piccolo Xpress(TM) point-of-care analyzers for the
medical market. "With these important CLIA waivers, the healthcare
community has the new and unique capability to conduct immediate
comprehensive health assessments at the point-of-care and begin
patient triage with a high degree of accuracy and certainty - all
without the burden of conforming to complex laboratory
requirements," said Dr. Steven Kazmierczak, Professor of Pathology
at Oregon Health & Science University. "The potential impact of
these FDA waivers is significant for the healthcare industry. The 9
CLIA waived panels now on the Abaxis menu represent over 90% of all
general chemistries ordered in the U.S." said Clint Severson,
Chairman, President and CEO of Abaxis. "By removing the barriers
associated with moderately complex chemistry analysis, a host of
non-traditional healthcare environments such as retail clinics,
mobile clinics and home healthcare professionals can now conduct
comprehensive health screenings at the point of care." Dr. Dennis
Bleile, Director of Assay Performance and Compliance for Abaxis,
Inc. said, "The data collected to achieve CLIA waiver for 20 of our
test methods has validated our belief that any medical practice
using our Piccolo analyzers can achieve lab-accurate results at the
point of care. The Piccolo analyzer and the complement of available
CLIA waived diagnostic tests now broaden the capabilities for a
wider variety of healthcare professionals to make critical, on-site
patient triage recommendations without the expense, resources and
documentation required for a moderately complex laboratory." The
Abaxis CLIA waived menu of health panels now includes: --
Comprehensive Metabolic Panel -- Basic Metabolic Panel --
Electrolyte Panel -- Kidney Check -- Lipid Panel -- Lipid Panel
Plus -- Liver Panel Plus -- General Chemistry 6 -- General
Chemistry 13 About Abaxis, Inc. 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 13 tests on
veterinary patients and 14 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 may include 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 related to the protection of the company's
intellectual property or claims of infringement of intellectual
property asserted by third parties, risks involved in carrying of
inventory, risks associated with the ability to attract, train and
retain competent sales personnel, competition 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 statement
was made. Abaxis does not undertake and specifically disclaims any
obligation to update any forward-looking statements. Contact: Clint
Severson Rick Betts Chairman, President and CEO Director of
Marketing Abaxis, Inc. Abaxis, Inc. 510-675-6500 510-675-6544 Media
Inquiries: Investor Relations Inquiries: FischerHealth Lytham
Partners, LLC Michelle McAdam, Roger Fischer Joe Dorame
310-577-7870 x133 602-889-9700 DATASOURCE: Abaxis, Inc. CONTACT:
Clint Severson, Chairman, President and CEO, +1-510-675-6500, or
Rick Betts, Director of Marketing, +1-510-675-6544, both of Abaxis,
Inc.; Media Inquiries: Michelle McAdam or Roger Fischer, both of
FischerHealth, +1- 310-577-7870 ext. 133; or Investor Relations
Inquiries: Joe Dorame of Lytham Partners, LLC, +1-602-889-9700 Web
site:
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Abaxis, Inc. (delisted) (NASDAQ:ABAX)
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Abaxis, Inc. (delisted) (NASDAQ:ABAX)
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