UNION CITY, Calif.,
March 28, 2014 /PRNewswire/ --
Abaxis, Inc. (NasdaqGS: ABAX), a medical products company
manufacturing point-of-care blood analysis systems, today announced
the Food and Drug Administration granted CLIA waived status for
capillary draw for CHOL, HDL and TRIG. Combined with existing
CLIA waived tests for liver diagnostics using capillary samples,
Abaxis now has two complete Lipid Panels which can be used by
healthcare professionals to diagnose, treat and monitor
hyperlipidemia patients using a sample obtained from either venous
blood or a capillary draw.
Obtaining CLIA waived status for capillary sampling is an
important step in bringing comprehensive care closer to the
patients in the U.S. With the new cholesterol guidelines
released by the American Heart Association last November, which
reduced statin medication thresholds, healthcare professionals,
health screeners, pharmacy/retail health chains and occupational
health organizations can have lab-accurate lipid, liver, glucose
and triglyceride diagnostic results in 12 minutes without the need
for a certified phlebotomist. Now the estimated 13 million
more Americans who will be eligible for cholesterol-lowering
medications can be assured of quick and accurate lab results to
help diagnose and monitor their treatment progress.
"The FDA's granting of our CLIA waiver applications for
capillary-obtained lipids is an important step to improving the
healthcare system," said Clint
Severson, chairman and chief executive officer of Abaxis,
Inc. "We all know that high cholesterol can lead to heart disease
and other serious afflictions. The key to lower healthcare
costs is catching these problems early, before the real and
expensive damage is done. Now healthcare professionals can do
a simple fingerstick to diagnose, treat and monitor hyperlipidemia
patients with greater ease than ever."
"Abaxis is also now the only company that provides a capillary
or venous CLIA waived Lipid and Liver panel to monitor statin
medications at the point-of-care," Severson added. "Cholestech took
their liver function tests off the market last year, leaving the
Piccolo as the sole trusted provider of on-site statin-monitoring
blood chemistry diagnostics."
With the Piccolo delivering lab-accurate blood chemistry results
on-site in minutes, physicians can make confident treatment
decisions while the patient is in their office, thereby increasing
the speed and quality of care while reducing the unreimbursed time
spent preparing labs and relaying patient results. The
capability to diagnose and treat in one visit can have a dramatic
impact on practice throughput. Clinics can see more patients
each day by eliminating unnecessary call-backs and follow up visits
due to standard 24-hour lab turnaround. And, by having
immediate results while they're in front of the physician, patients
can experience the real impact of their compliance or
non-compliance to treatment regimens, which can improve outcomes
and reduce hospitalizations.
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 31 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.
The Piccolo Xpress and reagents are sold exclusively through
Abbott Point of Care in the United
States. For more information please visit
http://www.piccoloxpress.com/distributors/
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
|
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510-675-6500
|
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SOURCE Abaxis, Inc.