Abaxis Announces CLIA Waived Status
18 10월 2006 - 9:30PM
PR Newswire (US)
The Liver Panel Plus Is the Third Test Panel to Receive CLIA Waived
Status UNION CITY, Calif., Oct. 18 /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 six additional analytes --
Albumin (ALB), Alkaline Phosphatase (ALP), Amylase (AMY), Gamma
Glutamyltransferase (GGT), Total Bilirubin (Tbili), and Total
Protein (TP) -- when used in conjunction with the Piccolo
point-of-care analyzer for the medical market. The Company now has
a total of twelve analytes that have received the CLIA waived
status. "In obtaining CLIA waived status for these analytes, we can
now offer the Liver Panel Plus along with the Lipids Panel and
Lipids Plus Panel as waived tests to the medical market," commented
Clint Severson, chairman, president and CEO of Abaxis, Inc. "This
is another step forward in our goal of achieving waived status on
all of our medical test panels. Our next submission to the FDA for
waived status will consist of analytes from our General Chemistry
Panels 13 and 6." Dr. Dennis Bleile, director of assay performance
and compliance for Abaxis, Inc. said, "Many lipid lowering
medications and chemotherapeutic agents used in the out-patient
setting are metabolized by the liver. Since these drugs are often
toxic, liver function must be routinely monitored and drug dosage
adjusted accordingly. The ability for physicians to rapidly assess
liver function in an office or outpatient setting easily and
reliably is vital to providing the best treatment possible." "As we
continue to expand our ease of use features with the Piccolo, we
believe more physicians will realize the treatment benefits and
office efficiencies of on-site chemistry," stated Christopher
Bernard, VP of sales and marketing. About Abaxis, Inc. Abaxis
develops, manufactures and markets portable blood analysis systems
for use in any patient-care setting to provide clinicians with
rapid blood constituent measurements. The system consists of a
compact, 6.9 kilogram, portable analyzer and a series of 8-cm
diameter single-use plastic disks, called rotors or reagent discs
that contain all the reagents necessary to perform a fixed menu of
tests. The system can be operated with minimal training and perform
multiple tests on whole blood, serum or plasma samples. The system
provides test results in less than 14 minutes with the precision
and accuracy equivalent to a clinical laboratory. This press
release includes statements that constitute "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. ABAXIS claims the protection of the safe-harbor
for forward-looking statements contained in the Reform Act.
Specific forward-looking statements contained in this press release
include, but are not limited to, risks and uncertainties related to
the market acceptance of the Company's products and the continuing
development of its products, risks associated with manufacturing
and distributing its products on a commercial scale, risks
associated with entering the human diagnostic market on a larger
scale, risks involved in carrying of inventory, risks from
unexpected problems or delays in the Company's manufacturing
facility, risks associated with the ability to attract and retain
competent sales personnel, general market conditions, competition,
risks and uncertainties related to its ability to raise capital in
order to fund its operations 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 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, all
of Lytham Partners, LLC, +1-602-889-9700, for Abaxis, Inc.
Copyright
Abaxis, Inc. (delisted) (NASDAQ:ABAX)
과거 데이터 주식 차트
부터 7월(7) 2024 으로 8월(8) 2024
Abaxis, Inc. (delisted) (NASDAQ:ABAX)
과거 데이터 주식 차트
부터 8월(8) 2023 으로 8월(8) 2024