Healthcare professionals can now conduct immediate comprehensive general health diagnosis at the point-of-care and begin triage faster and easier
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.
Media Inquiries: Investor Relations Inquiries:
FischerHealth Lytham Partners, LLC
Michelle McAdam, Roger Fischer Joe Dorame
310-577-7870 x133 602-889-9700
|SOURCE Abaxis, Inc.|
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