Abaxis Point-of-Care Test Panels Gain FDA CLIA-Waived Status
UNION CITY, Calif., Dec. 11 /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 waived status under CLIA regulations for two additional analytes, Creatine Kinase (CK) and Phosphorus (Phos), when used by healthcare professionals in conjunction with the Piccolo(R) and Piccolo Xpress(TM) point-of-care analyzers. As a result of their new waived status, healthcare professionals now have greater access to the Renal Function and MetLyte 8 Panels and can conduct this testing at the point-of-care under a simple certificate of waiver.
The Renal Function Panel is a standard panel mostly used for determination of renal function status. The MetLyte 8 is commonly used to assess a variety of metabolic conditions across several specialties, including pediatrics and cardiology. With the waiver of these two panels, 11 of the company's 13 medical test panels have CLIA-waived status.
"The waiver of these two panels bolsters our already comprehensive offering to healthcare professionals, enabling them to conduct important testing at the point-of-care in order to manage patients in real time," said Clint Severson, chairman and chief executive officer of Abaxis, Inc. "We believe rapid and accurate diagnostic testing can lead to improved patient care while reducing some of the administrative burden healthcare practices face on a daily basis."
The company's waived panels are utilized in a wide range of healthcare practices, including oncology, radiology, primary care, internal medicine, and urgent care clinics. The company's Comprehensive Metabolic Panel became the first ever test of its kind to gain waived status in November 2007. Comprehensive metabolic testing is one of the most commonly conducted tests in the United States.
"The Piccolo Xpress has enabled us to cost-effectively improve patient care while increasing practice efficiencies," said Dr. John A. Gastright, MD of West Ashley Family Medicine, Charleston, SC. "It has significantly reduced the administrative time previously spent on lab tests that were outsourced which in turn allow us to focus that time on patient care. Since we began using our POC analyzer, we are able to run CMP and Lipid panels for our patients in-house with results available to us in just minutes."
The Abaxis CLIA waived menu of medical test panels now includes:
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 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.
-- Renal Function -- MetLyte 8 -- Comprehensive Metabolic Panel -- Basic Metabolic Panel -- Electrolyte Panel -- Kidney Check -- Lipid Panel -- Lipid Panel Plus -- Liver Panel Plus -- General Chemistry 6 -- General Chemistry 13
SOURCE Abaxis, Inc.
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