ABAX Abaxis, Inc. (delisted)

ABAXIS Announces CLIA Waived Status UNION CITY, Calif., July 12 /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 has granted waived status under CLIA regulations for their lipids test panel when used in conjunction with their Piccolo point of care analyzer. "ABAXIS' achievement of CLIA waived status for this first panel submitted to the FDA is a crucial milestone in the company's development," comments Clint Severson, Chairman, President and CEO. "ABAXIS develops and supplies very technically sophisticated point of care products. Our analyzers are ultimately intended to be used by anyone in a near patient setting, whether at a local clinic or a remote site anywhere in the world. It is immensely gratifying for us that our technology, which has already gained broad-based commercial acceptance, is now recognized for its utility by the FDA." "This announcement signifies the first CRMLN certified lipid panel that is CLIA waived by petition," says Kenneth Aron, Ph.D., Vice President of Research and Development for ABAXIS. "This unequivocally shows that, in the case of lipids, our multi-analyte, panel-based technology is capable of delivering high accuracy results from multiple analytes in a point of care setting, all in a format accessible by untrained users." 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. DATASOURCE: ABAXIS, Inc. CONTACT: Clint Severson, Chief Executive Officer of ABAXIS, Inc., +1-510-675-6500; or Joe Dorame or Joe Diaz, both of RCG Capital Markets Group, +1-480-675-0400, for ABAXIS, Inc. Web site: http://www.abaxis.com/

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