UNION CITY, Calif., Jan. 21 /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 510K marketing clearance of the new C-Reactive Protein (CRP) assay when used by healthcare professionals in conjunction with the Piccolo Xpress™ point-of-care analyzer. As a result of this new FDA 510K approval, U.S. healthcare professionals can now conduct on-site chemistry analysis in less than 12 minutes for many types of conditions including infections, inflammatory diseases, tissue injury and some neoplastic processes.
CRP is widely used as an indicator of inflammation or infection and will initially be made available to the U.S. market on an acute care panel called MetLyte Plus CRP. The most common use of the CRP assay is by Rheumatologists in the detection and treatment of Rheumatoid Arthritis, although the test has utility in the detection and treatment of other afflictions including Colon Cancer, Non Hodgkin's Lymphoma, fever from bacterial infections, Atrial fibrillation and Osteomyelitis. Abaxis is also investigating other configurations of tests along with CRP that may have additional utility to Physicians at the point-of-care.
"With the addition of the CRP assay, Abaxis continues to add valuable specialty tests to its already broad general chemistry menu offering," said Clint Severson, chairman and chief executive officer of Abaxis, Inc. "Our technology has the ability to perform a wide variety of tests, and our rich R&D pipeline continues to accelerate the Piccolo platform far beyond any other point-of-care device. As the Piccolo test menu expands, Physicians will be able to do more on-site, leading to improvements in patient care, practice efficiency and profitability."
The CRP assay has been in use outside the United States, in Europe and Asia Pacific for over 6 months. In these regions, CRP is widely used as a standard test in general health screenings, and as part of routine clinical practice. Usage of the test continues to grow as Physicians learn about its availability and ease of use at the point-of-care.
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 26 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.
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SOURCE Abaxis, Inc.