Abaxis' new CRP assay receives FDA marketing clearance

Jan 21 2010

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.