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FDA Approves Abaxis’ New C-Reactive Protein Assay

Abaxis, a medical products company manufacturing point-of-care blood analysis systems, has received FDA 510K marketing clearance for the new C-Reactive Protein (CRP) assay. It is used by healthcare professionals in conjunction with the Piccolo Xpress analyzer.

The company claims that as a result of this approval, US healthcare professionals can 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 used as an indicator of inflammation or infection and will initially be made available to the US market on an acute care panel called MetLyte Plus CRP.

The 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.

Clint Severson, chairman and chief executive officer of Abaxis, said: “With the addition of the CRP assay, Abaxis continues to add valuable specialty tests to its already broad general chemistry menu offering.

“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 US, in Europe and Asia Pacific for over six months. In these regions, CRP is widely used as a standard test in general health screenings and as part of routine clinical practice.