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 (FDA) has granted waived status under CLIA regulations for four additional analytes, Calcium (CA), Creatinine (CRE), Urea Nitrogen (BUN), and Uric Acid (UA), when used in conjunction with the Piccolo and Piccolo Xpress point-of-care analyzers for the medical market.
"In obtaining CLIA waivers on four additional analytes, we have achieved waived status on sixteen analytes, which represents 70% of the analytes we sell into the medical market. We can now provide the General Chemistry 13 panel, which is a comprehensive screening panel, the General Chemistry 6 panel, the Liver Panel Plus, the Lipids Panel and the Lipids Plus Panel, as CLIA waived test panels to the medical market.
"The FDA, through the waived status process, continues to validate our belief that any medical practice using our Piccolo, or our recently released Piccolo Xpress analyzers, can achieve the same results as the highly regulated, complex and expensive systems most commonly in use today," commented Clint Severson, chairman, president and CEO of Abaxis, Inc. "We are very pleased with the consistent progress we are making in completing a full complement of diagnostic tests that can dramatically increase the efficiency of the medical practices that utilize our technologies."
Dr. Dennis Bleile, director of assay performance and compliance for Abaxis, Inc. said, "Having a CLIA waived general health panel that permits simultaneous determination of 13 results from a single small sample is unique and a big step forward in demonstrating the feasibility of moving routine chemistry testing from the central laboratory to every physician's office."
About Abaxis, Inc.
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.
"In obtaining CLIA waivers on four additional analytes, we have achieved waived status on sixteen analytes, which represents 70% of the analytes we sell into the medical market. We can now provide the General Chemistry 13 panel, which is a comprehensive screening panel, the General Chemistry 6 panel, the Liver Panel Plus, the Lipids Panel and the Lipids Plus Panel, as CLIA waived test panels to the medical market.
"The FDA, through the waived status process, continues to validate our belief that any medical practice using our Piccolo, or our recently released Piccolo Xpress analyzers, can achieve the same results as the highly regulated, complex and expensive systems most commonly in use today," commented Clint Severson, chairman, president and CEO of Abaxis, Inc. "We are very pleased with the consistent progress we are making in completing a full complement of diagnostic tests that can dramatically increase the efficiency of the medical practices that utilize our technologies."
Dr. Dennis Bleile, director of assay performance and compliance for Abaxis, Inc. said, "Having a CLIA waived general health panel that permits simultaneous determination of 13 results from a single small sample is unique and a big step forward in demonstrating the feasibility of moving routine chemistry testing from the central laboratory to every physician's office."
About Abaxis, Inc.
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.
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