Healthcare Industry News: albumin
News Release - October 18, 2006
Abaxis Announces CLIA Waived Status
The Liver Panel Plus Is the Third Test Panel to Receive CLIA Waived StatusUNION CITY, Calif., Oct. 18 (HSMN NewsFeed) -- 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 six additional analytes -- albumin (ALB), Alkaline Phosphatase (ALP), Amylase (AMY), Gamma Glutamyltransferase (GGT), Total Bilirubin (Tbili), and Total Protein (TP) -- when used in conjunction with the Piccolo point-of-care analyzer for the medical market. The Company now has a total of twelve analytes that have received the CLIA waived status.
"In obtaining CLIA waived status for these analytes, we can now offer the Liver Panel Plus along with the Lipids Panel and Lipids Plus Panel as waived tests to the medical market," commented Clint Severson, chairman, president and CEO of Abaxis, Inc. "This is another step forward in our goal of achieving waived status on all of our medical test panels. Our next submission to the FDA for waived status will consist of analytes from our General Chemistry Panels 13 and 6."
Dr. Dennis Bleile, director of assay performance and compliance for Abaxis, Inc. said, "Many lipid lowering medications and chemotherapeutic agents used in the out-patient setting are metabolized by the liver. Since these drugs are often toxic, liver function must be routinely monitored and drug dosage adjusted accordingly. The ability for physicians to rapidly assess liver function in an office or outpatient setting easily and reliably is vital to providing the best treatment possible."
"As we continue to expand our ease of use features with the Piccolo, we believe more physicians will realize the treatment benefits and office efficiencies of on-site chemistry," stated Christopher Bernard, VP of sales and marketing.
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.
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.
Source: Abaxis
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