David, Here is the latest news: -------------------------------------------------------------------------------------------- ABAXIS launches new hepatic function reagent disc; for use in Piccolo, VetScan point-of-care analyzers
SUNNYVALE, CALIF. (Nov. 6) BUSINESS WIRE -Nov. 6, 1996--ABAXIS Inc. (NASDAQ/NM:ABAX), a medical products company, Wednesday announced it has launched a new reagent disc product, the Liver Panel Plus 9, exclusively designed to measure hepatic function with its Piccolo Point-of-Care Blood Analyzer.
Recent receipt of 510(k) market clearance from the Food and Drug Administration (FDA) of the liver enzyme test, gamma glutamyl transferase (GGT), has enabled the company to market this product. A similar product, the Liver Profile, already has been launched to the veterinary market for use in ABAXIS' VetScan system.
"The Liver Panel Plus 9 fills a real medical need and will supply clinicians with essential information to make evaluations on liver function," said Clint H. Severson, ABAXIS' president and chief executive officer. "This product is one of several disease- or organ-specific diagnostic panels that we plan to develop and market to provide health-care professionals with rapid and easy diagnosis of specific organ or disease states."
In September, ABAXIS received 510(k) market clearance for its GGT test from the FDA, bringing to 16 the total number of tests cleared, and 17 the total tests marketed by the company. ABAXIS configures these tests into different combinations designed to serve unique diagnostic information needs of health-care professionals.
For its Piccolo System, the company offers seven reagent disc products including the General Health Panel 11, General Health Panel 8, Liver Panel Plus 9, General Chemistry 6, General Chemistry 7, General Chemistry 9 and General Chemistry 12. For the VetScan System, five reagent disc products are offered: Diagnostic Profile, Diagnostic Profile Plus, Prep Profile, Thyroxine (T4) and Liver Panel.
Additionally, the company markets two more reagent discs specifically designed to meet the needs of its Japanese customers.
This news release contains words that identify forward-looking statements which are made in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
The future events described in such statements involve risks and uncertainties, among them, but not limited to, risks and uncertainties related to the market acceptance of its products and the continuing development of the company's products, including required FDA clearance and other governmental approvals, risks associated with manufacturing and distributing its products on a commercial scale, including complying with federal and state food and drug regulations, general market conditions, competition and other risks detailed from time to time in ABAXIS' SEC reports.
Founded in 1989, 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 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 routine tests on whole blood using either venous or fingerstick samples. The system provides test results in less than 14 minutes with the precision and accuracy equivalent to a clinical laboratory.
--30--RPL/la*
CONTACT: ABAXIS Inc., Sunnyvale Ting Lu, 408/745-6851 or Pondel Parsons & Wilkinson, Los Angeles Rob Whetstone, 310/207-9300 Internet: investor@pondel.com
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* * * * * * * * * * Dan Byrne
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