UNION CITY, Calif., May 31 /PRNewswire-FirstCall/ -- ABAXIS, Inc. , announced today that it is providing medical clinicians world wide with a new Piccolo(R) Lipid Panel Plus to diagnose patients for heart disease, metabolic syndrome and liver enzyme monitoring combined in one simple to use point-of-care test. Results are available to the physician for immediate diagnosis and treatment while the patient is on site.
The new Lipid Panel Plus with the addition of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and glucose can now provide the medical community with the first simultaneous screening and monitoring tool for the management of patients’ cardiac health and treatment outcomes. Commented Clint Severson, Chairman, President and Chief Executive Officer of ABAXIS, “We added glucose because diabetes is often a complicating factor for many of these patients. Now, as with all our panels, the physician has all the needed answers in just minutes.”
Lou Ramondetta, V.P. Sales and Marketing, adds that, “ABAXIS is dedicated to become the leader in the fast growing Point-of-Care clinical chemistry testing market by providing physicians and their patients with rapid, real time diagnostic results. This key product addition will enable the ABAXIS Piccolo Chemistry Analyzer to expand our position in the primary care market.
The Lipid Panel Plus meets the performance criteria set by the Center for Disease Control Cholesterol Reference Method Laboratory Network (CRMLN). Certification through this program is the ultimate demonstration of accuracy in total and HDL cholesterol testing. ABAXIS can assure our customers that they will be achieving -- in a point of care setting -- the highest standard of lipids measurement. “
“In concert with the clinical evaluations of our new product, we performed the required field-testing and submitted our CLIA waiver application for the remaining assays on the Lipid Panel Plus to the U.S. Food and Drug Administration,” states Kenneth Aron, Vice President of Research and Development. “Our total cholesterol (CHOL), high-density lipoprotein cholesterol (HDL) and triglycerides (TRIG) are already waived. To receive a FDA waiver is valuable for both the physician and patient. It establishes that our tests are so accurate and easy to perform that routine inspection and proficiency testing are not required.”
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, which 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. The system provides test results in less than 13 minutes with the precision and accuracy equivalent to a clinical laboratory.
Further information on CRMLN and lipid testing guidelines can be found on the CDC website at www.cdc.gov/labstandards/crmln.htm.
This press release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”). ABAXIS claims the protection of the safe-harbor for forward-looking statements contained in the Reform Act. These forward- looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” or “anticipates,” and do not reflect historical facts. 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 seeking approval of some of our products from the U.S. Food and Drug Administration, 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 stemming from further possible terrorist attacks after September 11, problems caused by electricity-related issues in California (including, but not limited to, utility costs and “brownouts” or “blackouts” which may cause production delays), risks involved in carrying of inventory, risks from unexpected problems or delays in the Company’s new manufacturing facility, risks associated with the ability to attract and retain competent sales personnel, general market conditions, competition 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.
ABAXIS, Inc.
CONTACT: Clint Severson, Chief Executive Officer of ABAXIS, Inc.,+1-510-675-6500; or Joe Dorame, Joe Diaz or Robert Blum of The RCG Group,+1-480-675-0400, for ABAXIS, Inc.
Web site: http://www.abaxis.com/