Abaxis Receives CLIA Waiver For Capillary Sampling For Cholesterol, HDL And Triglycerides
U.S. Healthcare Professionals Now Can Perform Lab-Accurate Lipid and Liver Diagnostics with a simple fingerstick using the Piccolo® Blood Chemistry Analyzer.
UNION CITY, Calif., March 28, 2014 /PRNewswire/ — Abaxis, Inc. (NasdaqGS: ABAX), a medical products company manufacturing point-of-care blood analysis systems, today announced the Food and Drug Administration granted CLIA waived status for capillary draw for CHOL, HDL and TRIG. Combined with existing CLIA waived tests for liver diagnostics using capillary samples, Abaxis now has two complete Lipid Panels which can be used by healthcare professionals to diagnose, treat and monitor hyperlipidemia patients using a sample obtained from either venous blood or a capillary draw.
Obtaining CLIA waived status for capillary sampling is an important step in bringing comprehensive care closer to the patients in the U.S. With the new cholesterol guidelines released by the American Heart Association last November, which reduced statin medication thresholds, healthcare professionals, health screeners, pharmacy/retail health chains and occupational health organizations can have lab-accurate lipid, liver, glucose and triglyceride diagnostic results in 12 minutes without the need for a certified phlebotomist. Now the estimated 13 million more Americans who will be eligible for cholesterol-lowering medications can be assured of quick and accurate lab results to help diagnose and monitor their treatment progress.
“The FDA’s granting of our CLIA waiver applications for capillary-obtained lipids is an important step to improving the healthcare system,” said Clint Severson, chairman and chief executive officer of Abaxis, Inc. “We all know that high cholesterol can lead to heart disease and other serious afflictions. The key to lower healthcare costs is catching these problems early, before the real and expensive damage is done. Now healthcare professionals can do a simple fingerstick to diagnose, treat and monitor hyperlipidemia patients with greater ease than ever.”
“Abaxis is also now the only company that provides a capillary or venous CLIA waived Lipid and Liver panel to monitor statin medications at the point-of-care,” Severson added. “Cholestech took their liver function tests off the market last year, leaving the Piccolo as the sole trusted provider of on-site statin-monitoring blood chemistry diagnostics.”
With the Piccolo delivering lab-accurate blood chemistry results on-site in minutes, physicians can make confident treatment decisions while the patient is in their office, thereby increasing the speed and quality of care while reducing the unreimbursed time spent preparing labs and relaying patient results. The capability to diagnose and treat in one visit can have a dramatic impact on practice throughput. Clinics can see more patients each day by eliminating unnecessary call-backs and follow up visits due to standard 24-hour lab turnaround. And, by having immediate results while they’re in front of the physician, patients can experience the real impact of their compliance or non-compliance to treatment regimens, which can improve outcomes and reduce hospitalizations.
Abaxis develops, manufactures and markets portable blood analysis systems for use in any veterinary or human patient-care setting to provide clinicians with rapid blood constituent measurements. The system consists of a compact, 5.1 kilogram (11.2 pounds), portable analyzer and a series of single-use plastic discs, called reagent discs that contain all the chemicals required to perform a panel of up to 14 tests on veterinary patients and 31 tests on human patients. The system can be operated with minimal training and performs multiple routine tests on whole blood, serum or plasma samples. The system provides test results in less than 12 minutes with the precision and accuracy equivalent to a clinical laboratory analyzer.
The Piccolo Xpress and reagents are sold exclusively through Abbott Point of Care in the United States. For more information please visit http://www.piccoloxpress.com/distributors/
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,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this press release or in our conference call may be affected by risks and uncertainties, including, but not limited to, those related to the market acceptance of the company’s products and the continuing development of its products, required United States Food and Drug Administration clearance and other government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with entering the human diagnostic market on a larger scale, risks associated with liquidity concerns related to our auction rate securities, risks related to the protection of the company’s intellectual property or claims of infringement of intellectual property asserted by third parties, predictions related to condition of the United States economy, risks involved in carrying of inventory 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 statements were made. Abaxis does not undertake and specifically disclaims any obligation to update any forward-looking statements.
Contact: Clint Severson Lytham Partners, LLC Chief Executive Joe Dorame, Robert Officer Blum and Joe Diaz Abaxis, Inc. 602-889-9700 510-675-6500
SOURCE Abaxis, Inc.