Media/Investor Kit - ABS2000 FDA Press Release
FDA Clears Immucor to Market ABS2000
First Fully Automated Blood Bank System Increases Safety and Productivity
(Norcross, Georgia - July 6, 1998) - Immucor, Inc. (NASDAQ: BLUD), Announced today that the U.S. Food and Drug Administration (FDA) has given clearance for the Georgia-based company to market its ABS2000, the first fully automated blood bank system, in the United States.
Benefits of totally automating routine blood lab tests are increased efficacy, improved productivity resulting in economic advantages, and greater confidence in test results. The ABS2000 reduces standard serology tests from 23 manual tasks to three steps; 1) load samples; 2) choose the assay; and 3) walk-away.
"ABS2000 represents an excellent opportunity to dramatically change routine hospital transfusion laboratory testing as we know it, and solidifies our position as a company with solutions for this industry," said Edward L. Gallup, president and CEO of Immucor.
The ABS2000 currently provides more than 20,000 patient test results monthly in Europe and Canada. Clinical trials were performed at sites across the U.S. including large university hospitals, reference laboratories, donor centers, and community hospitals.
"We look forward to integrating the ABS2000's walk away features into our workflow, saving laboratory technologist time for more important tasks," said Dr. S. Gerald Sandler, professor of Medicine and Pathology and director of Blood Bank and Donor Service, at Georgetown University Medical Center in Washington, D.C., which serves as a clinical trial site for the system.
With this fully automated system, Immucor closes the loop in the administration of blood, and continues toward its goal of making blood compatibility testing procedures faster, easier, and more efficient. The ABS2000 system improves quality assurance, solves staffing problems, and minimizes training concerns; reduces sample handling and exposure to infectious agents; improves data management; reduces risk from human error; eliminates subjectivity from interpreting results; increases accuracy; and brings additional safety for patients.
There are more than 2500 facilities in the United States that can benefit from the quality and productivity improvements provided by the ABS2000 system. With no competition in automation for blood banks, Immucor has a distinct competitive advantage in the hospital transfusion service market, and expects to have the first ABS2000 systems installed within the next 60 days.
Founded in 1982, Immucor, which was originally a producer of blood bank reagents for manual testing, has moved to a leading role as a supplier of integrated systems (instruments, software, disposables and reagents) to hospitals, laboratories, and blood donor centers that automate manual testing procedures. For product information, visit the website at immucor.com or call 1-800-829-2553, extension 3. |
