ABBOTT PARK, Ill., March 5 /PRNewswire-FirstCall/ -- Abbott Laboratories announced today that its development partner, Seradyn, has received clearance from the U.S. Food and Drug Administration (FDA) for a hemoglobin A(1C) (HbA(1C)) assay for use on Abbott's ARCHITECT(R) c8000(TM), ARCHITECT(R) ci8200 and Aeroset(R) immunochemistry systems. Tracking hemoglobin A(1C) levels through lab testing provides doctors with the data they need to monitor their patients' diabetes and prescribe the appropriate treatment. Abbott's Multigent(TM) HbA(1C) assay provides precise and accurate test results and gives labs an efficient and cost-effective test that can be integrated into their current systems. Abbott will exclusively distribute the Multigent(TM) HbA(1C) test.
"Our Multigent(TM) HbA(1C) test uses standardization, defined by the National Glycohemoglobin Standardization Program, or NGSP, and will provide consistent and precise reporting of results," said Jim Koziarz, Ph.D., vice president, research and development, diagnostics, Abbott Laboratories.
"The treatment of diabetes is based on the control of blood sugar levels. For the day-to-day control of blood sugars, home blood glucose monitoring gives patients the information they need daily. However, it is also important to assess the overall control of blood sugars by monitoring glycohemoglobin A(1C). This is a routine lab test that all doctors are running on their patients with diabetes every three to four months and changes in treatment, diet and exercise programs are based on these results," said Arturo R. Rolla, M.D., associate clinical professor of medicine, Harvard Medical School.
Diabetes mellitus is a chronic disease affecting an estimated 177 million people worldwide and this number continues to grow. Early diagnosis and monitoring of the disease is key to managing and preventing serious complications and premature death.
Since 1984, Seradyn has been an industry leader in the development of products and technologies for research and clinical markets worldwide. Seradyn is a leading diagnostic reagent developer in the areas of therapeutic drug monitoring (TDM) and human serology. Seradyn is a subsidiary of Apogent Technologies Inc. a leading manufacturer of clinical diagnostic and life science research products. For more information, visit Seradyn's Web site at http://www.seradyn.com/ .
About Abbott Laboratories
Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals and medical products, including devices and diagnostics. The company employs more than 70,000 people and markets its products in more than 130 countries. Abbott 's news releases and other information are available on the company's Web site at http://www.abbott.com/ .
CONTACT: Media, Amy Woodworth, +1-847-935-4755, or Financial Community,Christy Wistar, +1-847-938-4475, both of Abbott Laboratories