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Abbott and Seradyn Announce U.S. Clearance for Hemoglobin A(1C) (HbA(1C)) Test
For Diabetes
- By Monitoring Glucose Levels, Patients Can Help Reduce Their Risk Of
Developing Long-Term Diabetic Complications (Blindness, Amputation and Kidney
Damage) -
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.
About Seradyn
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.
(NYSE:AOT) 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/ .
DATASOURCE: Abbott Laboratories
CONTACT: Media, Amy Woodworth, +1-847-935-4755, or Financial Community,
Christy Wistar, +1-847-938-4475, both of AbbottLaboratories
Web site: http://www.abbott.com/
http://www.seradyn.com/
Company News On-Call: http://www.prnewswire.com/comp/110328.html