Abbott Laboratories announced that its development partner, Seradyn, has received clearance from the US Food and Drug Administration (FDA) for a hemoglobin A1c (HbA1c) assay for use on Abbott's Architect c8000, Architect ci8200 and Aeroset immunochemistry systems. Tracking hemoglobin A1c levels through lab testing provides doctors with the data they need to monitor their patients' diabetes and prescribe the appropriate treatment. Abbott's Multigent HbA1c 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 HbA1c test.

"Our Multigent HbA1c test uses standardization, defined by the National Glycohemoglobin Standardization Program, or NGSP, and will provide consistent and precise reporting of results, " said Jim Koziarz, 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 A1c. 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 Rolla, 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.