- The new fully-automated assay measures glycated hemoglobin (HbA1c), the recommended test to monitor diabetic patients in the laboratory

ABBOTT PARK, Illinois, July 10, 2012 /PRNewswire/ -- More than 346 million people worldwide are living with diabetes, and the World Diabetes Foundation estimates that number will increase by nearly 27 percent by 2030. In order to help physicians appropriately monitor treatment efficacy for these patients, Abbott (NYSE: ABT) announced today CE Marking (Conformite Europeenne) for the Abbott ARCHITECT HbA1c (IA) Assay. 

Glycated hemoglobin, also known as HbA1c, is a form of hemoglobin used primarily to monitor long-term diabetes control. This helps physicians understand how well the patient's diabetes is being managed from a treatment or dosing perspective. The HbA1c test differs from a patient-administered blood glucose test, which takes a snapshot of a patient's blood sugar level at a moment in time. The HbA1c test must be performed on a laboratory instrument. 

Laboratories are seeing an increase of HbA1c testing volumes worldwide due to the rise in patients with diabetes. The Abbott ARCHITECT HbA1c assay is a fully automated chemiluminescent immunoassay to help laboratories manage the increased demand and offer rapid results to physicians. With a simple blood test, the Abbott ARCHITECT HbA1c (IA) Assay provides a result to the physician in just 36 minutes. It also demonstrates a good correlation to the gold standard (high performance liquid chromatography), which provides confidence in the accuracy and reproducibility of patient results.

"Abbott's ARCHITECT HbA1c (IA) Assay allows for consistent and accurate testing of HbA1c," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "We are pleased to offer an important tool to address the need for a fully automated glycated hemoglobin assay which can meet the demands of increased testing volumes.

With this test, health care providers can now confidently measure their patients' management of diabetes and use this information to potentially improve treatment decisions."

The new assay is performed on the ARCHITECT immunoassay systems and is available in several European countries, Asia Pacific, Latin America, Japan, Africa, Middle East and India, pending country registration.

Intended Use
The ARCHITECT HbA1c (IA) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used in the clinical management of diabetes to assess long-term diabetic control.

About Abbott ARCHITECT
Abbott has developed and launched a series of ARCHITECT analyzers that are delivering unprecedented flexibility, automation, and convenience to today's clinical laboratory. The first truly integrated portfolio of immunoassay and clinical chemistry instruments, ARCHITECT offers more than 170 assays and has features that minimize training and reduce inventory costs and sample contamination potential, which results in improved performance and outcomes for laboratories, physicians, and patients. 

About Abbott Diagnostics
Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices, and clinics. With more than 22,000 customers in more than 100 countries, Abbott's diagnostic products offer customers automation, convenience, bedside testing, cost-effectiveness, and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company's commitment to improving patient care and lowering costs.

About Abbott Diabetes
Abbott markets a number of products to aid in the diagnosis and treatment of diabetes. Its FreeStyle line of blood glucose monitors – including Precision and Optium – are easy-to-use, require small blood samples and provide fast and accurate test results. Abbott's i-STAT and ARCHITECT systems feature various tests to diagnose diabetes and monitor glucose levels in the hospital and laboratory settings. Glucerna shakes and bars are formulated for people with diabetes to help manage blood glucose levels as part of a diabetes management plan.

About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.

Abbott's information and news releases are available on the company's Web site at www.abbott.com.

SOURCE Abbott