Abbott Announces FDA Clearance for a New Test to Help Physicians Quickly and Accurately Diagnose Diabetes

Abbott announced today that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test - which can aid physicians in diagnosing and monitoring diabetes and identifying people at risk for the disease - has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). More than 25 million Americans are living with diabetes and several million remain undiagnosed.1 People with diabetes who can understand and manage their condition can prevent or delay health problems, which may lead to longer and healthier lives.

"At times, diabetes can be difficult to diagnose because the symptoms can be subtle or go unnoticed," said Beth McQuiston, MD, registered dietitian, and medical director, Diagnostics, Abbott. "The new HbA1c test provides physicians the ability to quickly assess a person's average blood glucose concentration over several months, and if needed, provide them with a treatment pathway to help optimize their health."
If current trends continue, as many as one in three U.S. adults could have diabetes by 2050.1 Due to this potential rise, laboratories are expected to see an increase in physician requests for HbA1c tests. The fully-automated Abbott ARCHITECT HbA1c test provides fast, accurate results, helping laboratories manage this anticipated increase in demand for testing.

"The progression of diabetes may be prevented or delayed with effective care," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "Abbott's ARCHITECT clinical chemistry HbA1c test will empower physicians to take timely, appropriate actions in identifying and helping people manage this disease."

The ARCHITECT clinical chemistry HbA1c test is now available in several countries throughout Europe, Asia, Latin America, Canada and Africa, pending country registration. The test will be available in the U.S. in the coming weeks.

Abbott's HbA1c Test
The ARCHITECT HbA1c assay is used in clinical laboratories for the quantitative in vitro measurement of the percent hemoglobin A1c (% HbA1c) or the hemoglobin A1c concentration (mmol/mol) in human whole blood and hemolysate on the ARCHITECT c8000 System. Hemoglobin A1c measurements are used as an aid in the diagnosis of diabetes mellitus, to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. Hemoglobin A1c should not be used for the diagnosis of diabetes in patients with abnormal red cell turnover, such as pregnancy, recent blood loss or transfusion, or some types of anemia.2

Abbott's Commitment to Diabetes Management
Abbott markets a number of products to aid in the diagnosis, monitoring and management of diabetes. Abbott's ARCHITECT and i-STAT® System feature various tests to either diagnose diabetes or monitor blood glucose levels. Its FreeStyle line of blood glucose monitors are easy-to-use, require small blood samples and provide fast and accurate test results.2 The company also offers Glucerna®, specialized nutrition products that are designed to help people with diabetes manage blood glucose levels as part of an overall management plan.

1 Number of Americans with diabetes rises to nearly 26 million: More than a third of adults estimated to have prediabetes. Centers for Disease Control and Prevention (CDC) Jan. 26, 2011 press release. Website: www.cdc.gov/media/releases/2011/p0126_diabetes.html. Accessed March 26, 2014.
2 FreeStyle brand of products is intended for testing outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The products should not be used for the diagnosis of or screening for diabetes or for neonatal use.