Abbott Announces CE Mark for Test to Aid Doctors with Diagnosing and Monitoring Diabetes

     Abbott Announces CE Mark for Test to Aid Doctors with Diagnosing and
                             Monitoring Diabetes

  PR Newswire

  ABBOTT PARK, Illinois, May 9, 2013

ABBOTT PARK, Illinois, May 9, 2013 /PRNewswire/ -- Abbott (NYSE: ABT) today
announced CE Marking (Conformité Européenne) for the ARCHITECT clinical
chemistry Hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing
and monitoring diabetes as well as identifying patients at risk for developing
diabetes.

As of 2012, more than 371 million people worldwide were living with diabetes
and half of the people with diabetes remained undiagnosed. If left undiagnosed
or not properly managed, diabetes can cause serious health complications.[1]

The HbA1c test is a blood test that reflects a person's average blood glucose
levels over the past three months. In 2009, an international expert committee
recommended that physicians may use an HbA1c test for the diagnosis of type 2
diabetes and identification of patients at risk for developing diabetes if the
assay meets specific performance criteria, such as certification and
standardization processes outlined by the National Glycohemoglobin
Standardization Program (NGSP) and the International Federation of Clinical
Chemistry (IFCC).

"The new ARCHITECT clinical chemistry Hemoglobin A1c test provides physicians
with important information that may help patients take critical steps to
manage the progression of this very serious disease," said Christian Fischer,
senior medical director, Diagnostics Products, Abbott.

Diabetes can be managed by using diabetes medicines, making important
lifestyle changes related to diet and exercise, and monitoring blood glucose
and HbA1c levels.[2] For people whose HbA1c test results are normal, doctors
may recommend that testing be repeated at least every three years or more
frequently depending on a person's initial results and risk status.[2]

"When diabetes is not managed properly, it can lead to damage of important
systems in the body, including the heart, kidneys, and eyes, and even cause
life-threatening complications," said Brian Blaser, executive vice president,
Diagnostics Products, Abbott. "With the CE Mark of Abbott's ARCHITECT clinical
chemistry HbA1c test, we are pleased to offer this valuable tool to help
doctors diagnose diabetes and identify patients at-risk for developing
diabetes. Doctors can use this information to improve patient care."

The ARCHITECT clinical chemistry HbA1c test is available in several countries
throughout Europe, Asia, Latin America, Canada and Africa, pending country
registration. Abbott recently filed for 510(k) clearance with the U.S. Food
and Drug Administration.

Intended Use

The ARCHITECT HbA1c assay is used in clinical laboratories for the
quantitative in vitro measurement of the percent hemoglobin A1c or HbA1c
fraction in human whole blood and hemolysate on the ARCHITECT c 8000 and c
4000 Systems. 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]

About Diabetes and Patients at Risk for Diabetes

Diabetes occurs when the body does not produce enough insulin or when the body
cannot effectively use the insulin it produces. Insulin is a hormone that
helps the body use glucose (sugar) for energy. People with blood glucose
levels that are higher than normal, but not high enough for a diagnosis of
diabetes, are at increased risk for developing type 2 diabetes.[3]

Worldwide more than four million people died due to diabetes in 2012, which is
roughly one person every eight seconds. Of the more than four million people
in the world who died due to diabetes in 2012, half were under the age of 60.
In 2012, $471 billionUnited States dollars were spent globally as a result of
diabetes.[1]

About Abbott's Commitment to Diabetes

Abbott markets a number of products to aid in the diagnosis, monitoring and
treatment of diabetes. Abbott's ARCHITECT systems and i-STAT feature various
tests to diagnose diabetes and monitor glucose levels in the hospital and
laboratory settings. 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. 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 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

Abbott is a global healthcare company devoted to improving life through the
development of products and technologies that span the breadth of healthcare.
With a portfolio of leading, science-based offerings in diagnostics, medical
devices, nutritionals and branded generic pharmaceuticals, Abbott serves
people in more than 150 countries and employs approximately 70,000 people.

Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.

[1] International Diabetes Federation. IDF Diabetes Atlas, 5th edn. Brussels,
Belgium: International Diabetes Federation, 2011.
http://www.idf.org/diabetesatlas . Accessed March 20, 2013.

[2] The A1C Test and Diabetes. National Diabetes Information Clearinghouse.
U.S. Department of Health and Human Services. June 2012.

[3] Diagnosis of Diabetes and Prediabetes; National Diabetes Information
Clearinghouse. U.S. Department of Health and Human Services. July 2012.

Website: http://www.abbott.com
Contact: Media, Darcy Ross, (847) 937-3655; or Jessica Masuga, (847) 935-0650,
or Financial, Tina Ventura, (847) 935-9390
 
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