This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

Abbott Announces CE Mark For Test To Aid Doctors With Diagnosing And Monitoring Diabetes

ABBOTT PARK, Ill., 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 c8000 and c4000 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 billion United 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.

1 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Try it NOW
Only $9.95
Try it NOW
14-Days Free
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 17,982.22 +269.56 1.52%
S&P 500 2,087.89 +26.87 1.30%
NASDAQ 4,946.5920 +55.3730 1.13%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs