Abbott wins CE mark for diabetes Dx

Abbott won a CE mark for a new diabetes test for its Architect analyzers.--Courtesy of Abbott

Abbott Laboratories ($ABT) has locked down European approval for a new diabetes diagnostic, getting the green light to market a test that can help diagnose and monitor diabetics as well as flag patients at risk for developing the disease.

The Hemoglobin A1c--or HbA1c--test works with Abbott's Architect diagnostics platform, using a patient's blood draw to reveal the average blood glucose levels over the past three months.

With that information, physicians can more easily chart the progression of diabetes and manage treatment for patients with or at risk for the ailment, Abbott said.

"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," Abbott Diagnostics Vice President Brian Blaser said in a statement. "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."

The CE mark allows Abbott to start selling the test in countries across Europe, Asia, Latin America, and Africa, as well as Canada, the company said. Abbott has also filed for FDA clearance to get the diagnostic available in the U.S.

Diagnostics revenue is of the utmost importance to the post-pharma Abbott. Now that the company has jettisoned its proprietary drug business into AbbVie ($ABBV), Abbott is counting on continued growth in diagnostics to prop up its slumping medical device sales. Last quarter, Abbott Diagnostics grew 4.4% to $1.1 billion, fueled by a 3.6% jump in the core lab segment and a 17.3% leap in Abbott's small but fast-growing point-of-care business.

- read the announcement

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