Abbott Laboratories ($ABT) has snagged a CE mark for its Architect HbA1c assay, which tests glycated hemoglobin to determine how well patients are responding to diabetes therapy.
The test is a fully automated chemiluminescent immunoassay, and it provides results in 36 minutes, according to Abbott. Testing glycated hemoglobin is more precise and useful to physicians than blood glucose monitoring, Abbott says, because instead of taking a snapshot of blood sugar levels, the company's assay measures long-term results. The test uses Abbott's Architect platform, an immunoassay tech with more than 170 applications.
"With this test, health care providers can now confidently measure their patients' management of diabetes and use this information to potentially improve treatment decisions," said Brian Blaser, Abbott's diagnostics executive vice president, in a statement.
The approval allows Abbott to market the test in countries throughout Europe, Asia, Latin America and the Middle East. The company didn't disclose a timeline for FDA approval, but the CE mark certainly won't hurt Abbott's chances when it decides to file.
Abbott's diagnostics arm has been active over the past year, teaming with Merck ($MRK) in March to develop a cancer assay. And in 2011, the company worked with GlaxoSmithKline ($GSK) and Pfizer ($PFE) on two separate cancer companion diagnostics.
- read Abbott's release