Basel, 29 September 2011
Roche receives clearance from the U.S. Food and Drug Administration for new generation of Accu-Chek Aviva Plus Test Strips for people with diabetes
New generation of test strips offers advanced chemistry and safety for self-monitoring of blood glucose
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Accu-Chek Aviva Plus test system. The new maltose-independent test strip is designed to prevent the interference of maltose on blood sugar readings which can occur in rare cases when drugs containing or metabolizing to maltose are parenterally administered. The Accu-Chek Aviva Plus test strip is cleared for patient self-monitoring of blood glucose and can be used with the proven Accu-Chek Aviva system*.
“We are very pleased to announce that our new product for self-monitoring of blood glucose will also be available for people with diabetes in the US,” said Daniel O’ Day, Chief Operating Officer of Roche Diagnostics. “With its advanced technology and chemistry it is designed to support patients to manage their condition more effectively. This clearance is a significant milestone for our organization – one that will position us well for the clearance of other products in our pipeline.”
According to the 2011 National Diabetes Fact Sheet published by the Centers for Diseases Control and Prevention, more than 25 million people in the US live with diabetes. However, seven million are currently undiagnosed and 1.9 million new cases of diabetes were diagnosed in people aged 20 years and older in 2010. It is also estimated that 79 million people live with pre-diabetes in the US.
* for single patient use only