Roche Accu-Chek Combo Gets FDA Nod

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The US Food and Drug Administration (:FDA) recently cleared Roche Holdings Ltd.’s (RHHBY) Accu-Chek Combo system for insulin pump therapy. The system helps the patient to test blood glucose levels and also supports in defining the right amount of insulin.

Roche expects the system to hit the US market in the second half of 2012. The Accu-Chek Combo system is already available in several European and Asia-Pacific countries like France, Germany, UK and Australia. The Accu-Chek brand (more than 35 years old) has helped Roche’s Diabetes Care to become a global leader in diabetes management systems and services.

We remind investors that in January this year, the FDA cleared Roche’s Accu-Chek Nano SmartView system. This system, which is smaller than a standard credit card, is already launched in the US. Moreover, Roche’s Accu-Chek Aviva Nano and Accu-Chek Performa Nano systems, which are part of the same product line, are already available in Europe, Latin America and Asia-Pacific.

As per the National Diabetes Fact Sheet published by the Centers for Disease Control and Prevention, more that 25 million US citizens live with diabetes and around 75 million live with pre- diabetes.

Earlier this month, Roche received premarket approval for a new test from the FDA. The test aims to assess a patient's viral load of cytomegalovirus (:CMV). This is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. Shipping of the new CMV test kit in the US is expected in August 2012.

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Roche, headquartered in Basel, Switzerland, carries a Zacks #4 Rank (Sell rating) in the short run.

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