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FDA Approves Roche's New HCV Test

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Roche (RHHBY) recently announced that it has received approval from the US Food and Drug Administration (:FDA) for a next-generation viral load test.

The test uses a novel dual-probe approach and thereby provides an extra layer of protection in detecting and quantifying the hepatitis C virus (:HCV). The test can precisely determine the level of hepatitis C virus ribonucleic acid (:RNA), which in turn determines a patient’s response to antiviral therapy. Hence, the test enables better management of patients with chronic HCV infection.

Roche plans to ship the new HCV viral load test kit in the US shortly. In 2012, Roche launched HCV II, an immunoassay to detect hepatitis C infections. The new HCV viral test is part of Roche’s diagnostic tests to diagnose hepatitis C infection.

We note that Roche’s Diagnostics Division had launched several new instruments and devices in 2012 to enable advances in lab automation, near patient testing and diabetes management along with expanding oncology, virology and metabolic test menus.  

We note that Roche has received encouraging news regarding its oncology drugs over the last month. In Feb 2013, the FDA approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of patients suffering from HER2-positive metastatic breast cancer (mBC).

A few days back the European Medicines Agency (:EMA) approved Perjeta (pertuzumab) as a combination therapy for the treatment of adults with previously untreated HER2-positive mBC. The FDA had approved Perjeta plus Herceptin and docetaxel chemotherapy for treating HER2-positive mBC in patients in Jun 2012.

We are positive on the recent developments at Roche. Roche currently carries a Zacks Rank #3 (Hold). Pharma stocks, which currently look well placed, include Novo Nordisk (NVO), Lilly Eli & Co (LLY) and Shire plc (SHPG). All three stocks carry a Zacks Rank #2 (Buy).

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