FDA Nod for Roche Test

Roche Holdings Ltd. ( RHHBY ) recently announced that it received premarket approval (PMA) from the US Food and Drug Administration (FDA) for a new test. The fully automated COBAS AmpliPrep / COBAS TaqMan CMV 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. The information from the test is used by physicians to manage patients who have been diagnosed with CMV disease. Shipping for the new CMV test kit in the US is expected in August 2012.

As per company sources, around 50–80% of the total people in the US are infected with the most common viral infection, CMV.

Notably, Roche’s product portfolio includes Valcyte for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valcyte sales amounted to CHF 153 million in the first quarter of 2012.

Recently, the company was in the news for cutting down its research and development activities. Roche closed its site in Nutley, New Jersey.

On a brighter note, the company unveiled positive results from a phase III study on Perjeta (pertuzumab). Perjeta received FDA approval for the combination of Perjeta, Roche’s existing breast cancer drug Herceptin, and docetaxel chemotherapy. Roche is also seeking European approval of the combination therapy for treatment-naïve HER2- positive metastatic breast cancer patients.

Roche also announced that it entered into an agreement with Seaside Therapeutics for the development of treatments for neurodevelopmental disorders – fragile X syndrome and autism spectrum disorders.

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