Roche Holdings Ltd.
) 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
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
Roche, headquartered in Basel, Switzerland, carries a Zacks #4
Rank (Sell rating) in the short run.
(RHHBY): ETF Research Reports
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