New Roche Test Available in the US

Roche Holdings Ltd. ( RHHBY ) recently announced that its new viral load test is now available in the US. The fully automated COBAS AmpliPrep / COBAS TaqMan CMV test aims to assess a patient's viral load of cytomegalovirus (CMV).

In July 2012, Roche had received premarket approval (PMA) from the US Food and Drug Administration (FDA) for this test. 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.

As per company sources, around 50–80% of the total population in the US are infected with CMV, the most common viral infection among solid organ transplant recipients.

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 307 million in the first half of 2012.

Recently, Roche provided an update on its research and development (R&D) programs and its strategy on innovation for unmet medical needs. The company expects results from 19 late-stage clinical trials in the next 18 months.

Of these, 12 studies are investigating new molecular entities (NMEs). Moreover, Roche expects three additional NMEs to reach the Lifecycle Investment Point (LIP) and move to late-stage development by year end. Roche allotted half of its R&D budget to its oncology segment.

Roche moreover implemented rigorous portfolio prioritisation, new development designs, and cost-saving initiatives to keep its R&D budget stable despite its significant pipeline progress.

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