Roche ($RHHBY) gained an expanded CE mark for a human papillomavirus test, a crucial win in the company's bid to expand its diagnostics arm and also grow its women's cervical cancer prevention business.
The new regulatory designation means Roche's cobas 4800 HPV test no longer has to be used along with Pap cytology in countries that rely on a CE mark. It's now a primary screening option, and crucial in the bid to confront HPV, which, as Roche notes, is the main cause of cervical cancer.
Roche already has U.S. approval for the test, which it bills as the only FDA-approved test that both pools results on known "high risk" genotypes as well as individual results on the highest risk-genotypes (HPV 16 and HPV 18).
The Swiss pharma giant took a big step in July 2011 to boost its cervical cancer diagnostics arm with its $184 million purchase of Germany's Mtm Laboratories, which developed in vitro diagnostics focused on the early detection and diagnosis of cervical cancer. Overall, however, Roche has also been betting big on diagnostics overall. CEO Severin Schwan told investors in early September that more than 60% of Roche's pipeline drugs will be developed with companion diagnostics.
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