Label Expansion for Roche's HPV Test


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Roche (RHHBY) recently announced that the U.S. Food and Drug Administration (:FDA) has approved its cobas Human Papillomavirus (:HPV) Test for use as a first-line primary screening test for cervical cancer in women aged 25 and above.

The approval was expected as the FDA’s Microbiology Devices Panel of the Medical Devices Advisory Committee unanimously recommended in favor of the cobas HPV Test in Mar 2014.

We note that Roche's cobas HPV Test received FDA approval in Apr 2011 for screening patients of 21 years and above with abnormal cervical cytology results. The test is also approved for use adjunctively with normal cervical cytology in women aged 30 and above to assess the presence or absence of high-risk HPV genotypes.

Roche's cobas HPV Test provides both pooled high-risk HPV DNA results and individual detection of HPV 16 and HPV 18. These two types of HPV are responsible for about 70% of cervical cancer.

We remind investors that Roche submitted its Premarket Approval (:PMA) supplement for the cervical cancer primary screening indication to the FDA in Jun 2013.

The label expansion was based on positive results from the ATHENA trial (n=47,000) in women. The results from the trial included a comparison of a cobas HPV Test screening strategy to alternative strategies using Pap cytology and HPV testing. The comparison showed that a strategy leveraging the ability of the cobas HPV Test to identify women testing positive for HPV 16 or 18, and using cervical cytology (Pap) as a triage, follow-up test to enable clinicians to detect the disease more efficiently.

Roche has a broad portfolio of diagnostic tests with more than a hundred high-quality Elecsys assays for immune testing along with a new generation of fully automated cobas analyzers for improved medical decision making, scheduling and efficiency.

We are encouraged by Roche’s efforts to strengthen its Diagnostic Division. The Diagnostics Division generated sales of $10.5 billion in 2013, up 4% from a year ago. The introduction of new tests will further boost the sales of this division.

Roche currently carries a Zacks Rank #3 (Hold). Right now, stocks like Allergan (AGN), Johnson & Johnson (JNJ) and Salix Pharmaceuticals (SLXP) look attractive. All carry a Zacks Rank #1 (Strong Buy).

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