Roche (RHHBY) recently received encouraging news when the U.S. Food and Drug Administration (FDA)’s Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously in favor of the cobas HPV (Human Papillomavirus) Test.
The panel recommended that the benefits of Roche’s cobas HPV test as a first-line primary screening tool in women (aged 25 years and above) for assessing their risk of cervical cancer outweigh the risks. The test is based on the presence of clinically relevant high-risk HPV DNA.
The panel also voted unanimously in favor of cobas HPV Test being safe and effective for the proposed indication.
We note that the results from the ATHENA study (n=47,000) showed that a significant number of women would benefit by using the cobas HPV Test as primary screening for cervical cancer.
We remind investors that the FDA is not bound by the Advisory Committee's recommendation for its review of the primary screening indication for the cobas HPV Test.
Roche is a specialist in drugs for oncology, immunology, and infectious diseases. Apart from providing therapeutic products and services for diverse medical needs, Roche also focuses on innovative diagnostic solutions for the early detection and treatment of diseases.
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). Some better-ranked stocks include Shire (SHPG), Questcor Pharmaceuticals (QCOR) and Salix Pharmaceuticals (SLXP). All three carry a Zacks Rank #1 (Strong Buy).
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