Roche Seeks Label Expansion for Test

Zacks

Roche (RHHBY) recently announced that it has submitted a Premarket Approval (PMA) supplement to the US Food and Drug Administration (:FDA) for its cobas Human Papillomavirus (:HPV) test.

The company is looking to get the test approved for an additional indication.

Roche is seeking an additional cervical cancer primary screening indication for the test.

Approval for the above mentioned indication will enable the use of the cobas HPV test as a first-line test to screen patients for cervical cancer rather than using Pap cytology.

The PMA was filed based on a new three-year follow-up data from the ATHENA study wherein more than 47,000 women were screened for cervical disease with Pap and HPV tests in the US.

The FDA had approved the cobas HPV test in Apr 2011 for the screening of patients 21 years of age and above with abnormal Pap test results and to co-test with Pap in women between 30 and 65 years of age to assess the presence or absence of high-risk HPV genotypes.

We note that Roche provides tests for the detection of HPV, chlamydia and gonorrhea (CT/NG) along with genotyping of HPV to identify high-risk HPV types which are known to be associated with progression to cervical cancer.

Apart from providing therapeutic products and services for diverse medical needs, Roche continues to focus on innovative diagnostic solutions for the early detection and treatment of diseases.

Roche launched 55 major products in key markets in its diagnostics division in 2012. The product launches included advances in lab automation, patient testing and diabetes management coupled with expansion of the existing test menus.

We note that Roche’s diagnostics segment accounted for 22.5% of total sales in 2012 with a 4% increase in sales.

We are encouraged by Roche’s efforts to broaden its diagnostics portfolio. Roche invested CHF 900 million in 2012 to develop its technologies and products.

Roche plans to launch 13 different solutions in 2013, out of which 5 were launched in the first quarter of 2013.

We note that Abbott Labs’ (ABT) RealTime High Risk HPV molecular diagnostic test also enables detection of HPV which is the prime cause of cervical cancer.

Roche currently carries a Zacks Rank #4 (Sell). Right now, Valeant Pharmaceuticals (VRX) and Santarus, Inc. (SNTS) look attractive, each with a Zacks Rank #1 (Strong Buy).

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