) 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
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
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
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
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
) 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,
) look attractive, each with a Zacks Rank #1 (Strong Buy).
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