Market Overview

QIAGEN's careHPV™ Test Wins WHO Prequalification Status for Cervical Cancer Screening


WHO Prequalification recognizes the important role that the careHPV
Test can have in screening women in emerging countries for HPV

QIAGEN N.V. (NYSE:QGEN, Frankfurt Prime Standard: QIA)) today announced
that its careHPV™ Test, one of the only molecular diagnostics for
high-risk human papillomavirus (HPV) designed to screen women in
low-resource settings, has been added to the World Health Organization
(WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the
primary cause of cervical cancer, so screening women for the presence of
the virus is a critical aspect for prevention and early treatment of the
deadly cancer. The careHPV Test was launched globally in
2010 and through numerous pilot studies has demonstrated to be a more
sensitive alternative to cytology and visual inspection based methods
for the detection of pre-cancerous cell abnormalities. The WHO's
evidence-based listing is expected to expand the availability of this
critical diagnostic tool in countries that rely on the global
organization's list in making purchasing decisions. The WHO
Prequalification status will significantly broaden access to HPV DNA
testing to areas of the world with a high burden of cervical cancer.

"The WHO prequalified IVD listing is a ‘stamp of approval' for our
innovative careHPV Test, and this will encourage authorities to
adopt efficient, highly accurate HPV screening for prevention of
cervical cancer in settings with limited healthcare infrastructure,"
said Thierry Bernard, Senior Vice President, Molecular Diagnostics
Business Area, for QIAGEN. "China routinely uses careHPV in rural
or low-resource areas, and QIAGEN partners with non-governmental
organizations and health ministries in developing countries. We expect
the WHO listing to drive further dissemination of this important tool
for women's health."

Please find the full press release here

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