QIAGEN receives CE conformity marking for careHPV Test

QIAGEN (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) has completed European certification of its careHPV™ Test to bring human papillomavirus (HPV) testing to public-health programs in low-resource, developing countries, the company announced today at the International Papillomavirus Conference in Montreal, Canada. The CE conformity marking ("Conformite Europeenne") certifies that the careHPV Test has met European Union consumer safety and health requirements, allowing the test to be distributed in developing countries that recognize the CE mark.  

"The CE marking of our careHPV Test now allows us to prepare for the distribution phase of this innovative new test in low-resource settings of developing regions – such as India and countries in Africa – that recognize the CE mark. This milestone represents a significant step forward for broadening access to cervical cancer screening and HPV testing to areas of the developing world that bear the highest burden of cervical cancer," said QIAGEN CEO Peer Schatz. "We are hopeful that by working with the public health community to make our state-of-the-art screening technologies more accessible in underserved areas, we can play a role in reducing the global burden of cervical cancer."

In addition to the CE mark, QIAGEN will pursue World Health Organization (WHO) prequalification – an approval process that allows United Nations (UN) agencies to purchase diagnostic technologies for low income countries. The company is also preparing the submission of its careHPV marketing application to the Chinese State Food & Drug Association (SFDA).  

HPV testing identifies women with high-risk human papillomavirus (HPV) infections that can cause cervical cancer, enabling diagnosis and treatment before cervical cancer develops. While QIAGEN's digene® HPV Test (also known as the Hybrid Capture® 2 High-Risk HPV Test) represents the "gold standard" for HPV screening and is the most efficient and effective solution for laboratory-based testing, the careHPV test makes HPV DNA testing simple, effective and affordable for women in low-resource settings.  The careHPV Test can be performed by a healthcare worker in a community facility without mains electricity or running water and offers HPV detection results in a matter of hours – a critical characteristic for women traveling long distances to clinics and for those women who can benefit from treatment during the same visit.

For low-resource regions in the developing world, QIAGEN will work with countries individually to enable access to QIAGEN's entire product portfolio of clinically-validated HPV test solutions, including the digene HPV Test and the careHPV Test.  QIAGEN will collaborate with the local experts and public health authorities who will take the lead on the development and implementation of the country's cervical cancer screening program.  Accessibility and affordability will be addressed by leveraging a tiered-pricing strategy for all of QIAGEN's HPV tests, based on a country's economic status, test volume commitments, and ability to implement a sustainable HPV based screening program.  

For urban areas in the developing world, and for industrialized countries with established laboratories and a robust healthcare infrastructure, QIAGEN is developing the QIAensemble™ system, a next-generation HPV DNA testing platform with enhanced instrumentation and automation to increase the speed, volume and testing menu of the company's leading Hybrid Capture 2 system.  With the careHPV Test, the digene HPV Test and the new QIAensemble platform, QIAGEN will have HPV DNA testing solutions customized for settings ranging from rural health clinics with no electricity to sophisticated, high-throughput labs running thousands of HPV tests per day. Posters on QIAGEN's HPV testing technologies presented at the International Papillomavirus (IPV) conference include:

  • QIAensemble 2000: A next-generation high-throughput platform for a broad menu of tests including a new generation of Human Papillomavirus DNA Assays - abstract
  • Hybrid Capture assay performance of liquid-based cytology specimens after sample preparation by the automated QIAensemble SP - abstract
  • An HPV genotyping assay that utilizes QIAGEN Hybrid Capture technology - abstract
  • Introduction of careHPV in rural Nigeria: Methodologic lessons and analysis of performance - abstract
  • Performance of careHPV testing, VIA, and cytology in the START-UP demonstration project in Nicaragua - abstract

Cervical cancer and HPV testing

Cervical cancer causes nearly 274,000 deaths every year, 88 percent of which are in developing countries. The World Health Organization estimates that only about 5 percent of women in the developing world have been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world.  Because of limited screening and low coverage, there has been no significant reduction in the incidence of cervical cancer in the developing world during the past three decades. However, research has shown that in low resource settings, a single round of HPV testing significantly reduces the numbers of advanced cervical cancers and deaths. Since the cause of cervical cancer – HPV – is known, it is preventable and treatable disease if women have access to organized prevention programs.

In the U.S., the digene HPV Test is approved to be used together with a Pap test in women 30 years and older. In Europe, it is approved as an initial general population screening test either alone or together with a Pap test.  It is also used as a follow-up to inconclusive Pap test results.  

Broadening access to HPV DNA testing

QIAGEN recognizes that addressing cervical cancer is important to maternal health and aims to increase access to HPV testing and cervical cancer prevention technologies for women worldwide through QIAGENcares, a corporate social responsibility program focused on improving health by providing access to screening methods for infectious diseases in underserved parts of emerging and developing countries.  Current commitments include HPV test donation programs, development of next generation HPV technologies, tiered-pricing initiatives and on-the-ground pilot cervical cancer screen-and-treat projects.  In addition, QIAGEN announced a partnership with Merck & Company, Inc. in 2009 focused on increasing access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world, the first time a vaccine manufacturer and a molecular diagnostics company are collaborating to address the burden of cervical cancer with a comprehensive approach.

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