Landmark Study In The New England Journal Of Medicine Shows HPV Testing Significantly Reduces Deaths From Cervical Cancer

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Apr 2009 - 6:00 PDT

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Results from an eight-year trial involving more than 130,000 women published in The New England Journal of Medicine (NEJM) demonstrate that in low-resource settings a single round of HPV testing significantly reduces the numbers of advanced cervical cancers and deaths, compared with Pap (cytology) testing or visual inspection with acetic acid (VIA). The trial used QIAGEN's (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA) digene HPV Test, which detects high-risk types of human papillomavirus that cause cervical cancer.

"The implications of the findings of this trial are immediate and global: international experts in cervical-cancer prevention should now adapt HPV testing for widespread implementation," wrote Drs. Mark Schiffman and Sholom Wacholder of the U.S. National Cancer Institute in an editorial that accompanied the study in the NEJM. "The remarkable promise of the Indian trial presents a worthy global challenge to implement smart, regionally tailored strategies that will efficiently save millions of lives in the years ahead."

Following this milestone study, over the next five years QIAGEN will donate one million HPV tests, with a total estimated value of over US$30 million (based on U.S. list prices), as part of its broader global access program to provide the highest quality cervical cancer screening technologies to women in developing countries. Nearly 300,000 women die of cervical cancer every year, with 80% of deaths occurring in developing countries.

QIAGEN's commitment to expanded access to HPV screening includes:

-- HPV test donation programs, in partnership with leading public health institutions and health non-governmental organizations (NGOs)

-- Development of next-generation HPV technologies, including the careHPV test - designed specifically for low-resource, developing countries

-- Tiered-pricing initiatives for low-resource countries

"This landmark study further validates the value of QIAGEN's HPV test as the gold standard for cervical cancer screening and demonstrates that the incidence of advanced cervical cancer and deaths are actually reduced -- and hence lives saved -- when HPV screening is implemented," said Peer Schatz, Chief Executive Officer of QIAGEN. "QIAGEN's HPV testing technology is already being used to routinely screen millions of women in the United States and Europe. We're committed to working together with the public health community to ensure that women everywhere have access to the best cervical cancer prevention tools." Moving forward QIAGEN will collaborate with a team of global health partners -- including the International Planned Parenthood Federation and Jhpiego, an international non-profit health organization affiliated with Johns Hopkins University -- on the administration of the donation program.

Led by Dr. Rengaswamy Sankaranarayanan of the International Agency for Research on Cancer (IARC), the randomized, controlled trial compared the efficacy of three methods of cervical cancer screening: VIA, Pap testing (cytology) and HPV testing with QIAGEN's hybrid capture 2 (hc2) DNA testing technology (called the digene HPV Test). The study was conducted in the Maharashtra state of India, and was supported with funding by the Bill & Melinda Gates Foundation.

It is the first randomized controlled trial to measure incidence of cervical cancer and associated rates of death as the primary outcomes, using different tools for screening. In addition to being "associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer," QIAGEN's hc2 HPV testing platform "was the most objective and reproducible of all cervical cancer screening tests and was less demanding in terms of training and quality assurance," the study authors state. The study is posted to http://content.nejm.org.

QIAGEN broadens access to HPV testing

QIAGEN's donation of 1 million HPV tests builds upon the company's programs to increase access to HPV testing and cervical cancer prevention technologies for women worldwide through QIAGENcares, a corporate social responsibility program to improve the access to better screening methods for infectious diseases in emerging and developing countries. Current commitments include donation programs, development of next generation HPV technologies, tiered-pricing initiatives and on-the-ground pilot cervical cancer screen-and-treat projects.

To ensure that HPV testing can reach women in all regions of the world, QIAGEN is working with PATH and the Bill & Melinda Gates Foundation to develop a new version of its state-of-the-art HPV test -- to be called the careHPV test -- for public-health programs in low-resource, developing countries. The careHPV test, currently in development, can be performed without electricity or running water and offers HPV detection results in a matter of hours -- a critical characteristic for women traveling to clinics from isolated villages and for those women who may need to be treated the same day. Both QIAGEN HPV screening technologies -- careHPV and the digene HPV Test -- are expected to play a key role in reducing cervical cancer worldwide. Both will be included in the donation program.

As part of its on-the-ground programs, QIAGEN is preparing to launch a mobile cervical cancer screening clinic in India. India has more cervical cancer cases than any other country in the world and cervical cancer is the number one cause of cancer related death among women. Additionally, in China, QIAGEN is providing HPV testing products to 29 hospitals as part of a nationwide prevention campaign organized by the Cancer Foundation of China. For more information on QIAGENcares and the donation program, visit http://www.qiagen.com/QIAGENcares.

About the digene HPV test

QIAGEN's digene HPV Test is approved in the United States and Europe for use together with a Pap in women 30 and older. FDA-approved since 1999, the digene HPV Test has been published in more than 300 peer-reviewed journal articles and studied in clinical trials involving more than 825,000 women worldwide. More than 40 million tests for carcinogenic HPV have been performed with the digene HPV Test.

About HPV and cervical cancer

Worldwide, cervical cancer affects approximately 500,000 women annually and, after breast cancer, is the second-most-common malignancy found in women. Since the cause of cervical cancer -- HPV -- is known and women who have it can be identified, it is a highly preventable and treatable disease if women have access to organized prevention programs. However, 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. For more information about HPV and cervical cancer, visit http://www.theHPVtest.com.

About QIAGEN

QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated biomolecules visible. QIAGEN has developed and markets more than 500 consumable products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as the "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 3,000 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com

QIAGEN
http://www.qiagen.com

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