QIAGEN HPV DNA test donation to expand access to cervical cancer screening for women in rural India
Washington, DC, June 7, 2010 - QIAGEN today announced a key allocation from the company's "one million test" donation program to increase access to HPV screening for cervical cancer prevention among women in low-resource regions of the world. Approximately 26,000 human papillomavirus (HPV) tests will go to the Nargis Dutt Memorial Cancer Hospital for cervical cancer screening, the company said at the Women Deliver global advocacy conference in Washington DC, which is focused on promoting global maternal health solutions.
"We are hopeful that by demonstrating the potential of HPV testing, and by making 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," said QIAGEN Chief Executive Officer Peer Schatz. QIAGEN is planning future donation allocations and is currently collaborating with globally-regarded researchers, NGOs and Ministries of Health to provide HPV test donations for large-scale demonstration programs in Asia, India, Africa and other regions with high disease burden. HPV testing identifies women with high-risk HPV DNA infections that can cause cervical cancer, enabling diagnosis and treatment to be put in place before cervical cancer develops.
The Nargis Dutt Memorial Cancer Hospital is the hospital in Barshi, Maharashtra, India that counseled, screened and treated women as part of a landmark International Agency for Research on Cancer (IARC)-led study in 130,000 women, which demonstrated that, in low-resource settings, a single round of HPV testing significantly reduced the numbers of advanced cervical cancers and deaths, compared with Pap (cytology) testing or visual inspection with acetic acid (VIA). The IARC trial, led by Dr. Rengaswamy Sankaranarayanan, was designed to assess the effectiveness of various cervical cancer screening technologies in reducing cervical cancer incidence and death rates.
Following the April 2009 publication of study results in The New England Journal of Medicine, QIAGEN announced a donation of one million HPV tests to low-income countries over five years. The control group in the study had no screening, which is the standard of care in many parts of India. With the donated tests from QIAGEN, the women in the control group will now be able to access the best-performing cervical cancer prevention tool in the trial - QIAGEN's digene HPV test (also known as the Hybrid Capture 2 HPV DNA Test).
"India bears one-fifth of global cervical cancer burden, with approximately 134,000 new cases a year. In fact, the disease is reported to be responsible for almost 25 percent of all female cancer deaths here - and the burden is highest in our rural areas," said Dr. B.M. Nene, Chairman of the Tata Memorial Centre Rural Cancer Project at Nargis Dutt Memorial Cancer Hospital. "The IARC study that our hospital participated in demonstrated that the incidence of advanced cervical cancer and deaths are actually reduced - and hence lives saved - when HPV DNA screening is used. With this donation, the women in the control arm who were not screened - as is the ‘standard of care' in much of India - will now have the opportunity to be screened for cervical cancer with QIAGEN's donated HPV tests, which was shown in the trial to most significantly reduce cervical cancer incidence and mortality."
Broadening access to HPV DNA testing
QIAGEN's donations build 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 focused on improving health by providing access to screening methods for infectious diseases in 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 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.
To ensure that HPV testing can reach women in low-resource regions of the world, such as rural India, QIAGEN is working with PATH 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. Funded by the Bill & Melinda Gates Foundation, the careHPV test, currently in development, 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 may need treatment the same day.
QIAGEN's current "gold standard" HPV test platform - the digene HPV Test - uses advanced molecular diagnostic technologies to identify the presence of the genetic code (DNA) of the key high-risk, cancer-causing types of HPV. In the U.S., it 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 and as a post-cervical cancer treatment follow-up.
Cervical cancer causes nearly 274,000 deaths every year, 88 percent of which are in developing countries. According to IARC Globocan 2008 statistics, of the 529,000 cervical cancer cases reported each year, 293,000 originate from Asia. The WHO 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. Since the cause of cervical cancer - HPV - is known, it is a highly preventable and treatable disease if women have access to organized prevention programs.
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 bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay 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 a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs more than 3,500 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.