First Published Study of New HPV Test for Developing Countries Shows High Accuracy in Predicting Cervical Disease
QIAGEN's careHPV test provides ‘substantially more accurate' front-line screening
Venlo/ The Netherlands - September 22, 2008 - A new HPV test developed by QIAGEN specifically for use in regions of the world with scarce resources is "substantially" more accurate in identifying women with cervical disease than the current methods (Pap testing and visual inspection) in these countries. The first published study of patient outcomes with QIAGEN's careHPV test - developed with support from PATH, a non-profit global health organization - appears in the October issue of Lancet Oncology.
The new test for HPV (human papillomavirus), the primary cause of cervical cancer, is being developed by QIAGEN NV (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) in partnership with PATH, which receives funding for this project from the Bill and Melinda Gates Foundation. The careHPV test is specially designed to allow women in areas with scarce healthcare resources to benefit from the advanced technology of HPV testing: It produces rapid, accurate results, yet is also simple to run, requires minimal infrastructure and will be affordable for public-health programs in these countries. The product expected to available for pilot programs early in 2009 and more widely in the second half of that year.
"QIAGEN is rapidly expanding our leadership position in molecular diagnostics in the developed world, and we take very seriously our commitment to make improvements in life possible for everyone, no matter what their socioeconomic status," says Peer Schatz, CEO of QIAGEN. "While it is relatively common for healthcare companies to provide their products at reduced prices or simplified form for low-income populations, QIAGEN has gone further. QIAGEN has adapted the most advanced technologies to develop a new molecular HPV DNA test that achieves high performance targets, yet can be made available to under-served regions at a very affordable price."
The first published study of patient outcomes with careHPV involved more than 2,500 women age 30-54 in mostly rural areas of China. In developed regions with established public health budgets and programs, Pap testing (cytology) is the standard screen for cervical disease, supplemented by HPV testing in women over the age of 30 (who are most at risk). However, both the Pap and the current HPV test require "a level of infrastructure unattainable in most of the developing world," write the paper's authors. Thus, the most common cervical cancer screening tool in low-resource regions of China and similar countries has been visual inspection with acetic acid (VIA) - a procedure in which a woman's cervix is painted with vinegar to highlight any abnormal areas present, then visually examined by a doctor or nurse. However, VIA misses a significant number of women with cervical disease who need treatment: In the study published in Lancet Oncology, the "sensitivity" of VIA (its ability to identify women who have moderate or severe cervical disease, also called CIN2+) was 41 percent. In contrast, the sensitivity of careHPV was 90 percent when samples of cervical cells collected by healthcare workers were used, and 81 percent when women used a vaginal "self-sampling" device. In this study, careHPV was more sensitive even than the newer, liquid-based Pap testing, for which the sensitivity was 85 percent when the sample was collected in the in doctor's office. Pap testing, which requires trained technicians to interpret, is the primary screening tool in many countries.
The careHPV test can be conducted by workers with minimal healthcare training and education. Once collected, samples of vaginal or cervical cells are prepared for analysis using a kit of reagents that contains its own water supply. The testing itself is conducted on easily portable equipment and will run on batteries.
"In countries with scarce resources, women often live in environments with few amenities or healthcare staff. In this study, the careHPV test was effectively run by inexperienced, newly trained, minimally educated technicians under difficult conditions of temperature, humidity, lighting and space," said Attila Lorincz, PhD, senior author of the study and a professor of molecular epidemiology at Barts and the London School of Medicine, as well as London's Queen Mary College. "Another advantage of careHPV is that it can produce results within two and a half hours, allowing treatment to be administered during the same visit - a critical requirement when women would likely not be able to return for follow-up care if sent home after their exam."
Cervical cancer affects nearly 500,000 women around the world every year and kills more than 250,000 - of which 80 percent are in developing countries. "The careHPV test represents a significant advance in our effort to prevent cervical cancer in developing countries, where the burden is greatest and the most women die," says Chris Elias, President of PATH. "We must work together with governments, donors, public health programs and stakeholders to ensure that, once approved, this new tool reaches women without delay and saves lives."
About HPV and cervical cancer (http://www.thehpvtest.com/)
Worldwide, cervical cancer affects nearly 500,000 women annually and, after breast cancer, is the second-most-common malignancy found in women. Cervical cancer is caused by "high-risk" types of the human papillomavirus (HPV), which are sexually transmitted. It's estimated that 80 percent of women will get an HPV infection at some point in their lives. However, in most cases, the infection goes away or is suppressed by the body without causing problems. It is only infections that persist that can cause abnormal cells to form that may develop into cervical cancer if not detected and treated early. One report from the World Health Organization estimates that only about 5 percent of women had been screened for cervical disease in the previous five years, compared to 40-50 percent in the developed world.
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 only FDA-approved test for human papillomavirus (HPV), the primary cause of cervical cancer. QIAGEN employs more than 2,800 people in over 30 locations worldwide. Further information about QIAGEN can be found at http://www.qiagen.com/.
Certain of the statements contained in this news release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, markets, strategy or operating results are forward-looking, such statements are based on current expectations that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations and risks of dependency on logistics), variability of operating results, the commercial development of the applied testing markets, clinical research markets and proteomics markets, nucleic acid-based molecular diagnostics market, and genetic vaccination and gene therapy markets, competition, rapid or unexpected changes in technologies, fluctuations in demand for QIAGEN's, products (including fluctuations due to the level and timing of customers' funding, budgets, and other factors), our ability to obtain regulatory approval of our infectious disease panels, difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products, the ability of QIAGEN to identify and develop new products and to differentiate its products from competitors' products, market acceptance of QIAGEN's new products and the integration of acquisitions of technologies and businesses. For further information, refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).