Study Finds New Version of QIAGEN’s HPV Test for Developing Countries Could Reduce Risk of Cervical Cancer by More than Half When

Research Shows the New Test is Accurate, Simple to Run and Requires Minimal Resources

Beijing, (PresseBox) - Research demonstrating the potential of a special type of HPV test developed by QIAGEN with support from PATH – a non-profit global health organization – to reduce the incidence of cervical cancer in low-resource regions of the world were presented this week at the 24th International Papillomavirus Conference in Beijing, People’s Republic of China. An economic modeling analysis found that the "FastHPV" test, which is being developed specifically for cervical cancer screening in countries such as China and India, could reduce the incidence of cervical cancer by as much as 56 percent if given just three times over a woman’s life and combined with appropriate treatment. In addition, a clinical research study concluded that the FastHPV test produces rapid, accurate results, yet is also simple to run, requires minimal infrastructure and will be affordable for public-health programs in those countries.

FastHPV – a molecular test for cancer-causing types of HPV (human papillomavirus) – is under development by QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) in partnership with PATH. The test – on track to be submitted for its first regulatory approvals in countries like China and India in 2008 -- is specially designed to allow women in areas with scarce healthcare resources to benefit from the advanced technology of HPV testing.

"It is relatively common for healthcare companies to provide their products and services at reduced prices to countries with minimal healthcare infrastructure and large low-income populations," says Peer Schatz, CEO of QIAGEN. "With our new FastHPV test, QIAGEN has gone beyond that standard approach and has specifically adapted the HPV DNA test it sells in the developed world to meet the special needs of women and their healthcare providers in these very challenging settings. What is remarkable is that the FastHPV test uses advanced molecular diagnostic technology, yet is packaged into a solution that can be run in almost any environment and by almost any operator. QIAGEN is already the leader in molecular diagnostics in the developed world, but we take very seriously our commitment to make improvements in life possible for everyone, no matter what their socioeconomic status."

The FastHPV 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 kit’s stability has been demonstrated for more than eight months at room temperature, and conditions as extreme as 104 degrees F. – 40 degrees C. – can be tolerated for up to a month. The testing itself is conducted on easily portable equipment and will, when introduced, run on batteries.

Human papillomavirus is the primary cause of cervical cancer, which 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 High-Risk hc2 HPV DNA Test® developed by Digene Corp. (now part of QIAGEN) is emerging as a standard of care for identifying women at risk. In the United States, HPV testing has been approved by the U.S. Food and Drug Administration for use along with cytology (commonly called the Pap smear) in women 30 and over. However, the infrastructure (such as clean water and electricity) and trained personnel required for Pap smears are not usually feasible for low-resource regions.

In addition, in these regions, transportation and other obstacles prevent easy access to medical clinics, necessitating rapid availability of test results so that follow-up care – if needed – can be initiated quickly, ideally the same day. FastHPV has been designed to be used as a stand-alone diagnostic test to screen women for cervical cancer risk, producing results in less than two and a half hours.

The first clinical study of FastHPV to be reported, which was summarized at the conference in Beijing, was conducted as part of PATH’s Screening Technologies to Advance Rapid Testing (START) project. It involved more than 2,500 women age 30-54 in mostly rural areas of China, where the World Health Organization has found that diseases are the cause of poverty for up to half of the population. Because cytology is not practical in such regions, the most common cervical cancer screening tool has been visual inspection with acetic acid (VIA), in which the cervix is painted with vinegar to better highlight any abnormal areas present, then examined by a healthcare professional. However, in this study, VIA was not very accurate; its sensitivity (ability to identify women who have severe, pre-cancerous cervical disease) was only 41 percent. In contrast, the sensitivity of FastHPV was 86-90 percent when samples of cervical cells collected by healthcare workers were used, and 81 percent when women collected their own samples using a vaginal collection device.

"Unlike other cancers, cervical cancer has a single, known cause: HPV. That makes the disease highly preventable – if abnormal cells are found and treated early. This research clearly shows that the ability of FastHPV to accurately identify women with pre-cancerous cervical disease is substantially better than visual inspection and approaching that of the technology used for HPV DNA testing in high-resource countries (QIAGEN’s proprietary hc2 platform)," concluded Professor Youlin Qiao, who led the PATH-funded study and serves as Chief of the Department of Cancer Epidemiology at the Chinese Academy of Medical Sciences. "FastHPV is very promising as a realistic method for public-health cervical cancer prevention programs in low-resource settings like many areas of rural China."

In a separate presentation in Beijing, John Sellors, MD, Senior Medical Advisor at PATH and START project director, discussed the results of an economic model that projected the impact if women in low-resource countries were to be tested with FastHPV just three times in their lives – 5 years apart, after age 35. This analysis found that cervical cancer could be reduced by 30-56 percent, assuming that the majority of women participated and effective treatment is available. The best results would be achieved when using a "screen-and-treat" approach that allows women found to have the virus to be treated for possible disease in the same visit. Standard protocols in North America and Europe call for women with a positive HPV test to be re-screened later to confirm that the infection has not naturally resolved, and/or to confirm the presence of cervical disease with a biopsy. However, this is not feasible or affordable in low-resource settings, and many women would fail to return for the required follow-up visits.

Dr. Sellors and his colleagues add that while vaccination of adolescents against the most common types of HPV would be expected to reduce the incidence of cervical cancer even further, its cost-effectiveness will depend on price and the ability to ensure compliance with the necessary protocol, which currently calls for three shots over six months.

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