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New HPV test for developing countries shows high accuracy in predicting cervical disease: Study

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."

QIAGEN