QIAGEN’s careHPV test provides more accurate screening

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 is expected to be 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.

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.”

Source: QIAGEN NV, USA

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