Amy MacIver, 206.302.4522, email@example.com.
Seattle, November 28, 2012—China’s State Food and Drug Administration (SFDA) recently approved QIAGEN’s careHPV™ test for sale. Developed jointly with PATH, an international, nongovernmental organization, careHPV, which is produced in China, will be sold in that country by January 2013. The test is likely to become available in India later in the year, with other countries to follow.
The long awaited announcement means that low-resource countries, which largely have not been able to mount successful, national cervical cancer screening and treatment programs, soon will have a new option.CareHPV provides results more rapidly than other DNA tests and is designed especially for use in clinics that lack reliable clean water or electricity.
CareHPV detects the DNA of 14 different types of the human papillomavirus (HPV) that cause cervical cancer. HPV is a very common infection, especially among younger women with about 10 percent of HPV-infected women developing cervical precancer. If the condition is not treated, about 10 percent of those women will suffer from cervical cancer, a fatal disease.
Eighty-eight percent of women who die from cervical cancer live in Africa, Asia, and Latin America. But it was not always that way. During the first half of the 20th century cervical cancer deaths were common worldwide. However, widespread use of Pap smears to detect cervical precancer in the United States, Europe, and other wealthy countries caused rates to fall dramatically in those countries since the 1950s.
Unfortunately, Pap is complex and requires high-quality laboratories and highly skilled staff; for those reasons it has rarely been a success in less-developed areas. Also, Pap misses many precancer cases, so it works best when women are screened every couple of years, something low-income countries cannot afford.
PATH’s research in India, Nicaragua, and Uganda has shown that careHPV can be effectively used even in very basic clinics and that it indicates much higher sensitivity than Pap or other methods (i.e.,careHPV detects more infection with HPV).
Over the past decade, many low-resource countries have introduced a low-cost, relatively simple test called “visual inspection with acetic acid” or VIA (using acetic acid—vinegar—the same vinegar commonly used in salads and other foods). But like Pap, VIA only identifies about 50–60 percent of precancerous cases. CareHPV detects many more cases. When precancer is found and treated early, cure rates tend to be excellent.
CareHPV works well with samples taken from the cervix by doctors and nurses during pelvic examinations. It shows nearly the same sensitivity with vaginal samples taken without a pelvic exam. The PATH studies found that vaginal sampling is an attractive option for many women mainly because pelvic exams are uncomfortable and may be embarrassing.
Some health care professionals initially were skeptical of vaginal sampling, but they quickly began to see its potential for dramatically increasing the ability of a clinic to collect and process many samples in a cost-effective, and rapid, manner. If the new test were used broadly, millions of women could be screened and those with precancer promptly treated, preventing deadly cervical cancer later in life.