A Diagnostics & Imaging Week

The first randomized, controlled study in North America of HPV testing as a stand-alone screen concluded that it is almost 40% more accurate than the traditional Pap smear in identifying women with advanced cervical disease, according to a report published in the New England Journal of Medicine.

The study, which involved more than 10,000 Canadian women ages 30 to 69, found that the HPV test’s sensitivity — its ability to accurately identify women with pre-cancerous cervical cells or cancer — was 94.6%, compared to 55.4% for the Pap smear. HPV (humanpapilloma virus) is the primary cause of cervical cancer.

“We already knew before conducting this study that the sensitivity of the Pap left a lot to be desired,” said one of the study’s authors, Eduardo Franco of McGill University (Montreal). “However, 55.4% accuracy is only slightly above chance.”

The study used Qiagen’s (Amsterdam, the Netherlands) Hybrid Capture 2 High-Risk HPV DNA test — the only such test both CE-marked and FDA-approved. The molecular diagnostic test was developed by Digene (Gaithersburg, Maryland), now part of Qiagen.

The company said the performance of the test has been validated in studies that included more than 300,000 women.

Participants in the Canadian Cervical Cancer Screening Trial (CCCaST) were randomly assigned to a “focus on Pap” or “focus on HPV” screening group; for ethical reasons, both groups received both tests. In the study, conventional cytology was used. All CCCaST participants who tested positive on either the Pap or HPV test were referred for a follow-up biopsy.

In addition to the HPV test’s greater sensitivity, the study found that its specificity — the likelihood that women with positive results actually have the disease — was slightly less than the Pap smear’s (94.1% vs. 96.8%).

Qiagen said that HPV testing for routine cervical cancer prevention is currently most widely practiced in the U.S., where it is approved for use along with a Pap test in women age 30 and over. Under the currently recommended guidelines, screening that includes HPV testing may be performed at longer intervals than when the Pap is used alone.

However, the NEJM report authors concluded that co-testing “only marginally improved sensitivity compared with HPV testing alone. We believe that a shift from cellular to viral [screening] tests, coupled with education and vaccination, will contribute to more efficient control of cervical cancer.”

The Oct. 4 issue of The Lancet reported on a trial involving more than 17,000 women in the Netherlands. That study, led by Chris Meijer, MD, of VU Medical Center (Amsterdam), concluded that HPV DNA testing detects pre-cancerous cervical cells earlier than the traditional Pap, thus allowing longer intervals between screenings.

Qiagen said this is an important feature for health authorities working to control costs, “particularly those in developing countries, where a variety of obstacles make it difficult for women to access regular medical care.”

Hepatitis test kits at retail sale in SE Asia

Medical Services International (MSI; Edmonton, Alberta) said it has agreed to supply VScan Hepatitis B & C test kits for retail sales in Southeast Asia through retail pharmaceutical outlets.

MSI said it projects that it will sell up to 50,000 hepatitis test kits in the first year.

The company said that the World Health Organization (Geneva) estimates the number of people with hepatitis C, but don’t know they have it, at more than 200 million and increasing each year.

“Having access to a hepatitis test kit where an individual can test himself in private will be a substantial help to controlling the spread of the disease,” the company said in a statement.