A Medical Device Daily

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, DrPH, 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 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.”

Cytori Celution System okayed in Japan

Cytori Therapeutics (San Diego) reported receiving approval in Japan for its Celution System to be used in medical laboratories for stem cell collection and preservation procedures.

Green Hospital Supply (Tokyo), Cytori’s exclusive commercialization partner for the StemSource Cell Bank in Japan, expects to install the first hospital-based banks as early as 1Q08.

Kunihisa Furukawa, president of Green Hospital Supply, said, “Installing the StemSource Cell Bank will allow medical centers to become early adopters of regenerative medicine, expand and strengthen patient relationships, and grow revenue through an automated cell bank and storage annuity.”

The StemSource Cell Bank is a comprehensive onsite cell banking service, which includes the Celution System for automated cell processing plus all related equipment and software. Cytori said the cell bank “will provide patients with the first-ever opportunity to securely preserve their own adipose-derived stem and regenerative cells for potential future medical treatments.”

Seijiro Shirahama, senior VP, Asia Pacific, for Cytori, said, “This approval clears the way for Green Hospital Supply to begin hospital-directed commercialization activities. We received this approval well ahead of schedule and efforts to launch the cell bank are proceeding as planned.”

Datascope in Japanese distribution pact

USCI Holdings (Tokyo) and Datascope (Montvale, New Jersey) have entered into a distribution agreement for Datascope’s Intra Aortic Balloon Pumps (IABP) and Intra Aortic Balloon (IAB) catheters in Japan.

The accord gives USCI exclusive rights to distribute the currently approved CS100 IABP, prior pumps and future IABP technologies. USCI also will distribute Datascope IAB catheters, including those specifically designed for the Japanese market.

Datascope said USCI is “one of the premier medical device distribution organizations in Japan [and] provides Datascope with exceptional sales and service coverage from the southern island of Kyushu to the northern island of Hokkaido.” It said USCI has “especially strong service capabilities in the densely populated corridor that includes Tokyo, Nagoya and Osaka”

USCI Japan, a unit of USCI Holdings, has about 170 employees supporting its Japan operations. The company’s USCI Ireland R&D and manufacturing center in Ballinasloe, Ireland, employs another 60.

Michael Van Zandt, president/CEO of USCI Japan and COO of USCI Holdings, said, “This is a major step toward achieving our vision of becoming a global company for the global vasculature. Our holding group is quite strong in interventional cardiology, cardiac rhythm disease management and cardiac surgery.

Hepatitis test kits retail sale pact 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.