A Medical Device Daily

Digene (Gaithersburg, Maryland) reported that Italy has become the first country to launch a government-sponsored cervical cancer screening program using the HPV test as a frontline diagnostic tool, followed by Pap test cytology for women who are found to carry the human papillomavirus (HPV).

The program, organized by the healthcare unit ASL Roma G , the largest local health unit in Italy, focuses on women living in Tivoli, outside of Rome.

The Digene HPV Test, which uses the company's Hybrid Capture II (hc2) technology, is the only test for detecting the presence of high-risk types of HPV, the cause of cervical cancer, that is clinically validated and both FDA-approved and CE-marked.

In the U.S., it is approved for routine use along with a Pap in women age 30 and older. However, since clinical evidence has shown that HPV infection is necessary for the development of cervical cancer and that HPV testing can identify women at risk for developing the disease, Roma G has decided to test women age 25-64 for high-risk types of the virus before administering a Pap test.

A number of medical experts, including the authors of a recent consensus paper on HPV published in the journal Vaccine, have predicted that this is the of the future direction for cervical cancer screening.

In the pilot phase of the program, 26,000 women in the targeted age range who live in the jurisdiction of the Roma G unit are being recruited for HPV testing via a letter and educational information. Once the pilot is complete and outcomes are assessed, primary HPV screening will be considered for expansion to all eligible women in the area.

"The [Italian] Public Health Agency has identified our ASL Roma G unit as the pilot center for the first use of the HPV test as a first-level screening tool," said Dr. Maria Concetta Tufi, who is responsible for the screening program of ASL Roma G. "It is a unique approach not only for Italy but for the whole world."

She added, "It's an innovation destined to radically change the approach to cervical cancer prevention, with an ambitious objective to eliminate a disease that kills approximately 300,000 women around the world ever year, including 2,000 in Italy."

The Digene HPV Test uses molecular technology to identify the presence of the DNA of 13 high-risk types of HPV. The company said research has shown that when used alone, the sensitivity of Pap cytology is highly variable, ranging from 50% to 85%. In contrast, it said the sensitivity of the Digene HPV Test has been proven in large-scale clinical trials to be 95% to 100%.

3D system used in videothoracoscopic surgery

Viking Systems (San Diego) said its 3Di Vision System had been used for the first time to perform videothoracoscopic surgery. Three procedures — a parietal pleurectomy, a sublobar resection and a chemical pleurodesis — were performed with the 3-D visualization technology at the Regional Oncologic Hospital (Rionero, Italy) by Dr. Cosimo Lequaglie.

Lequaglie, chief of oncologic and thoracic surgery at the hospital, said Viking's 3Di Vision System "provides a more substantial and effective image than those we traditional obtain via 2D vision systems." He said the "higher resolution [and] stereoscopic depth we are now afforded allows the same type of confidence we are usually only allowed during open procedures."

The Viking system also includes an information management solution known as Infomatix, which provides immediate, picture-in-picture access for a surgeon to additional surgical information through voice activation. The company said the information can be provided simultaneously with the surgical video via picture-in-picture on the surgeon's personal head display.

Lequaglie used that feature, saying later, "The ability of the system to provide both a high-definition 3D image and pre-existing medical data into one personal head display finally offers the kind of support a surgeon needs to allow greater precision and speed without being bound to the positioning of the monitors in the room."

Stephen Heniges, Viking's senior VP of global marketing and clinical development, said the results Lequaglie and his team achieved through the company's technology "provides motivation to all minimally invasive thoracic surgeons worldwide."

The 3Di Vision System has an initial focus on applications in urology, gynecology, bariatrics and general surgery.

Virtual colonoscopy products released

Viatronix (Stony Brook, New York), a developer of diagnostic 3D imaging software, and Medicsight (London), a developer of computer-aided detection (CAD) technologies, reported the European commercial release of their integrated "virtual colonoscopy" products with CAD.

Medicsight presented the integrated solution at the annual congress of the European Society of Gastrointestinal and Abdominal Radiology in Lisbon, Portugal, last week.

The Viatronix V3D-Colon, integrated with Medicsight's CAD system for performing virtual colonoscopy, has received the CE mark. The integrated Viatronix system aids physicians in the early detection and identification of polyps and has been tested at more than 25 sites across Europe, according to the company.

"The integrated products provide additional tools, to improve the speed and efficiency of radiologists' workflow," said Zaffar Hayat, president of Viatronix.

Medicsight CEO David Sumner said, "We are confident that the integrated solution will create an ideal workflow and optimize reading times for end user productivity, giving Viatronix and Medicsight the opportunity to capitalize on the ever increasing customer demand for virtual colonoscopy with CAD."

The Viatronix V3D-Colon allows physicians to interactively view the colon as reconstructed from a computed tomography (CT) scan, providing visualization of the entire colon where polyps or other lesions may be located.

Viatronix said it is the only system on the market that is backed by a multi-center clinical trial showing 93.9% sensitivity and 92.2% specificity for adenomatous polyps sized 8 mm and larger.

Medicsight ColonCAD API is an image-analysis software tool designed to be used with CT colonography scans to assist radiologists in detecting and measuring potential colorectal polyps. ColonCAD is integrated within the advanced 3D visualization and picture archiving and communications system platforms of various imaging equipment partners.

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