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Italy screen for cervical cancer with HPV test to

Digene : 14 June, 2007  (New Product)
Italy is the first country to launch a government sponsored cervical cancer screening programme by using the HPV test.
The HPV test is followed by cytology (Pap) for women who are found to carry the human papillomavirus (HPV) says Digene the company that is supporting the new programme.

The programme focuses on women living in Tivoli - an area just outside of Rome - and is organized by the Health Care Unit ASL Roma G, the largest local health unit in Italy.

The Digene HPV Test, which uses the company's proprietary 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 USA, 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 to 64 for high-risk types of the virus before administering a Pap.

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 paradigm of the future for cervical cancer screening.

In the pilot phase of the programme, 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'.

'It is 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'.

While the Pap relies on a laboratory technician to manually look for cell changes that may signal cervical disease, the Digene HPV Test uses advanced molecular technology to identify the presence of the genetic code (DNA) of 13 high-risk types of HPV.

Research shows that when used alone, the sensitivity of cytology is highly variable, ranging from 50 to 85 percent.

In contrast, the sensitivity of the Digene HPV Test has been proven in large-scale clinical trials to be 95 to 100 percent.
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