Italy Is First Country To Launch Government-Sponsored Cervical Cancer Screening Program Using HPV Test As Primary Diagnostic
June 14, 2007
Italy has become the first country to launch a government-sponsored cervical cancer screening program using the HPV test as the frontline diagnostic tool, followed by cytology (Pap) for women who are found to carry the human papillomavirus (HPV), Digene Corp. (Nasdaq: DIGE) announced today. The program 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(R) HPV Test, which uses the company’s proprietary Hybrid Capture(R) 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 United States, 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. 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 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. 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.”
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 50-85 percent. In contrast, the sensitivity of the Digene HPV Test has been proven in large-scale clinical trials to be 95-100 percent.
About Digene
A leader in molecular diagnostics, Digene develops, manufactures and markets proprietary DNA and RNA tests, with a focus on women’s health. The company’s flagship product, the Digene(R) HPV Test, is the only FDA-approved and CE-marked test for the human papillomavirus, the cause of essentially all cervical cancers. Digene’s product portfolio also includes tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea. Digene tests are marketed in more than 40 countries worldwide. Headquartered in Gaithersburg, MD, Digene is traded on Nasdaq under the symbol DIGE.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not guarantees of the future as there are a number of meaningful factors that could cause the company’s actual results to vary materially from those indicated by such forward-looking statements. Meaningful factors, which could cause actual results to differ from expectations include, but are not limited to, the degree of acceptance of HPV testing by physicians, uncertainty of the company’s future profitability, its ability to scale up manufacturing operations to meet any increased demand, the uncertainty regarding patents and proprietary rights, the success of the company’s marketing efforts, competition, risks inherent in international transactions, and the inability to obtain requisite additional financing, as well as other factors discussed in the company’s Securities and Exchange Commission filings. For other factors, reference is made to the discussion in the company’s annual and quarterly reports filed with the Securities and Exchange Commission.