SAN DIEGO, November 21 /PRNewswire/ --
-- New, CE-Marked Molecular Assay May Help Identify Women with Cervical Cancer or Pre-Cancer More Accurately than Competing Technologies, Studies Show -
Gen-Probe's (Nasdaq: GPRO) CE-marked APTIMA(R) HPV assay may be an important new molecular tool to more accurately detect high-risk human papillomavirus (HPV) infections that are associated with cervical cancer or precancerous lesions, according to nine oral presentations and two scientific posters presented last week by independent and Gen-Probe researchers at the international conference of the European Research Organization on Genital Infection and Neoplasia (EUROGIN) in Nice, France.
Gen-Probe's APTIMA HPV assay has been CE-marked for sale in the European Union, and clinical trials of the test are underway in the United States. The assay has not been approved for marketing by the U.S. Food and Drug Administration.
"As a whole, these studies suggest that our new APTIMA HPV assay may detect high-risk HPV infections that have progressed, or are progressing, to cervical cancer more specifically than competing assays that simply detect whether HPV infection is present," said Dan Kacian, Ph.D., M.D., Gen-Probe's executive vice president and chief scientist. "Since most HPV infections resolve without causing cancer, more specific tests are needed to avoid unnecessary and invasive medical procedures and patient anxiety. Additional longer-term studies are needed and are underway, but these results give us continued confidence that our test may play an important role in helping protect women from both cervical cancer and the adverse effects of non-specific diagnosis."
In one key presentation at EUROGIN, Joseph Monsonego, M.D., EUROGIN scientific director, presented interim results of the French APTIMA HPV Screening Evaluation (FASE) study from 1,528 women. The study eventually will include 5,000 women between the ages of 20 and 65. In the study, liquid cytology samples were tested with the Gen-Probe APTIMA HPV assay and with Digene/Qiagen's Hybrid Capture(R) 2 assay, and the results were compared to the gold standard of histology (microscopic analysis of cervical tissue).
Dr. Monsonego concluded that in the study to date, the APTIMA HPV assay had statistically identical sensitivity, but higher specificity, than the Hybrid Capture 2 test. Other studies of the APTIMA HPV assay presented at EUROGIN showed similar results in geographically and clinically diverse patient groups. Additional details on these studies can be found in the "Science" section of the Gen-Probe website at http://www.gen-probe.com/global/science.
About the APTIMA HPV Assay
The APTIMA HPV assay is an amplified nucleic acid test that detects 14 high-risk HPV types that are associated with cervical cancer. More specifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, that are made in higher amounts when HPV infections progress toward cervical cancer. Gen-Probe believes targeting these mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA. Detecting HPV DNA identifies women who are infected, but HPV infections are common and most resolve without causing cervical cancer.
About HPV and Cervical Cancer
HPV is a group of viruses with more than 100 types, 14 of which have been categorized as high risk for the development of cervical cancer. While most women will be infected with HPV at some point in their lives, the majority of these infections are transient and resolve without any clinical symptoms or consequences. However, a small number of HPV infections progress and result in disease ranging from genital warts to cervical cancer. Since most HPV infections do not result in cancer, there is a need for a more specific test to identify women at greater risk of developing that disease.
The most common test used for cervical cancer screening in the United States is the Pap test. Since the mid-1950s, screening with the Pap test has dramatically reduced the number of deaths from cervical cancer. Even so, the American Cancer Society estimates that there were more than 11,000 new cases of invasive cervical cancer in 2007, as well as nearly 4,000 deaths from the disease.
Despite the success of Pap testing in reducing mortality from cervical cancer in the United States, it does have limitations. One such limitation is poor sensitivity of individual Pap smears, which means the test misses cancers or precancerous changes. As a result, regular and repeated Pap testing is required to effectively detect a high proportion of cervical cancers. Another limitation is that approximately 2 million of the 50 million Pap tests performed annually in the United States have equivocal results, which are known as ASC-US. These women are often subjected to additional invasive tests, including biopsies, most of which prove negative.
About Gen-Probe
Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective nucleic acid tests (NATs) that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe has approximately 25 years of NAT expertise, and received the 2004 National Medal of Technology, America's highest honor for technological innovation, for developing NAT assays for blood screening. Gen-Probe is headquartered in San Diego and employs approximately 1,000 people. For more information, go to http://www.gen-probe.com.
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