SAN DIEGO, Nov. 21 /PRNewswire-FirstCall/ -- 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.
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.
Caution Regarding Forward-Looking Statements
Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning new products, potential regulatory approvals, and customer adoption are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, uncertainties and assumptions that may cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by any forward-looking statement. Some of the risks, uncertainties and assumptions that could cause actual results to differ materially from estimates or projections contained in the forward-looking statements include but are not limited to: (i) the risk that our APTIMA HPV assay will perform poorly in its US clinical trial, (ii) the risk that the APTIMA HPV assay will not be cleared for marketing in the timeframe we expect, if at all, (iii) the chance that additional studies of our APTIMA HPV assay may not confirm the results discussed here, (iv) the possibility that the market for the sale of our APTIMA HPV assay may not develop as expected, (v) we may not be able to compete effectively with other companies already selling HPV diagnostic products or which launch such products in the future, (vi) we depend on a small number of contract manufacturers and single source suppliers of raw materials, (vii) changes in third-party reimbursement policies regarding our products could adversely affect their sales, (viii) changes in government regulation affecting our products could harm our sales and increase our development costs, and (ix) litigation involving the assertion of third party patent rights could be expensive and divert management's attention, and/or result in damages or injunctive relief. The foregoing describes some, but not all, of the factors that could affect our ability to achieve results described in any forward-looking statements. For additional information about risks and uncertainties we face and a discussion of our financial statements and footnotes, see documents we file with the SEC, including our most recent annual report on Form 10-K and all subsequent periodic reports. We assume no obligation and expressly disclaim any duty to update any forward-looking statement to reflect events or circumstances after the date of this news release or to reflect the occurrence of subsequent events.
Contact: Michael Watts Senior director, investor relations and corporate communications 858-410-8673
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