SAN DIEGO, March 31 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated announced today that the Company has begun a pivotal U.S. clinical trial of its investigational APTIMA(R) assay to detect human papillomavirus (HPV), which causes cervical cancer.
“Starting this highly complex, multi-center study was an important goal for Gen-Probe in early 2008,” said Carl Hull, the Company’s president and chief operating officer. “Enrolling our first patient last week is a testament to the hard work of our integrated product development team. We expect that their extensive efforts to date will ultimately result in the introduction of a highly accurate APTIMA HPV assay that improves the detection and treatment of cervical cancer.”
The investigational 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 that 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 many resolve without causing cervical cancer.
Women undergoing routine Pap testing at participating U.S. clinics are eligible to participate in the clinical study, which includes two arms. One arm enrolls women whose Pap results are classified as ASC-US (atypical squamous cells of undetermined significance), meaning they are neither normal nor clearly indicative of changes associated with progression to cervical cancer. In these cases, HPV testing can help determine appropriate medical management. The other arm enrolls women over age 30 whose Pap results are normal. This arm will assess the ability of the APTIMA HPV test to identify women who are at greater risk for cervical cancer.
Gen-Probe expects to enroll approximately 7,000 women in the study. Actual enrollment, however, may vary based on the prevalence of cervical disease among women in the trial. The trial enrollment and testing are expected to take approximately two years.
The APTIMA HPV assay is designed to run on Gen-Probe’s fully automated, high-throughput TIGRIS(R) instrument system, and on the Company’s current and future medium-throughput instrument platforms.
Separately, Gen-Probe remains on track to introduce its APTIMA HPV assay as a CE-marked product in Europe in the second half of 2008.
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.
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 this 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 possibility that the market for the sale of our APTIMA HPV assay may not develop as expected, (iv) we may not be able to compete effectively with other companies already selling HPV diagnostic products or which launch such products in the future, (v) we depend on a small number of contract manufacturers and single source suppliers of raw materials, (vi) changes in third-party reimbursement policies regarding our products could adversely affect their sales, (vii) changes in government regulation affecting our products could harm our sales and increase our development costs, and (viii) 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 of Gen-Probe, +1-858-410-8673
Web site: http://www.gen-probe.com/
