San Diego, CA /PRNewswire-FirstCall/ – Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has submitted a Premarket Approval Application (PMA) to the US Food and Drug Administration (FDA) for its APTIMA® HPV (human papillomavirus) assay, a new molecular test that detects high-risk HPV infections that are associated with cervical cancer and precancerous lesions.
“Developing and testing our APTIMA HPV assay was our largest and most complex R&D program for a new diagnostic test, so we are very pleased to have filed for regulatory approval ahead of our year-end goal,” said Carl Hull, Gen-Probe’s president and chief executive officer. “We believe our assay, if approved by the FDA, could contribute significantly to women’s health by reducing the number of ‘false positive’ HPV test results that lead to unnecessary and expensive medical procedures. From a business perspective, this regulatory submission represents the last of five we have completed in the United States this year. when approved, we expect these new products to start an important new sales growth cycle for the Company.”
Gen-Probe’s pivotal study, known as the CLEAR (CLinical Evaluation of APTIMA HPV RNA) trial, involved more than 13,000 women undergoing routine Pap testing at 19 U.S. clinics. The trial included two arms to validate clinical utility, consistent with consensus HPV testing guidelines recommended by leading U.S. medical organizations. One arm enrolled women whose Pap results were classified as atypical squamous cells of undetermined significance (ASC-US), meaning they were neither normal nor clearly indicative of changes associated with progression to cervical cancer. in these cases, HPV testing can help determine appropriate patient management. The other arm enrolled women over age 30 whose Pap results were normal. this arm assessed the ability of the APTIMA HPV test to identify women who were at greater risk for cervical cancer.
Gen-Probe is seeking regulatory approval to run the APTIMA HPV assay on the Company’s fully automated, high-throughput TIGRIS® instrument system. Approximately 200 TIGRIS systems are being used today by U.S. clinical laboratories to test for Chlamydia and gonorrhea, two common bacterial sexually transmitted diseases.
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 messenger RNA (mRNA) from two viral oncogenes, E6 and E7, which are more prevalent in the severe cervical lesions likely to progress to cervical cancer. Gen-Probe believes targeting E6/E7 mRNAs may more accurately identify women at higher risk of having, or developing, cervical cancer than competing assays that target HPV DNA.
Previous studies of the APTIMA HPV assay from outside the United States have been published in peer-reviewed journals including the International Journal of Cancer and the International Journal of Gynecological Cancer. These studies have shown that the APTIMA HPV assay is highly sensitive for the detection of cervical cancer and precancerous lesions, while generating fewer “false positive” results for cervical disease than DNA-based HPV tests.
The CLEAR trial is the first large study of the APTIMA HPV assay in a US patient population. Gen-Probe intends to present the results of the trial at a future medical meeting.
About HPV and Cervical Cancer HPV is a group of viruses with more than 100 types, 14 of which are high risk for the development of cervical cancer. Most women will be infected with HPV at some point, but the majority of these infections are transient and resolve without clinical symptoms or consequences. However, a small number of HPV infections persist and result in disease ranging from minor dysplasia to cervical cancer. since most HPV infections do not result in cancer, more specific tests are needed 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. Pap screening has dramatically reduced the number of deaths from cervical cancer. even so, the American Cancer Society estimates that there will be more than 12,000 new cases of invasive cervical cancer in 2010, and more than 4,000 deaths from the disease.
Despite the success of Pap testing in reducing cervical cancer mortality, it does have limitations. One such limitation is poor sensitivity for detecting cervical disease from 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 for cervical disease.
About Gen-Probe Gen-Probe Incorporated is a global leader in the development, manufacture and marketing of rapid, accurate and cost-effective molecular diagnostic products and services that are used primarily to diagnose human diseases, screen donated human blood, and ensure transplant compatibility. Gen-Probe has approximately 27 years of expertise in nucleic acid testing (NAT), 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 1,300 people. For more information, go to 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 the APTIMA HPV assay will not be approved for marketing in the timeframe we expect, or may never be approved; (ii) the chance that additional studies of our APTIMA HPV assay may not be favorable; (iii) the possibility that the market for the sale of our APTIMA HPV assay may not develop as expected; (iv) the risk that 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) the risks created by our dependence on a small number of contract instrument manufacturers and single source suppliers of raw materials; (vi) possible changes in third-party reimbursement policies regarding our products could adversely affect sales of these products; (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.
SOURCE Gen-Probe Incorporated
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