Healthcare Industry News:  HPV assay 


 News Release - May 28, 2008

Gen-Probe Launches in Europe CE-Marked APTIMA(R) HPV Assay for Detection of Human Papillomavirus

SAN DIEGO, May 28 (HSMN NewsFeed) -- Gen-Probe Incorporated (Nasdaq: GPRO ) announced today that the Company has launched in Europe its APTIMA® HPV assay, a highly specific molecular diagnostic test to detect high-risk strains of the human papillomavirus (HPV), which causes cervical cancer. The APTIMA HPV assay has been CE marked and is currently available for sale in 13 European Union countries.

"The CE marking and launch of our APTIMA HPV assay in Europe reflect Gen-Probe's commitment to the development of novel, more accurate molecular diagnostic tests to detect life-threatening infectious diseases such as cervical cancer," said Carl Hull, Gen-Probe's president and chief operating officer. "In addition, we are hopeful that, over time, our HPV test will become an important long-term financial growth driver on both our current and future automated instrument platforms."

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 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.

"By targeting two HPV genes that are associated with progression to cervical cancer, the APTIMA HPV assay may increase the specificity of cancer detection," said Jack Cuzick, professor of epidemiology at the Cancer Research UK Centre for Epidemiology, Mathematics and Statistics in London. Prof. Cuzick is leading the 953-woman "Predictors" study, a head-to-head comparison of various HPV assays. "Increased specificity -- meaning fewer false positive results -- is important so women are not subjected to the anxiety and expense of unnecessary medical procedures," he said. Data from the Predictors study were presented by Prof. Cuzick and other independent European researchers at the 24th International Papillomavirus Conference and Clinical Workshop in November of 2007.

The APTIMA HPV assay is designed to run on Gen-Probe's fully automated, high throughput TIGRIS® instrument system and on the Company's semi-automated DTS® instrument platform, and is expected to run on the Company's future, fully automated instrument for low- to mid-volume laboratories.

The APTIMA HPV assay is being manufactured by Gen-Probe's subsidiary, Molecular Light Technology, in Cardiff, Wales.

The APTIMA HPV assay is in clinical studies in the United States, and is not approved for marketing by the U.S. Food and Drug Administration.

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 the disease.

The most common test used for cervical cancer screening is the Pap test. Although the Pap test has helped reduce mortality from cervical cancer in many countries, 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 a small portion of women have equivocal Pap 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, APTIMA, DTS and TIGRIS are trademarks of Gen-Probe Incorporated.

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

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, product performance, 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. 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 US 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.

Source: Gen-Probe

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