Gen-Probe's APTIMA HPV assay has been CE-marked for sale in the EuropeanUnion, and clinical trials of the test are underway in the United States. Theassay has not been approved for marketing by the U.S. Food and DrugAdministration.

"As a whole, these studies suggest that our new APTIMA HPV assay maydetect high-risk HPV infections that have progressed, or are progressing, tocervical cancer more specifically than competing assays that simply detectwhether HPV infection is present," said Dan Kacian, Ph.D., M.D., Gen-Probe'sexecutive vice president and chief scientist. "Since most HPV infectionsresolve without causing cancer, more specific tests are needed to avoidunnecessary and invasive medical procedures and patient anxiety. Additionallonger-term studies are needed and are underway, but these results give uscontinued confidence that our test may play an important role in helpingprotect women from both cervical cancer and the adverse effects of non-specific diagnosis."

In one key presentation at EUROGIN, Joseph Monsonego, M.D., EUROGINscientific director, presented interim results of the French APTIMA HPVScreening Evaluation (FASE) study from 1,528 women. The study eventually willinclude 5,000 women between the ages of 20 and 65. In the study, liquidcytology samples were tested with the Gen-Probe APTIMA HPV assay and withDigene/Qiagen's Hybrid Capture(R) 2 assay, and the results were compared tothe gold standard of histology (microscopic analysis of cervical tissue).

Dr. Monsonego concluded that in the study to date, the APTIMA HPV assayhad statistically identical sensitivity, but higher specificity, than theHybrid Capture 2 test. Other studies of the APTIMA HPV assay presented atEUROGIN showed similar results in geographically and clinically diversepatient groups. Additional details on these studies can be found in the"Science" section of the Gen-Probe website athttp://www.gen-probe.com/global/science.

About the APTIMA HPV Assay

The APTIMA HPV assay is an amplified nucleic acid test that detects 14high-risk HPV types that are associated with cervical cancer. Morespecifically, the assay detects two messenger RNAs (mRNAs), E6 and E7, thatare made in higher amounts when HPV infections progress toward cervicalcancer. Gen-Probe believes targeting these mRNAs may more accurately identifywomen at higher risk of having, or developing, cervical cancer than competingassays that target HPV DNA. Detecting HPV DNA identifies women who areinfected, but HPV infections are common and most resolve without causingcervical cancer.

About HPV and Cervical Cancer

HPV is a group of viruses with more than 100 types, 14 of which have beencategorized as high risk for the development of cervical cancer. While mostwomen will be infected with HPV at some point in their lives, the majority ofthese infections are transient and resolve without any clinical symptoms orconsequences. However, a small number of HPV infections progress and result indisease ranging from genital warts to cervical cancer. Since most HPVinfections do not result in cancer, there is a need for a more specific testto identify women at greater risk of developing that disease.

The most common test used for cervical cancer screening in the UnitedStates is the Pap test. Since the mid-1950s, screening with the Pap test hasdramatically reduced the number of deaths from cervical cancer. Even so, theAmerican Cancer Society estimates that there were more than 11,000 new casesof invasive cervical cancer in 2007, as well as nearly 4,000 deaths from thedisease.

Despite the success of Pap testing in reducing mortality from cervicalcancer in the United States, it does have limitations. One such limitation ispoor sensitivity of individual Pap smears, which means the test misses cancersor precancerous changes. As a result, regular and repeated Pap testing isrequired to effectively detect a high proportion of cervical cancers. Anotherlimitation is that approximately 2 million of the 50 million Pap testsperformed annually in the United States have equivocal results, which areknown 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, manufactureand marketing of rapid, accurate and cost-effective nucleic acid tests (NATs)that are used primarily to diagnose human diseases and screen donated humanblood. Gen-Probe has approximately 25 years of NAT expertise, and received the2004 National Medal of Technology, America's highest honor for technologicalinnovation, for developing NAT assays for blood screening. Gen-Probe isheadquartered in San Diego and employs approximately 1,000 people. For moreinformation, 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 arenot historical facts and are forward-looking statements. These statements areoften, but not always, made through the use of words or phrases such asbelieve, will, expect, anticipate, estimate, intend, plan and would. Forexample, statements concerning new products, potential regulatory approvals,and customer adoption are all forward-looking statements. Forward-lookingstatements are not guarantees of performance. They involve known and unknownrisks, uncertainties and assumptions that may cause actual results, levels ofactivity, performance or achievements to differ materially from thoseexpressed or implied by any forward-looking statement. Some of the risks,uncertainties and assumptions that could cause actual results to differmaterially from estimates or projections contained in the forward-lookingstatements include but are not limited to: (i) the risk that our APTIMA HPVassay will perform poorly in its US clinical trial, (ii) the risk that theAPTIMA 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 assaymay not confirm the results discussed here, (iv) the possibility that themarket 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 sellingHPV diagnostic products or which launch such products in the future, (vi) wedepend on a small number of contract manufacturers and single source suppliersof raw materials, (vii) changes in third-party reimbursement policiesregarding our products could adversely affect their sales, (viii) changes ingovernment regulation affecting our products could harm our sales and increaseour development costs, and (ix) litigation involving the assertion of thirdparty 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 resultsdescribed in any forward-looking statements. For additional information aboutrisks and uncertainties we face and a discussion of our financial statementsand footnotes, see documents we file with the SEC, including our most recentannual report on Form 10-K and all subsequent periodic reports. We assume noobligation and expressly disclaim any duty to update any forward-lookingstatement to reflect events or circumstances after the date of this newsrelease or to reflect the occurrence of subsequent events.

Contact: Michael Watts Senior director, investor relations and corporate communications 858-410-8673SOURCE Gen-Probe