Healthcare Industry News:  gonorrhea 

Diagnostics FDA

 News Release - August 22, 2006

Gen-Probe Receives FDA Clearance to Test Additional Specimen Types for STDs With the APTIMA Combo 2(R) Assay on the TIGRIS(R) System

Approval Makes Testing More Convenient, Expands TIGRIS Menu

SAN DIEGO, Aug. 22 (HSMN NewsFeed) -- Gen-Probe (Nasdaq: GPRO ) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance to use the APTIMA Combo 2® assay to test two additional kinds of patient samples for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) on the fully automated TIGRIS® system.

The patient samples newly cleared to run on the TIGRIS system are liquid Pap specimens collected in the PreservCyt® solution and processed with Cytyc's ThinPrep® 2000 System, and clinician- and patient-collected vaginal swab specimens.

"This clearance adds to the comprehensive solution that Gen-Probe offers customers for sexually transmitted disease (STD) testing, and helps them maximize the value of the unique, fully automated TIGRIS system," said Steve Kondor, Gen-Probe's vice president of sales and marketing. "Intercepting STDs in conjunction with ThinPrep Pap Tests, or via non-invasive vaginal swabs, provides physicians two additional, convenient ways to prevent serious medical complications and avoid unnecessary healthcare costs."

The APTIMA Combo 2 assay is cleared to detect Chlamydia infections and gonorrhea from a wide variety of sample types. In addition to liquid-based ThinPrep Pap Tests and vaginal swabs, these sample types include endocervical and urethral swab specimens, and female and male urine specimens. All these sample types can now be analyzed on the TIGRIS instrument, as well as on the Company's semi-automated instruments.

Gen-Probe received FDA clearance to test ThinPrep specimens with the APTIMA Combo 2 assay on the Company's semi-automated instruments last year. In the United States, approximately 50 million women receive an annual Pap test for cervical cancer. However, the conventional Pap smear has limited sensitivity and suffers from a large proportion of inadequate specimens. The ThinPrep Pap test was developed to address these limitations, and is the most commonly used method for cervical cancer screening in the United States.

The APTIMA® vaginal swab specimen collection kit received FDA approval in early 2004 for use on Gen-Probe's semi-automated instruments. Either a health care professional or a patient in a health care setting may use the non-invasive kit, which many women and their physicians have found to be a convenient and comfortable way to obtain an accurate STD test result.

The TIGRIS system is the only fully automated, high-throughput testing instrument for molecular diagnostics. The system automates all phases of nucleic acid testing, including sample preparation, amplification, detection and reporting results. Using the TIGRIS system, one operator can test 500 samples with the APTIMA Combo 2 assay in approximately 8.5 hours, or 1,000 samples in approximately 13.5 hours. In addition, one operator can run two TIGRIS systems simultaneously.

Chlamydia infections and gonorrhea are the two most common bacterial STDs. According to the Centers for Disease Control and Prevention (CDC), nearly 3 million Chlamydia infections and almost 1 million gonorrhea infections occur annually in the United States. These infections are often asymptomatic in both men and women. If left untreated, they can lead to serious complications, including pelvic inflammatory disease and ectopic pregnancy in women, and infertility in both men and women. However, early diagnosis and treatment can be both medically and economically efficient. The CDC, for example, estimates that every dollar spent on Chlamydia screening saves $12 in future medical costs.

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 more than 20 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 900 people. For more information, go to 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 new products will not be cleared for marketing in the timeframes we expect, if at all, (ii) the possibility that the market for the sale of our new products, such as our APTIMA Combo 2 assay and TIGRIS system, may not develop as expected, (iii) we may not be able to compete effectively, (iv) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (v) we are dependent on third parties for the distribution of some of our products. 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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