Healthcare Industry News:  gonorrhea 

Diagnostics FDA

 News Release - October 18, 2006

Gen-Probe Receives FDA Clearance to Run Standalone APTIMA(R) Tests for Chlamydia and Gonorrhea on the TIGRIS(R) System

Five FDA Approvals or Clearances for Gen-Probe in Two Months

SAN DIEGO, Oct. 18 (HSMN NewsFeed) -- Gen-Probe (Nasdaq: GPRO ) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance to run the Company's standalone APTIMA® assays for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) on the high-throughput, fully automated TIGRIS® system.

The two amplified nucleic acid tests, which were previously approved to run on Gen-Probe's semi-automated instrument systems, detect the microorganisms that cause the most common bacterial sexually transmitted diseases (STDs) in the United States.

"With this clearance, customers can now run on the fully automated, high-throughput TIGRIS system all three APTIMA assays that were previously cleared for use on our semi-automated instruments, depending upon the needs of the patient and the market served," said Steve Kondor, Gen-Probe's vice president of sales and marketing. "We believe this clearance gives us the broadest menu of STD products in the industry. In addition, the five approvals or clearances we have received in the last two months illustrate our ability to commercialize innovative, high-value molecular diagnostic tests that help prevent serious medical complications and avoid unnecessary healthcare costs."

Gen-Probe's primary amplified STD test is the APTIMA Combo 2® assay, which simultaneously detects CT and GC and was cleared to run on the TIGRIS instrument in December of 2003. The APTIMA CT assay and the APTIMA GC assay received FDA marketing clearance to run on Gen-Probe's semi-automated instruments in December of 2004 and March of 2005, respectively. All three assays have been cleared to detect the target bacteria in a wide variety of sample types, including clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. Because all three tests use the same APTIMA technology, laboratories can provide a greater number of testing options without the added costs of using multiple platforms. The APTIMA franchise complements Gen-Probe's PACE® products, which continue to be the most widely used non-amplified nucleic acid tests for CT and GC.

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 in the United States. 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.

In addition to the two FDA clearances announced today, Gen-Probe received FDA clearance in August to test additional sample types for STDs with the APTIMA Combo 2 assay on the TIGRIS system. Earlier this month, Gen-Probe also announced separate FDA approvals for the PROCLEIX® ULTRIO® assay and the APTIMA HIV-1 RNA qualitative assay.

APTIMA, APTIMA Combo 2, PACE and TIGRIS are trademarks of Gen-Probe. PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics, Inc.

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, APTIMA CT and APTIMA GC assays 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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