FDA Clears First Nucleic Acid Amplification Test to Detect Common Sexually Transmitted Infection Trichomonas Vaginalis

SAN DIEGO, April 20, 2011 /PRNewswire/ -- Gen-Probe Incorporated (NASDAQ: GPRO) announced today that the US Food and Drug Administration (FDA) has cleared for marketing its APTIMA® Trichomonas vaginalis assay on the fully automated TIGRIS® system.

The APTIMA assay is the first amplified nucleic acid test specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the United States.  The assay may be used to test clinician-collected endocervical or vaginal swabs, urine, and specimens collected in PreservCyt solution from symptomatic or asymptomatic women.

"We believe our APTIMA Trichomonas assay will improve detection of a potentially serious sexually transmitted infection that is common in women of all ages," said Carl Hull, Gen-Probe's president and chief executive officer.  "Our assay will provide a convenient tool for physicians and laboratories because it employs the same technology as our market-leading tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system."

Trichomonas is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women.  If left untreated, complications can include premature labor, low-birth-weight offspring, and premature membrane rupture in pregnancy.  The US Centers for Disease Control estimate that 7.4 million American men and women are infected with Trichomonas annually.

Screening for Trichomonas is limited today due in part to the shortfalls of current testing techniques.  Most testing currently is done via culture methods, which are slow and less sensitive than molecular tests, or "wet mount," which requires the microscopic examination of a sample shortly after it is collected and is even less sensitive than culture.

About Gen-Probe

Gen-Probe 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 28 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 1,400 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, customer adoption, and future sales 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.  These risks, uncertainties and assumptions include, but are not limited to: (i) the risk that the market for the sale of our new products, such as our APTIMA Trichomonas vaginalis assay, may not develop as expected; (ii) the risk that we may not be able to compete effectively; and (iii) the risk that future R&D studies will not be positive.  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.

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SOURCE Gen-Probe Incorporated

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