Navigation Links
Gen-Probe Begins U.S. Clinical Study of APTIMA(R) Trichomonas Vaginalis Assay on the TIGRIS(R) System
Date:8/17/2009

SAN DIEGO, Aug. 17 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its APTIMA((R)) assay for Trichomonas vaginalis on the fully automated TIGRIS((R)) system.

"Initiating a clinical trial of our APTIMA Trichomonas vaginalis assay is an important step forward in our efforts to help doctors and laboratories provide rapid, accurate detection of infectious diseases that can harm women's health," said Steve Kondor, Gen-Probe's senior vice president of sales and marketing. "Our Trichomonas assay will employ the same technology as our market-leading APTIMA assays for Chlamydia and gonorrhea, test the same samples, and run on our TIGRIS system, which remains the only fully automated, high-throughput testing system for molecular diagnostics."

Trichomonas is a sexually transmitted parasite that can cause vaginitis, urethritis, premature membrane rupture in pregnancy, and make women more susceptible to infection with HIV-1, the virus that causes AIDS. The U.S. Centers for Disease Control estimate that there are 8 million cases of Trichomonas infection annually in North America, making it even more prevalent than Chlamydia and gonorrhea, the most common bacterial sexually transmitted diseases.

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.

"A highly sensitive and specific trichomonas assay is a great way to leverage our large installed base of TIGRIS instruments, as well as the advantages we expect from our investigational PANTHER system down the road," said Eric Lai, Ph.D., Gen-Probe's senior vice president of R&D.

Gen-Probe's clinical study, which is expected to enroll approximately 800 women at about eight trial sites, is forecast to conclude in the first half of 2010. In the summer of next year, Gen-Probe intends to submit to the U.S. Food and Drug Administration a 510(k) application to enable laboratories to use its APTIMA assay to test for Trichomonas from multiple female specimen types.

As previously disclosed, Gen-Probe expects costs associated with clinical studies for the Company's Trichomonas, human papillomavirus (HPV) and PCA3 tests to contribute to research and development expenses of approximately $30 million in the third quarter of 2009.

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 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 1,200 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, customer adoption, and results of future R&D studies 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 clinical trial results for our trichomonas, HPV or PCA3 tests will not be favorable; (ii) the risk that new products, such as the assays mentioned above, will not be cleared for marketing in the timeframes we expect, if at all; (iii) the possibility that the market for the sale of our new products may not develop as expected; (iv) the risk that we may not be able to compete effectively; (v) the risk that we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts; and (vi) the risk that third parties may not distribute our products effectively. 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 Gen-Probe faces and a discussion of the Company's financial statements and footnotes, see documents filed with the SEC, including the 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.

    Contact:

    Herm Rosenman
    Senior vice president, finance and
    chief financial officer
    858-410-8900


'/>"/>
SOURCE Gen-Probe Incorporated
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Gen-Probe to Webcast Presentation at the Canaccord Adams 29th Annual Global Growth Conference
2. Gen-Probe Reports Financial Results for Second Quarter 2009
3. Gen-Probe to Webcast Two Upcoming Investor Presentations
4. Gen-Probe Reports Financial Results for First Quarter 2009
5. Gen-Probe, Roche Prevail in Arbitration With Digene Concerning Human Papillomavirus Agreement
6. Gen-Probe Board of Directors Elects Carl Hull Chief Executive Officer
7. Tepnel Shareholders Approve Acquisition by Gen-Probe
8. Gen-Probe Reports Strong Financial Results for Fourth Quarter and Full Year 2008
9. Gen-Probe to Acquire Tepnel Life Sciences, Fast-Growing European Molecular Diagnostics Company, for 92.8 Million Pounds Sterling ($132.2 Million) in Cash
10. Gen-Probe and Novartis Agree to Extend and Expand Blood Screening Collaboration
11. Eric Tardif Joins Gen-Probe as Senior Vice President, Corporate Strategy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , Belgium , June ... MKT: VNRX), today announced the appointment of Dr. ... of Directors as a Non-Executive Director, effective June ... Company,s Audit, Compensation and Nominations and Governance Committees.  ... Dr. Futcher will provide independent expertise and strategic ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
Breaking Medicine Technology: