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:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, ... post-acute health care, have expanded their existing home health joint venture through an ... has been operating a joint venture home health company with Asante, delivering clinically ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... 10, 2017   West Pharmaceutical Services, Inc. ... injectable drug administration, today shared the results of a ... improving the intradermal administration of polio vaccines. The study ... in May 2017 by Dr. Ondrej Mach , ... Health Organization (WHO), and recently published in the journal ...
(Date:10/5/2017)... , Oct. 5, 2017  In response to ... Oral and Maxillofacial Surgeons (AAOMS) released prescribing recommendations ... to be used as a first-line therapy to ... Recognizing the value ... White Paper "Opioid Prescribing: Acute and Postoperative Pain ...
(Date:10/4/2017)... WESTWOOD, Mass. , Oct. 4, 2017  According to the Centers ... by the end of October . PhysicianOne Urgent Care is helping communities ... Westchester, NY , by offering no-cost* flu shots through ... , as mandated by certain health insurance regulations. ... The best time to get a flu shot is by ...
Breaking Medicine Technology: