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Procleix in Medical News

Gen-Probe Reports Financial Results for Second Quarter 2009

...sed ordering patterns; lower U.S. shipments of the procleix ULTRIO assay due to the post-marketing study that ...prior year period; and lower U.S. shipments of the procleix HIV-1/HCV assay as customers prepared to adopt the procleix ULTRIO assay. Blood screening sales growth also w...

Gen-Probe Reports Financial Results for First Quarter 2009

..., PROGENSA and TIGRIS are trademarks of Gen-Probe Incorporated. ULTRIO and procleix are trademarks of Chiron, a business unit of Novartis Vaccines and Diagnost...hat the market for the sale of our new products, such as our TIGRIS system, procleix ULTRIO assay and PROGENSA PCA3 assay, may not develop as expected, (iv) the...

Gen-Probe Reports Strong Financial Results for Fourth Quarter and Full Year 2008

...y the US Food and Drug Administration (FDA) of the procleix ULTRIO assay on the TIGRIS system. Royalty ...programs such as the post-marketing studies of the procleix ULTRIO assay in the United States, the investigati...arter, as well as any incremental revenue from the procleix ULTRIO assay in the United States. For the full y...

Gen-Probe and Novartis Agree to Extend and Expand Blood Screening Collaboration

...rporate foreign exchange rate fluctuations approximately 10% higher or lower than recent levels, and do not yet include potential revenue from the new procleix ULTRIO assay in the United States. About Gen-Probe Gen-Probe Incorporated is a global leader in the development, manufacture and marketing...

Gen-Probe Reports Strong Financial Results for Third Quarter 2008, Raises Full-Year EPS Guidance

...y the US Food and Drug Administration (FDA) of the procleix ULTRIO assay on the TIGRIS system. For the first n...programs such as the post-marketing studies of the procleix ULTRIO assay in the United States, the investigati... $1.83 to $1.87 Recent Events -- FDA Approves procleix ULTRIO Assay. On August 13, Gen-Probe announced ...
Procleix in Medical Technology

Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay

...ughput TIGRIS(R) system. "Demonstrating that our procleix ULTRIO assay is able to identify HBV-infected bloo...kground In October of 2006, the FDA approved the procleix ULTRIO assay to screen donated blood, plasma, orga...use the assay on the TIGRIS system. However, the procleix ULTRIO assay was not approved to screen donated bl...

West Nile Virus Screening and Diagnostics Technology Emerges In Step with North American Outbreak

... utilizing two test manufacturers approved by the FDA under the investigational new drug mechanism (TaqScreen WNV test, Roche Molecular Systems, Inc.; procleix WNV assay, GenProbe, Inc.). Although screening has substantially reduced the risk of transfusion associated transmission, there have been screening f...
Procleix in Medical Products

PROCLEIX® West Nile Virus (WNV) Assay

Description:...e received a total of $3.47 million to date in contract funding from the National Heart, Lung, and Blood Institute, which has been used to develop the procleix WNV Assay. This assay was made available for use by U.S. blood centers under an Investigational New Drug Application (IND) on July 1, 2003, and curren...
Company:Gen-Probe

Procleix HIV-1/HCV Assay

Description:... Donor Screening: The procleix System has added a significant layer of a safety t...d Transcription-Mediated Amplification (TMA). The procleix HIV-1/HCV Assay can simultaneously detect the pres...ured by Gen-Probe and is marketed worldwide as the procleix System by Chiron Corporation. In 2002, Gen-Probe...
Company:Gen-Probe
Procleix in Biological Technology

FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay

...RIS(R) system. "Gaining full FDA approval of the procleix ULTRIO assay is an important milestone for our blo...ials to demonstrate the utility of the assay." The procleix ULTRIO assay is manufactured by Gen-Probe and sold...rtis business. Based on the full approval of the procleix ULTRIO assay on the TIGRIS system, Gen-Probe expec...

Gen-Probe Reports Strong Financial Results for First Quarter 2008, Raises Full-Year Guidance

...ited from continued international expansion of the procleix ULTRIO assay, from higher pricing associated with ...A Combo 2 assay and from commercial pricing of the procleix WNV assay on the TIGRIS system in the United State...%. Recent Events -- Regulatory Application for procleix ULTRIO Assay Submitted. On February 21, Gen-P...

Gen-Probe Reports Strong Financial Results for Fourth Quarter and Full Year 2007

...revenue associated with investigational use of the procleix WNV assay. Beginning in the third quarter of 2006,... customers, and the post-marketing studies for the procleix ULTRIO(R) assay in the United States. For the full...A Combo 2 assay, by commercial pricing of the procleix WNV assay on the TIGRIS system in the United ...

Gen-Probe Reports Strong Financial Results for Third Quarter 2007, Raises Full-Year Guidance for Earnings Per Share and Total Revenues

...revenue associated with investigational use of the procleix WNV assay. Beginning in the third quarter of 2006,...en who are not Gen-Probe employees. -- Update on procleix ULTRIO Post-Marketing Study. To date, partic... donations in the post-marketing study for the procleix ULTRIO assay, which is designed to demonstrat...
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