Navigation Links
Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
Date:2/21/2008

SAN DIEGO, Feb. 21 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) has submitted to the U.S. Food and Drug Administration (FDA) a supplemental regulatory application for the additional use of the PROCLEIX(R) ULTRIO(R) assay to screen donated blood for the hepatitis B virus (HBV), the Company announced today. The FDA approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006.

The Company is seeking approval to use the assay to screen for HBV on both its semi-automated instrument platform and on the fully automated, high-throughput TIGRIS(R) system.

"Demonstrating that our PROCLEIX ULTRIO assay is able to identify HBV-infected blood donations that serological tests miss and submitting this supplemental Biologics License Application (BLA) to the FDA are major milestones for our blood screening business, and may further safeguard the U.S. donated blood supply," said Hank Nordhoff, Gen-Probe's chairman and chief executive officer.

Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics, Inc.

Background

In October of 2006, the FDA approved the PROCLEIX ULTRIO assay to screen donated blood, plasma, organs and tissue for HIV-1 and HCV on Gen-Probe's semi-automated instrument system. In May of 2007, the FDA granted a similar approval to use the assay on the TIGRIS system.

However, the PROCLEIX ULTRIO assay was not approved to screen donated blood for HBV, as the initial pivotal study for the assay was not designed to, and did not, demonstrate HBV yield. Yield is defined as HBV-infected blood donations that were intercepted by the PROCLEIX ULTRIO assay, but that were initially negative based on serology tests for HBV surface antigen and core antibodies. Based on discussions with the FDA, Gen-Probe and Chiron agreed to conduct a post-marketing study of the PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor-screening claim.

Gen-Probe began this post-marketing study in early 2007. To date, approximately 500,000 blood donations have been screened in the study, and two HBV yield cases have been identified. Data on these two yield cases comprise the foundation of the Company's supplemental BLA.

HBV is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. HBV infection can lead to liver failure, cirrhosis or cancer. According to the World Health Organization, more than 350 million people worldwide are chronically infected with HBV. More than one million people die annually as a result of HBV infections.

Trademarks

PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a trademark of Gen-Probe.

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 approximately 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 1,000 people. For more information, go to http://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 potential milestone payments 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, including the PROCLEIX ULTRIO assay, will not be cleared for marketing in the timeframes we expect, if at all, (ii) the risk that we may not earn or receive milestone payments from our collaborators, (iii) the possibility that the market for the sale of our new products, such as our PROCLEIX ULTRIO assay and PROCLEIX TIGRIS system, may not develop as expected, (iv) we may not be able to compete effectively, (v) we may not be able to maintain our current corporate collaborations and enter into new corporate collaborations or customer contracts, and (vi) we are dependent on Novartis and other 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.

Contact:

Michael Watts

Senior director, investor relations and

corporate communications

858-410-8673


'/>"/>
SOURCE Gen-Probe Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Gen-Probe Announces Webcast of Third Quarter 2007 Earnings Conference Call
2. Pharmion Submits European Marketing Authorization Application (MAA) for Vidaza(R) in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)
3. Takeda Submits New Drug Application for Alogliptin (SYR-322) in the U.S.
4. AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
5. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
6. Peregrine Pharmaceuticals Submits Clinical Protocol for New Phase II Trial of Bavituximab in Patients With Metastatic Breast Cancer
7. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
8. Peregrine Pharmaceuticals Submits Clinical Protocol to Initiate Bavituximab Phase II Trial in Patients With Metastatic Breast Cancer
9. BioMarin Partner AnGes MG, Inc. Submits BLA to Japanese Ministry of Health
10. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
11. EpiCept Provides Update on Clinical and Regulatory Progress with Ceplene(TM) and EpiCept(TM) NP-1 Cream
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... and SEOUL, South Korea , ... and Macrogen, Inc. today announced they will form ... procedures for precision medicine in cancer. The goal ... DEPArray™ digital-sorting technology with Macrogen,s high-throughput Next Generation ... under the Clinical Laboratory Improvement Amendments (CLIA) of ...
(Date:2/12/2016)... Feb. 12, 2016  Aralez Pharmaceuticals Inc. (Nasdaq: ... the Company will ring the Nasdaq Closing Bell at ... York at 4:00 p.m. ET on Tuesday, ... Adrian Adams , will perform the ... to 4:00 p.m. ET.  A live webcast will be ...
(Date:2/12/2016)... Carolina , 12 februari 2016 /PRNewswire/ ... (AAI/CML), een toonaangevende leverancier van productie en ... biotechnologische industrieën, kondigt vandaag een uitbreiding aan ... op haar locatie in Charleston, ... heeft geleid tot meerdere recente investeringen. ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... February 13, 2016 , ... The producers of Enterprises ... businesses. , The increasingly modern world of instantaneous consumption proves very convenient for ... sources such as oil and coal, which pollutes our air, water, and soil. It ...
(Date:2/13/2016)... ... February 13, 2016 , ... DDi , a ... Providers list for its expertise in eClinical Solutions. DDi has built its solution ... technology needs of global clients. DDi provides smarter technology for Clinical Development, Regulatory ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Lymphoma Research Foundation ... research and serving the lymphoma community through a comprehensive series of education programs, ... philanthropic community at its 10th anniversary Fashion Luncheon on Monday, February 8, 2016. ...
(Date:2/12/2016)... , ... February 12, 2016 , ... Coco Libre, the ... in Red Carpet Events LA GRAMMY’s Style Lounge Event. Coco Libre will offer musicians ... stay hydrated before the big event. The invitation-only gifting suite, held this year at ...
(Date:2/12/2016)... Las Vegas, NV (PRWEB) , ... February 12, 2016 , ... ... of North Las Vegas Mayor John J. Lee, Nevada Military Support Alliance president Scott ... newest Fisher House at the VA Southern Nevada Healthcare System. This will be ...
Breaking Medicine News(10 mins):