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

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
'/>"/>

SOURCE Gen-Probe Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:1/23/2015)... Jan. 23, 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) ... of Advaxis, Inc. ("Advaxis" or the "Company") (NASDAQ: ... its fiduciary duties to shareholders. On January ... website reporting that Advaxis had misrepresented the clinical data ...
(Date:1/23/2015)... SETAUKET, N.Y. , Jan. 23, 2015  Lixte Biotechnology Holdings, ... where its Phase I trial of Lixte,s lead compound, LB‑100, ... institutions. John S. Kovach , M.D., the ... was planned to be completed at a single site. Accrual ...
(Date:1/23/2015)... Jan. 23, 2015 Gem Pharmaceuticals announced today that ... enrolled into the Company,s Phase 2 clinical trial.  This ... Gem,s lead compound, GPX-150 (an investigational medication), in approximately ... disease. Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO ...
Breaking Medicine Technology:Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 2Lixte Biotechnology Holdings Announces Expansion Of Clinical Sites For Its Phase I Trial Of Its Lead Anti-Cancer Compound, LB-100 3Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2
(Date:1/22/2015)... January 22, 2015 Blue Cross and Blue ... who exemplify what it means to “Live Fearless.” ... people to share their stories about how they or someone ... inspired others by living in the moment. By telling these ...
(Date:1/22/2015)... New York (PRWEB) January 22, 2015 The ... ) in the U.S. District Court, Southern District of West ... Bard, Inc. in that proceeding’s first bellwether trial. In an ... for a new trial after finding that C.R. Bard had ...
(Date:1/22/2015)... (PRWEB) January 22, 2015 A new ... of experience and person-centeredness in the long-term care environment ... action across the continuum. The paper, “The Power of ... engages perspectives and practices of the patient, resident and ...
(Date:1/22/2015)... 2015 Autocarinsurancebest.com has released a new blog ... auto insurance policy . , Auto insurance quotes help ... is no longer necessary to call an agent or visit ... online on a single website: http://autocarinsurancebest.com/ . , Every ...
(Date:1/22/2015)... released a new blog post presenting the basic features of ... an accidental death and dismemberment rider for a car insurance ... benefits if the insured dies in an accident. Accidental death ... insurance. , AD&D is not expensive and can be ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Commercial Auto Insurance Provides Several Important Features! 2Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2
... Now Approved with Four Indications for Five-Day Regimen, ... Food and Drug,Administration (FDA) has approved use of ... I.V. and oral, for the treatment of,complicated urinary ... This latest approval is based on results of ...
... The way the government keeps our,medicines ... goes through.,Those changes were the subject of ... Listen to this report from Pfizer at:, ... video, audio, text, graphics and,photos for free ...
... BKD ) announced today that its Board of ... stock of $0.50 per share for the,quarter ending September ... October 12, 2007 to holders of record of Brookdale,s ... Inc. is a leading owner and operator of senior,living ...
... VANCOUVER, Sept. 17 /PRNewswire-FirstCall/ - Cardiome Pharma ... Chairman and Chief,Executive Officer, will present an overview ... in San Francisco at 8:00am Pacific Time,(11:00am Eastern ... live webcast of Mr. Rieder,s presentation can be ...
... Million People Nationwide to take 10 Billion, Steps and ... WASHINGTON, Sept. 17 More than 1,500 YMCAs nationwide,will ... living and,healthy eating during "America On the Move Week ... with the America On the Move,Foundation, aims to educate ...
... Company,s Executive Team, VIRGINIA BEACH, Va., Sept. ... announced that Mary McCluskey, MD, has been,named Chief ... 1.5 million members. "We are excited to ... AMERIGROUP President and Chief Executive Officer. "Throughout her,career, ...
Cached Medicine News:Health News:FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis 2Health News:FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis 3Health News:FDA Approves LEVAQUIN(R) Short-Course Therapy for Treatment of Complicated Urinary Tract Infections and Acute Pyelonephritis 4Health News:Cardiome to Present at ThinkEquity Conference 2Health News:Cardiome to Present at ThinkEquity Conference 3Health News:Activate America(R) Brings Together YMCAs Nationwide to Promote Small Steps Toward a Healthier Lifestyle During 'America on the Move Week With the YMCA,' September 22-29, 2007 2Health News:Activate America(R) Brings Together YMCAs Nationwide to Promote Small Steps Toward a Healthier Lifestyle During 'America on the Move Week With the YMCA,' September 22-29, 2007 3Health News:Activate America(R) Brings Together YMCAs Nationwide to Promote Small Steps Toward a Healthier Lifestyle During 'America on the Move Week With the YMCA,' September 22-29, 2007 4Health News:Activate America(R) Brings Together YMCAs Nationwide to Promote Small Steps Toward a Healthier Lifestyle During 'America on the Move Week With the YMCA,' September 22-29, 2007 5Health News:AMERIGROUP Names Mary McCluskey, MD, Chief Medical Officer 2Health News:AMERIGROUP Names Mary McCluskey, MD, Chief Medical Officer 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: