Navigation Links
Roche announces FDA approval of HIV viral load test
Date:7/2/2012

PLEASANTON, Calif., July 2, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in  the US later this year. Like other innovative Roche HIV tests, this one targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing increased reliability as compared to other single target assays should a mutation occur.

"The approval of the Roche HIV test expands the availability to more laboratories, clinicians and patients," said Paul Brown, PhD, Head of Roche Molecular Diagnostics. "Roche is committed to developing new diagnostic tools such as this highly innovative HIV 'dual target' test to help improve the ability of physicians to monitor viral load and properly treat people living with HIV."

About this test

The COBAS® TaqMan® HIV-1 Test, v2.0  utilizes the FDA-approved High Pure System Viral Nucleic Acid Kit for manual specimen preparation and the COBAS® TaqMan® 48 Analyzer for automated amplification and detection.

About the dual-target test approach

Roche's dual-target approach for HIV viral load testing ensures enhanced reliability of results and increased confidence in assessing viral loads even in the face of the rapidly growing genetic diversity of HIV-1.[1],[2]   This approach targets two highly conserved regions of the HIV-1 genome and avoids any regions which are current drug targets, thus providing reliable test results even with rare mismatches in primer/probe binding sites and when mutations are present.  Since Roche first introduced this innovative dual-target approach for monitoring HIV-1 patients on antiretroviral therapy in 2008, over eight million tests have been performed worldwide on Roche fully automated real-time PCR platforms.

About HIV

According to the Centers for Disease Control and Prevention (CDC), an estimated 1.2 million persons were living with HIV infection in the United States at the end of 2010. Of those, 20% had undiagnosed HIV infections.[3]  Highly active antiretroviral treatment (HAART) and viral load tests that determine the amount of circulating HIV have contributed to a profound increase in life expectancy for people living with HIV.[4] 

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

[1] Clark SA, Calef C, Mellors JW. Mutations in retroviral genes associated with drug resistance. HIV sequence database. http://www.hiv.lanl.gov/content/sequence/HIV/REVIEWS/2006_7/RESISTANCE/Resist.html. Accessed August 29, 2008.

[2] Chequer-Fernandez SL, Rodrigues CA, Campos-Melo DL, Pilotto JH, Morgado MG. HIV-1 polymorphism: evaluation of its potential implication for the response to antiretroviral therapy of HIV-1 infected patients with prevalent subtypes in Rio de Janeiro, Brazil [abstract]. Presented at: 15th International AIDS Conference; July 11-16, 2004; Bangkok, Thailand. Abstract MoPeC3442. http://gateway.nlm.nih.gov/result_am?query=Chequer-Fernandez&id=102279743&itemnum=6&amhighlight=Yes&amsort=Relevance. Accessed August 19, 2008.

[3] Centers for Disease Control and Prevention. HIV Surveillance Report, 2010; vol. 22. http://www.cdc.gov/hiv/topics/surveillance/resources/reports/. Published March 2012. Accessed June 18, 2012.

[4] Lancet. Volume 372, Issue 9635, 26 July 2008-1 August 2008, Pages 293-299

For further information please contact Roche Molecular Systems at 888-545-2443


'/>"/>
SOURCE Roche Molecular Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Rochester Medical Introduces Magic3® Coude Tip Hydrophilic Intermittent Catheter
2. OncoSec ElectroChemotherapy Demonstrates Potential as Alternative to Surgery for Treating Head and Neck Cancer
3. Bronstein, Gewirtz & Grossman, LLC Announces Investigation of Amylin Pharmaceuticals, Inc.
4. K-V Pharmaceutical Company Announces Notification from NYSE Regarding Listing Criteria
5. Talyst Announces AutoSplit Contract Pharmacy at 340B Coalition
6. KALO Announces Distribution Areas
7. Lexicon Announces Publication of Results of Two Studies of LX4211 in Patients with Type 2 Diabetes in the Journal Clinical Pharmacology & Therapeutics
8. Medivir Announces an Interferon-Free Phase II Combination Trial With TMC435 and daclatasvir to Commence Shortly
9. Hanger, Inc. Announces Second Quarter 2012 Earnings Release Conference Call
10. ResMed Announces Conference Call And Webcast To Discuss Fourth Quarter And Fiscal Year-End 2012 Results
11. Marshall Edwards Announces Name Change to MEI Pharma ("MEIP")
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 2016 Australia Glaucoma Surgery Devices Market ... report, "Australia Glaucoma Surgery Devices Market Outlook to ... Glaucoma Surgery Devices market. The report provides value, ... and average prices (USD) within market segement - ... company shares and distribution shares data for each ...
(Date:12/8/2016)... 8, 2016 Global Interventional Radiology Market: ... global interventional radiology market analyzes the current and ... an elaborate executive summary, including a market snapshot ... sub-segments. The research is a combination of ... bulk of our research efforts along with information ...
(Date:12/8/2016)... 8, 2016  Diplomat Pharmacy, Inc. (NYSE: DPLO) has been recognized ... Top Workplaces National Standard. To learn more about ... ... Inc.) ... survey administered by WorkplaceDynamics, LLC, a research firm specializing in organizational ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... December 09, 2016 , ... The Pennsylvania Athletic Trainers’ ... during the summer of 2016. The program was made possible by a Pennsylvania ... Department of Health and Human Services Administration. The broadcast, Use Your Head: ...
(Date:12/8/2016)... ... December 08, 2016 , ... Russ DiGilio ... the first national #QuackGivesBack campaign which supported local breast cancer organizations during National ... Quack Gives Back initiative, and we’re very pleased with the participation ...
(Date:12/8/2016)... ... December 08, 2016 , ... CURE Media Group, the ... advocacy groups, has aligned with Upstage Lung Cancer in efforts to combat lung cancer, ... Michael J. Hennessy, Jr said, “CURE Media Group is honored to team up with ...
(Date:12/8/2016)... Fla (PRWEB) , ... December 08, 2016 , ... ... smarter modes of access for customers and employees that are both engaging and ... 7 with Service Smart Technology, the software company revealed today its plans to ...
(Date:12/8/2016)... ... December 08, 2016 , ... STAT courier is pleased to announce ... service for Texas, they are expanding their presence in Dallas. One of the most ... will bring new jobs to the Dallas and Forth Worth market. STAT takes pride ...
Breaking Medicine News(10 mins):