Navigation Links
New Roche Dual Target HIV-1 Test Approved for Use in European Union
Date:12/15/2008

PLEASANTON, Calif., Dec. 15 /PRNewswire/ -- Roche announced today that its innovative dual-target HIV-1 test has received CE Mark certification, allowing it to be sold for clinical use in the European Union. The COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) HIV-1 Test, v2.0 utilizes a unique design to simultaneously amplify and detect two separate regions of the HIV-1 genome. This approach provides reliable test results even when mutations are present. The test uses Roche's proprietary fully automated real-time PCR technology to quantify the amount of HIV-1 RNA in a patient's blood.

"HIV mutations are a serious problem. Because it is impossible to predict when these mutations will occur, we have designed this test to detect all HIV-1 (Group M and O) strains," said Daniel O'Day, President and CEO of Roche Molecular Diagnostics. "This innovative fully-automated solution will provide reliable results for laboratories and physicians to more confidently and efficiently treat HIV-1 patients undergoing therapy."

It is critical for viral load monitoring tests to be able to quantify very low and high levels of virus, an indicator of the need for more or less aggressive treatment. The test is highly sensitive and can detect the World Health Organization HIV-1 RNA Standard in EDTA plasma as low as 20 copies per milliliter of patient sample. The test can also accurately quantify the amount of HIV in a patient sample up to 10 million copies/mL representing a broader dynamic range than previous generation tests.

About the COBAS(R) AmpliPrep/COBAS(R) TaqMan(R) System

The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) HIV Test, v2.0 is the first dual-target test to be offered on the COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System. The test is designed for use on the fully automated, real-time PCR platform, providing sample-in/results-out capability. The COBAS(R) AmpliPrep / COBAS(R) TaqMan(R) System is flexible and customizable to meet the space and workflow needs of any laboratory. In 2005, Roche received CE Mark certification for the full viral load monitoring menu (HIV-1, HBV, and HCV) on the system.

About HIV-1

According to estimates by the World Health Organization (WHO) and UNAIDS, 33.2 million people were living with HIV at the end of 2007. That same year, some 2.5 million people became newly infected, and 2.1 million died of AIDS, including 330,000 children.

The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the human immune system, destroying or impairing their function. In the early stages of infection, the person has no symptoms. Within 10-15 years an HIV infection will develop into acquired immunodeficiency syndrome (AIDS); antiretroviral drugs can slow down this process even further.

HIV is transmitted through unprotected sexual intercourse (anal or vaginal), transfusion of contaminated blood, sharing of contaminated needles, and between a mother and her infant during pregnancy, childbirth and breastfeeding.

The ability of HIV to mutate itself in the presence of antiretroviral drugs can lead to treatment failure, increased direct and indirect health costs associated with the need to start more costly second-line treatment for patients, the spread of resistant strains of HIV and the need to develop new anti-HIV drugs.(1)

About Roche and the Roche Diagnostics Division

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at http://www.roche.com.

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

     For further information please contact:
     Jessica E. Brillant
     Molecular Diagnostics Communications
     925.730.8503

    (1) World Health Organization. http://www.who.int

'/>"/>
SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Improved Testing for Hepatitis B Virus From Roche
2. Roche Signs Definitive Agreement to Acquire Memory Pharmaceuticals
3. Roche Holds Sixth Annual Childrens Walk in Nutley
4. New Jersey Jury Awards $12.9 Million to Three Patients Whose Use of Roche Acne Medication Accutane Found to Cause Severe Bowel Illness
5. Rochester Medical Reports Record Fourth Quarter Sales and Record Annual Sales
6. Primary Insomnia Tied to Brain Neurochemical Imbalance
7. Study links primary insomnia to a neurochemical abnormality in young and middle-aged adults
8. Roche Receives FDA Approval for Hepatitis C Viral Load Test on Its Fully Automated Real-Time PCR Platform
9. Rochester Medical Announces Fourth Quarter 2008 Earnings Conference Call November 6, 2008
10. Genentech/Roche/Chugais Avastin Will Garner More Than 20 Percent of the Total Breast Cancer Drug Market in 2017
11. Balloon Manor Reappears in Rochester
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/17/2017)... ... August 17, 2017 , ... ... Group, a Florida-based oncology business advisor to oncology practices, announced today the results ... amount of attributable savings from resolving critical clinical issues that would have otherwise ...
(Date:8/16/2017)... ... August 16, 2017 , ... The next Patient Care Academy at Kalamazoo Valley ... who successfully complete the seven-week long Patient Care Academy are eligible to take the ... salary for a CNA in Kalamazoo is $24,428.* , As a CNA, one is ...
(Date:8/16/2017)... ... August 16, 2017 , ... An August 3rd article on Reuters covers ... of a report in JAMA (the Journal of the American Medical Association). The study found ... to achieve BMIs under 30, when compared to patients with lower BMIs. At present, weight ...
(Date:8/16/2017)... (PRWEB) , ... August 16, 2017 , ... Ten outstanding ... Union's Stars in the Classroom and will win a visit by a Houston Texans ... K-12 who are at least five years old can visit texanschecking.com/stars to nominate their ...
(Date:8/16/2017)... ... August 16, 2017 , ... Any Lab Test ... The company ranked #4429 on the newly released, 36th annual Inc. 5000 , ... unique look at the most successful companies within the American economy’s most dynamic segment ...
Breaking Medicine News(10 mins):
(Date:8/17/2017)... N.J. , Aug. 17, 2017 Bio-Ess Laboratories, LLC Chief ... increase antibody titer and present new data on Cell-Ess® Universal ... in Boston, MA August 21-25.  The Bioprocessing Summit ... today,s bioprocess challenges. ... and Optimizer ...
(Date:8/15/2017)... , Aug. 15, 2017  AOTI Inc. announced today that ... Therapy Inc., has recently opened a New York City Office in ... usage of its unique Topical Wound Oxygen (TWO 2 ) homecare ... the Accreditation Commission for Health Care (ACHC) under the company,s DMEPOS ... ...
(Date:8/8/2017)... Second-quarter 2017 revenues of $876 million ... continuing operations Second-quarter 2017 ... million Second-quarter 2017 Sterile ... Second-quarter 2017 adjusted diluted earnings ... to $0.93 Second-quarter 2017 ...
Breaking Medicine Technology: