Navigation Links
Roche receives FDA clearance for herpes simplex virus type 1 and 2 tests

INDIANAPOLIS, Sept. 4, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IgG Antibody to herpes simplex virus (HSV) types 1 and 2 assays for use on cobas® modular platforms. The tests are intended for use with sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-1 and HSV-2 infection. 

"These are the first automated type-specific herpes tests available for integrated analyzer platforms, which will enable labs to integrate efficient herpes testing into their existing workflow," said Randy Pritchard, vice president of marketing at Roche Diagnostics Corporation. "The approval of the type-specific assays also means healthcare providers now have another tool to give them greater confidence in their diagnosis and overall patient care."

The addition of these tests further expands the company's infectious disease test portfolio for labs of all sizes. Roche currently offers the broadest test menu available on an integrated (chemistry and immunoassay) platform.

About the Tests
The Elecsys HSV-1 IgG and HSV-2 IgG assays are for the in-vitro qualitative determination of IgG class antibodies to HSV-1 and HSV-2 in human serum or plasma. The immunoassays are intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges. The tests are approved for use on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers.

About Herpes Simplex Virus
Herpes Simplex Virus Type 1 is mainly transmitted via social contacts during childhood and is generally prevalent in 70-90% of the population.  Herpes Simplex Virus Type 2 is usually transmitted sexually and has a prevalence of approximately 17-25% in the general population.  HSV Type 1 is most commonly associated with oral herpes, causing infections (sores) of the mouth and lips. HSV Type 2 is primarily associated with genital herpes. Type-specific HSV IgG detection is fundamental to helping healthcare providers manage patients and develop strategies to prevent transmission to partners and babies. 

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: or

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

For further information, please contact:

Todd Siesky

Director, Corporate Communications

Roche Diagnostics Corporation

Indianapolis, IN

(317) 521-3966

SOURCE Roche Diagnostics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Rochester Medical Reports Third Quarter Results
2. OncoSec OMS ElectroChemotherapy for Head and Neck Cancer Shows Enhanced Quality of Life in Two Randomized Phase III Studies
3. Rochester Medical Announces Third Quarter 2012 Earnings Conference Call Friday, July 27, 2012
4. FDA clears Accu-Chek Combo system - Roches new interactive insulin pump system for people with diabetes
5. Roche announces FDA approval of HIV viral load test
6. Rochester Medical Introduces Magic3® Coude Tip Hydrophilic Intermittent Catheter
7. OncoSec ElectroChemotherapy Demonstrates Potential as Alternative to Surgery for Treating Head and Neck Cancer
8. NxStage Patient and Advocate Brian Hess Receives Prestigious Honor from American Association of Kidney Patients
9. AcelRx Pharmaceuticals Receives Fourth and Fifth U.S. Patents for Small-Volume Oral Transmucosal Dosage Forms
10. China Botanic Receives New Patent on its Comprehensive Method to Enhance the Medicinal Value of Schisandra
11. Alder Biopharmaceuticals Receives $3.5 Million Milestone Payment from Bristol-Myers Squibb for Initiation of Phase 2 Clinical Trial of ALD518/BMS-945429 in Crohns Disease
Post Your Comments:
(Date:11/24/2015)... 24, 2015  Enova Illumination is pleased to announce ... Helsinki, Finland to combine their world class ... cutting edge of medical visualization: Enova is the first ... United States and Novocam is the manufacturer ... the world,s most powerful battery-operated LED headlight with high-quality ...
(Date:11/24/2015)... 24, 2015  BioPlast Manufacturing, a manufacturer of ... clinical diagnostic and biotech environments, announced today that ... quality petri dishes. This acquisition is aligned with ... of products that are designed and tested by ... quality.  Bristol, Pennsylvania ...
(Date:11/24/2015)... 2015  Eyewear brand Revo has debuted a ... singer and activist Bono as part of the " Buy ... blindness in more than 5 million people by 2020.  ... $10 from the sale of every pair of Revo sunglasses, ... of $10 million to the "Buy Vision, Give Sight" initiative. ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 24, 2015 , ... Brillouin Energy Corp. Congress and ... developer of renewable energy technologies capable of producing commercially useful amounts of thermal ... its WET™ and HHT™ Boiler System reactor core modules were presented to Congress ...
(Date:11/24/2015)... ... November 24, 2015 , ... American Family Care (AFC), the ... of a holiday pop-up clinic located in Metro Atlanta’s North Point Mall. The clinic ... and different way. The location is scheduled to operate through Dec. 24. , Holiday ...
(Date:11/24/2015)... ... November 24, 2015 , ... Abington Hospital – ... Institute of Quality® Bariatric Surgery Facility for treating individuals living with morbid or ... care services available to its members to help them make informed decisions about ...
(Date:11/24/2015)... ... 2015 , ... Bibliomotion is thrilled to announce the launch of ... Diversity by Nancy M. Schlichting, Chief Executive Officer of Henry Ford Health ... the needs of patients and their families, shaped my desire to improve the system ...
(Date:11/24/2015)... Nashville, Tennessee (PRWEB) , ... November 24, 2015 , ... ... 2015-2016 Pharmacy Quality Trend Report . Throughout the past year there have been multiple ... more mature state. During this transition, PharmMD has enabled their customers and partners to ...
Breaking Medicine News(10 mins):