Navigation Links
Roche receives FDA clearance for herpes simplex virus type 1 and 2 tests
Date:9/4/2012

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: www.roche.com or www.roche-diagnostics.us.

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

todd.siesky@roche.com


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... 2016  While Abbott,s announced purchase of St. ... repair and stent business, healthcare research firm Kalorama ... firmly into patient monitoring.  Kalorama said that patient ... areas, with double-digit growth expected the next 5 ... Remote Patient Monitoring . Abbott Laboratories agreed ...
(Date:4/28/2016)... 2016 Treato , the ... announced today that it has been named a Cool ... in Life Sciences, 2016, Stephen Davies , ... focuses on life-science- oriented analytics, algorithms and smart machine ... doctors, confirm medication ingestion, and analyze unstructured information.   ...
(Date:4/28/2016)... 2016  ValGenesis, Inc., the market leader ... today announced that a prominent world provider ... chronic kidney failure has selected ValGenesis Validation ... validation process. The global medical device manufacturer ... manage their validation processes electronically. Upon completion ...
Breaking Medicine Technology:
(Date:4/29/2016)... , ... April 29, 2016 , ... ... loans more flexibility in repaying their loans, more information about their loan terms ... when total outstanding student loan debt, including federal and private loans, has reached ...
(Date:4/29/2016)... Petersburg, Fla. (PRWEB) , ... April 29, 2016 ... ... Children’s Hospital surgeon reveals that infants born with severe congenital diaphragmatic hernia have ... babies is born with congenital diaphragmatic hernia (CDH)—a condition where the diaphragm fails ...
(Date:4/29/2016)... Kansas City, Missouri (PRWEB) , ... April 29, 2016 , ... ... Unlike traditional crutches which put pressure on the armpits, the M+D Crutch evenly distributes ... less strain on their wrists and hands when using the crutches than with other ...
(Date:4/29/2016)... ... ... the deadliest type of skin cancer. Although only about 1 percent of skin cancer cases ... 10,000 people are expected to die of melanoma this year. The risk increases with age, ... most commonly diagnosed cancers in young women. A recent breakthrough in genetic studies may give ...
(Date:4/29/2016)... Hills, CA (PRWEB) , ... April 29, 2016 , ... ... of devices and products for the head and neck/ear, nose and throat specialty, has ... Device , The KOTLER NASAL AIRWAY™ is a newly patented safety device ...
Breaking Medicine News(10 mins):