Roche (RHHBY) Receives FDA Clearance for Herpes Simplex Virus Type 1 and 2 Tests
9/5/2012 7:13:54 AM
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 MODULARANALYTICS 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.
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.
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Director, Corporate Communications
Roche Diagnostics Corporation
SOURCE Roche Diagnostics