FDA clears Roche Diagnostics’ tests to diagnose herpes viruses

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Covidien FDA approvalRoche Diagnostics Corp. announced Tuesday that the company has received clearance from the Food and Drug Administration to market two automated tests for herpes simplex virus 1 and 2.

The tests are meant to be used to diagnose such infections in people who are sexually active and on expectant mothers. The clearance is specifically for the IgG Antibody to diagnose herpes simplex virus (HSV) types 1 and 2 assays for use on its cobas modular platforms that analyze the results.

“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, in a news release. “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.”

Genital herpes, more associated with HSV type 2, affects one out of six people in the U.S.

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Arundhati Parmar

By Arundhati Parmar

Arundhati Parmar is the Medical Devices Reporter at MedCity News. She has covered medical technology since 2008 and specialized in business journalism since 2001. Parmar has three degrees from three continents - a Bachelor of Arts in English from Jadavpur University, Kolkata, India; a Masters in English Literature from the University of Sydney, Australia and a Masters in Journalism from Northwestern University in Chicago. She has sworn never to enter a classroom again.
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