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FDA Clears Roche HSV 1 and 2 Test

NEW YORK (GenomeWeb) – Roche today announced that its cobas HSV 1 and 2 assay has received 510(k) clearance from the US Food and Drug Administration.

The dual target test detects and differentiates herpes simplex virus 1 and 2 DNA in symptomatic patients' anogenital specimens. 

Differentiating HSV-1 from HSV-2 can impact patient management and treatment, but herpes lesions can be confused with other conditions. Molecular testing is faster and is considered more sensitive than traditional viral culture. 

The PCR-based assay runs on the cobas 4800 system, which can report up to 94 results in less time that traditional methods and has a simplified workflow, enabling reduction of lab costs and improved turnaround time, the company said in a statement.

Cobas is now populated in the US with a menu of three tests for sexually transmitted infection, three for cancer-associated genetic markers, and three for healthcare-associated infection — including a Clostridium difficile assay which received FDA clearance last week. 

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