FDA clears Roche's automated type-specific herpes tests
Published on September 5, 2012 at 6:19 AM
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.