Automated HSV1 and 2 Test Receives US Marketing Approval

An automated real-time polymerase chain reaction (PCR) assay for the direct detection and differentiation of HSV1 (herpes simplex virus 1) and HSV2 (herpes simplex virus 2) DNA in anogenital specimens from symptomatic patients has been certified for diagnostic use in the United States.

The [US] Food and Drug Administration (FDA) has issued 510(k) clearance, which allows marketing as a diagnostic tool, for the Roche (Basel, Switzerland) cobas HSV1 and 2 Test for the early, simultaneous detection of HSV1 and HSV2 DNA in anogenital specimens.

The Roche HSV assay was developed for use on the cobas 4800 system. This system was designed to automatically perform real-time PCR for medium- to high-throughput laboratories (up to 384 samples a day). The system incorporates fully automated sample preparation from primary vials with ready-to-use, load-and-go reagents. No thawing or mixing is required and a full run of 94 samples can be set up in less than 20 minutes.

The cobas HSV1 and 2 Test joins the expanding US system menu that currently includes the cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, the cobas EGFR Mutation Test, and the cobas MRSA/SA Test.

"The addition of the cobas HSV 1 and 2 Test expands the menu for the cobas 4800 System, enabling labs to experience increased efficiency with innovative testing solutions," said Paul Brown, head of Roche Molecular Diagnostics. "This highly sensitive and specific new test for the detection of herpes simplex virus delivers reliable results to physicians for optimal patient treatment and clinical management decisions."

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