Quest: FDA Clearance For Moderate Complexity Simplexa HSV Direct Molecular Test

(RTTNews) - Quest Diagnostics (DGX) said Monday its Focus Diagnostics products business has received expedited FDA 510(k) clearance and CLIA moderate complexity categorization for its new Simplexa HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler.

According to Quest, the test, which is now available for purchase in the U.S., is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal fluid (CSF) from patients suspected of HSV central nervous system (CNS) infection, including encephalitis.

The test uses a proprietary process that eliminates nucleic acid extraction, so clinicians can expect results within about an hour after providing a specimen for testing.

Encephalitis is an inflammation of the brain often caused by the herpes simplex or other viruses. HSV encephalitis occurs in all ages and during all seasons, with HSV-1 encephalitis more common in adults and HSV-2 encephalitis more common in newborn infants.