FDA approves Simplexa HSV 1&2 Direct test for Herpes Simplex - Focus Diagnostics

Focus Diagnostics 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, 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 from patients suspected of HSV central nervous system infection, including Encephalitis. Simplexa tests, designed for use on the 3M Integrated Cycler, employ real-time polymerase chain reaction (PCR) technology to detect DNA or RNA in viruses, bacteria, and other analytes. 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.

Approval is based on clinical studies which showed the test has 100% and 98% sensitivity for detection of HSV-1 and HSV-2 respectively. The test was CE marked for distribution to more than 30 countries in Europe in November 2013.