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 test, which is now available for purchase in the United States, 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. 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. Simplexa HSV 1 & 2 Direct is intended to aid in the diagnosis of HSV central nervous system (CNS) infection using CSF from patients suspected of HSV infections of the CNS. Simplexa tests use a proprietary chemistry that eliminates the need for nucleic acid extraction, which involves purifying nucleic acids from a specimen.  Nucleic acid extraction is an expensive and time-consuming process requiring specialized equipment and trained personnel.

“The nucleic acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to the total time to result. Focus Diagnostics replaced the extraction process in our Simplexa products with a proprietary chemistry and technology,” said Michelle Tabb, Ph.D, Vice President, Research and Development for Focus Diagnostics. “Simplexa HSV 1 & 2 Direct results, like those of other Simplexa Direct test products, are available in about an hour from receiving a specimen for testing. This is a major advantage when dealing with an acute neurological condition like encephalitis.”

Simplexa HSV 1 & 2 Direct showed strong performance in clinical studies, with 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.