The FDA has granted expedited 510(k) clearance and CLIA moderate complexity categorization for Focus Diagnostics’ Simplexa HSV 1 and 2 direct molecular test for diagnosing encephalitis.
According to Focus, a division of Quest Diagnostics, this is the first molecular test cleared in the U.S. to detect and differentiate herpes simplex virus 1 and 2 in cerebrospinal fluid of patients suspected of having HSV central nervous system infection, including encephalitis. It runs on the company’s 3M Integrated Cycler testing platform.
The test uses real-time polymerase chain reaction technology, which can detect viral or bacterial DNA or RNA, as well as genetic material from other analytes, eliminating the need for costly and time-consuming nucleic acid extraction, the company said. Nucleic acid extraction can take up to 90 minutes, whereas the Simplexa test turns results around in just an hour.
In clinical studies, the test demonstrated 100 percent HSV 1 sensitivity and 98 percent HSV 2 sensitivity, Focus said.
The CLIA categorization allows the test to be performed in doctors’ offices, hospitals and health clinics, further reducing the time patients and their physicians must wait for results.
Simplexa HSV 1 and 2 was CE marked in November 2013. Focus also markets Simplexa tests for adenovirus, C. difficile, influenza, respiratory syncytial virus and Group A Strep. — Lena Freund
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