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FDA Clears Focus Diagnostics HSV MDx

NEW YORK (GenomeWeb News) – Quest Diagnostics today announced that its Focus Diagnostics business has received expedited 510(k) clearance from the US Food and Drug Administration and CLIA moderate complexity categorization for its Simplexa HSV 1&2 Direct molecular test on the 3M Integrated Cycler.

Quest said the test is the first molecular assay cleared by FDA for the qualitative detection and characterization of herpes simplex virus 1 and HSV 2 in cerebrospinal fluid from patients who are suspected of having HSV central nervous system infection.

Using a proprietary chemistry, the test eliminates the need for nucleic acid extraction, reducing costs and the time to result to about an hour, Quest said.

Moderate complexity categorization of the test, Quest added, expands clinical access to the technology, as the categorization means certain laboratories, as defined by CLIA, can use the test. Such labs typically don't have the personnel and technology to perform high-complexity molecular diagnostic tests, and include those in physician offices, community hospitals, health clinics, and integrated delivery networks.

Simplexa tests are designed to run on the 3M Integrated Cycler, and use real-time PCR technology. Simplexa HSV 1&2 was CE marked in November 2013.