Seegene wins FDA emergency authorization for skin ulcer test

Seegene said Tuesday that its US subsidiary has received emergency use authorization from the US Food and Drug Administration for a molecular diagnostic test that can simultaneously detect four viruses associated with similar skin and mucosal lesions.

The Allplex HSV-1&2/VZV/MPXV Assay is a syndromic real-time polymerase chain reaction test developed by Seegene USA.

It detects herpes simplex virus types 1 and 2, varicella-zoster virus and the virus that causes mpox in a single test.

The company ...