NEW YORK – DiaSorin Molecular has received US Food and Drug Administration clearance for its Simplexa VZV Swab Direct assay to detect varicella-zoster virus (VZV) DNA from cutaneous and mucocutaneous swab specimens, the firm announced on Tuesday.
The CLIA moderate complexity assay is designed for use on Diasorin's Liaison MDX instrument, which leverages real-time PCR technology. The firm said the test complements its Simplexa VZV Direct kit, which uses cerebrospinal fluid samples.
It is not always possible to visually distinguish VZV lesions from herpes simplex virus lesions because the clinical presentation can be similar. Therefore, it's critical for labs to identify VZV infection to enable proper patient treatment and management, DiaSorin said.
"With this release, we now offer a comprehensive menu of VZV and HSV tests from cerebrospinal fluid, mucocutaneous swab specimens, and cutaneous swab specimens," Michelle Tabb, chief scientific officer at DiaSorin Molecular, said in a statement. She said that customers can run all of the tests at the same time.
The company had obtained CE marking for its Simplexa VZV Swab Direct assay in September.