NEW YORK – DiaSorin Molecular has received CE mark for an assay that detects DNA of varicella-zoster virus (VZV) directly from swab specimens, the firm announced today.
The test, called the Simplexa VZV Swab Direct assay, has also been submitted to the US Food and Drug Administration for 510(k) clearance, the firm said in a statement.
The Simplexa VZV Swab Direct assay enables direct detection of VZV DNA from both cutaneous and mucocutaneous swab specimens. It runs on DiaSorin's Liaison MDX instrument and complements its herpes simplex tests, such as the Simplexa HSV 1 & 2 Direct kit, the firm said.
"We are committed to expanding our menu of high-quality assays that can be used with our Liason MDX platform," said Michelle Tabb, DiaSorin Molecular's CSO.
"Customers are looking to consolidate the testing platforms in their labs. The workflow efficiencies we deliver and our rapidly growing test menu make our platform increasingly attractive and in demand," Tabb added.
The company has previously received CE mark for a test to detect and differentiate HSV-1, HSV-2, and VZV from cutaneous and mucocutaneous swab specimens, called the Simplexa HSV 1/2 & VZV Universal Direct MDx assay, as well as FDA clearance for a VZV test for cerebrospinal fluid samples and an expanded claim for its HSV testing to cover swab samples.