The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
The Simplexa VZV Swab Direct runs on the firm's Liason MDX instrument and has also been submitted to the US Food and Drug Administration.
The firm said that its HSV and varicella-zoster virus assay delivers answers for related herpes conditions in about an hour.
The company plans to take a tiered approach to assay development, targeting its first test to 10 viruses commonly detected in transplant patients.
Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.
The fully automated system has 12 independent thermal cyclers and runs the firm's diagnostic kits, but it can also operate as an open instrument.
With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.
The firm expects to build out a menu for the reader, which will automate results reporting for colorimetric- and fluorescence-based tests.
The Sentosa SA201 HSV-1/2 PCR test detects herpes virus DNA from oral or anal skin lesions in symptomatic patients.
The test is designed to detect and differentiate herpes simplex virus types 1 and 2, Treponema pallidum, and varicella-zoster virus.