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.
The Aptima HSV 1 & 2 nucleic acid amplification test qualitatively detects and differentiates between HSV-1 and HSV-2 on the automated Panther system.
The firm launched the service in part because it recognized that consumers increasingly prefer to pay for their healthcare services out of pocket and without having to get physician referrals.
The US Preventive Services Task Force said that the potential harms resulting from screening for HSV outweigh the potential benefits.
The test is the fifth assay on the Solana platform to obtain clearance, and expands the firm's offerings in the women's health market.