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Hologic Receives 510(k) Clearance for Herpes Simplex Virus Assay

NEW YORK (GenomeWeb) – Hologic said today that the US Food and Drug Administration has given it 510(k) clearance to market the Aptima Herpes Simplex Virus 1 & 2 molecular assay on its fully automated Panther system.

The assay, a nucleic acid amplification test used in conjunction with swab specimens from anogenital skin lesions, can be used to qualitatively detect and differentiate between HSV-1 and HSV-2. Clinicians collect samples using a new Aptima Multitest Swab Specimen Collection Kit or commercially available viral transport media.

Distinguishing between HSV 1 and 2 is recommended in all patients with first-episode genital herpes, Hologic said. Patients with HSV-2 are at increased risk for contracting and transmitting HIV-1, and pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies during birth, which can cause neurological complications.

The cleared assay aids in the diagnosis of HSV-1 or HSV-2 infections, or both, in symptomatic women and men, Hologic said.

Tom West, president of the Diagnostic Solutions Division at Hologic, said "Helping our clinical lab customers consolidate testing on the Panther system enables them to be more efficient and productive." He noted that the system enables the firm "to offer more people high-quality and faster testing results and improve detection of STIs, like herpes."

Many US-based laboratories today conduct HSV testing via live culture, which is both time-consuming and delivers results in days rather than hours, Holigic said, adding that studies show that HSV molecular diagnostic tests are three to five times more sensitive than live culture samples.

The firm added that its Panther system "substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time."

Tests run on the Panther system also include assays for other sexually transmitted infections and a virology menu.

The HSV 1 & 2 assay will be commercially available in the US, its territories, and Puerto Rico.