Hologic Inc, Marlborough, Mass, has obtained FDA clearance to market its Aptima herpes simplex virus (HSV) 1 and 2 molecular assay on the fully automated Panther system. The test will be commercially available in the United States, US territories, and Puerto Rico.

According to the US Centers for Disease Control and Prevention, more than 24 million Americans are infected with HSV-2, the herpes strain with more serious health implications.1

The Aptima HSV 1 and 2 assay is performed on clinician-collected swab specimens from anogenital skin lesions, and can be used to detect and differentiate HSV-1 and HSV-2 qualitatively.

Tom West, Hologic.

Tom West, Hologic.

“Helping our clinical lab customers consolidate testing on the Panther system enables them to be more efficient and productive,” says Tom West, president of the diagnostic solutions division of Hologic. “By partnering with our customers, we’ll be better able to offer more people high-quality and faster testing results, and improve detection of sexually transmitted infections like herpes. This new product clearance reflects our commitment to providing healthcare professionals and patients with greater certainty and peace of mind.”

The assay can be used to aid in the diagnosis of HSV-1 or HSV-2 infections in symptomatic women and men. It distinguishes between HSV-1 and HSV-2, which is recommended in all patients with first-episode genital herpes.2 Patients with HSV-2 are at increased risk for contracting and transmitting HIV-1 (human immunodeficiency virus).3 Pregnant women infected with HSV-2 are at risk of transmitting the virus to their babies during birth, which can cause neurological complications for the child.

The HSV assay joins a growing list of molecular tests available on Hologic’s Panther system. The Panther system substantially reduces hands-on time for laboratories by providing random and continuous access with rapid turnaround time. Studies show that molecular diagnostic tests for HSV are 3x to 5x more sensitive than live culture samples.2

For more information, visit Hologic.


  1. Incidence, prevalence, and cost of sexually transmitted infections in the United States [online]. Atlanta: Centers for Disease Control and Prevention, 2013. Available at: www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf. Accessed June 23, 2017.
  1. Patel R, Alderson S, Geretti A, et al. 2010 European guideline for the management of genital herpes [online]. London: International Union against Sexually Transmitted Infections, 2010. Available at: www.iusti.org/regions/europe/pdf/2010/euro_guideline_2010_herpes.pdf. Accessed June 23, 2017.
  1. Freeman EE, Weiss HA, Glynn JR, et al. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS. 2006;20(1):73–83; doi: 10.1097/01.aids.0000198081.09337.a7.