Hologic Obtains European CE Mark for Aptima® Assay to Detect Herpes Simplex Virus 1 & 2

 Hologic, Inc. announced today that it has obtained a CE Marking for the Company's Herpes Simplex Virus (HSV) assay, enabling the test to be marketed in the European Union. The Aptima® HSV 1 & 2 assay is a nucleic acid amplification test for the qualitative detection of HSV RNA in clinician-collected swab specimens from skin lesions.

The assay can be used to aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The assay distinguishes between HSV 1 and 2, which is recommended in all patients with first-episode genital herpes.Patients with HSV-2 are at increased risk for contracting and transmitting HIV-1 (human immunodeficiency virus).2