FDAnews Device Daily Bulletin

NuGenerex Gains CE Mark for Syphilis Test

Jan. 31, 2019

NuGenerex Diagnostics earned the CE Mark for its Express II syphilis treponemal assay, a rapid point-of-care diagnostic test for syphilis antibodies in primary and secondary syphilis.

The test, which has an accuracy rate equal to or higher than standard lab assays for antibodies with sensitivities and specificities over 99 percent, is based on NuGenerex Diagnostics’ Express II diagnostic platform.

Results become available within 30 minutes from a drop of blood taken by a fingerstick and the device’s simplicity allow its use in all clinical settings.

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