ZEUS Scientific Receives FDA Clearance to Market the AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System

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ZEUS Scientific announces it has received clearance from the U.S. Food and Drug Administration (FDA) to market the AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System. This new Test System is intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to Treponema pallidum specific antigen, in conjunction with non-treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection.

ZEUS Scientific announces it has received clearance from the U.S. Food and Drug Administration (FDA) to market the AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System. This new Test System is intended for the qualitative detection of specific human IgG class antibodies to Treponema pallidum in human sera. The presence of antibodies to Treponema pallidum specific antigen, in conjunction with non-treponemal laboratory tests and clinical findings, may aid in the diagnosis of syphilis infection. Both treponemal and non-treponemal tests are generally necessary to presumptively diagnose primary syphilis.

Syphilis is a bacterial infection that is usually sexually transmitted, but may also be passed from an infected mother to her unborn child. Syphilis is a curable sexually transmitted disease (STD) which, if left untreated, can eventually lead to irreversible damage to the heart and nervous system. Syphilis remains a global problem with an estimated 12 million people infected each year, despite the existence of effective prevention measures.

This is the industry leading 15th AtheNA Multi-Lyte® Test System cleared by the FDA, for in vitro diagnostic use. The AtheNA Multi-Lyte® System is a multiplexed bead-based system built on Luminex® xMAP® Technology. ZEUS Scientific Intra-Well Calibration Technology® provides a multi-point, patient-specific calibration curve for each sample in the same well, eliminating plate drift and ensuring result accuracy.

The AtheNA Multi-Lyte® Treponema pallidum IgG Plus Test System is available for sale through the ZEUS Scientific distribution network. Please visit http://www.zeusscientific.com to locate your local distributor.

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