ZEUS Scientific, Inc. Receives FDA Clearance To Market The AtheNA Multi-Lyte® Borrelia VlsE-1 IgG/pepC10 IgM Plus Test System.

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ZEUS Scientific announced it has received clearance from the U.S. Food and Drug Administration (FDA) to market the AtheNA Multi-Lyte® Borrelia VlsE-1 IgG/pepC10 IgM Plus Test System. This new Test System is intended for the qualitative detection of specific human IgG antibodies to VlsE-1 and IgM antibodies to pepC10 in serum samples from symptomatic patients or those with a history of Lyme Borreliosis. The AtheNA Multi-Lyte® Borrelia Test System utilizes a patented mathematical model which incorporates the two test results and combines them into a Bioinformatics Score, supporting the evidence of infection from B. burgdorferi.

ZEUS Scientific announced it has received clearance from the U.S. Food and Drug Administration (FDA) to market the AtheNA Multi-Lyte® Borrelia VlsE-1 IgG/pepC10 IgM Plus Test System. This new Test System is intended for the qualitative detection of specific human IgG antibodies to VlsE-1 (one of the repertoire of antigenic variants of VlsE from B. burgdorferi), and IgM antibodies to pepC10 (a 10 amino acid peptide found at the C-terminus of most OspC protein and associated with diagnosing acute Lyme disease and neuroborreliosis) in serum samples from symptomatic patients or those with a history of Lyme Borreliosis. The AtheNA Multi-Lyte® Borrelia Test System utilizes a patented mathematical model which incorporates the two test results and combines them into a Bioinformatics Score, supporting the evidence of infection from B. burgdorferi.

Greater than 25,000 cases per year of Lyme disease in the United States are now reported to the Centers for Disease Control and Prevention (CDC), making this one of the most common vector-borne diseases in the country.

This is the industry leading thirteenth 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. The Test System performs multiple assays simultaneously in the same well, from the same sample. 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® Borrelia VlsE-1 IgG/pepC10 IgM 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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