The Food and Drug Administration (FDA) has cleared for marketing the ZEUS Borrelia Modified Two-Tiered Testing (MTTT) algorithm to help in the diagnosis of Lyme disease.

The FDA approval allows for a new 2-test approach using only enzyme immunoassays (EIA) that will run concurrently or sequentially to help streamline the diagnosis of a patient. Currently, Lyme disease is diagnosed using an initial EIA test followed by a separate protein test called a Western Blot to detect the presence of antibodies against Borrelia burgdorferi, the causative agent of Lyme disease. 

The ZEUS Borrelia MTTT uses the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System as a first-tier test with positive or equivocal specimens subsequently tested using a second ZEUS ELISA Test System. This alternative approach was found to be as accurate as current methods for assessing exposure to Borrelia burgdorferi based on FDA reviewed data from clinical studies. 

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“Our ZEUS Borrelia MTTT algorithm detected up to 30% more acute Lyme disease cases relative to the [Standard Two-Tiered Testing algorithm], significantly reducing the number of missed clinically positive patient samples while maximizing lab efficiency with fully automatable immunoassays,” said Chris Howard, Chief Commercial Officer at ZEUS Scientific.

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