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Regulatory Focus™ > News Articles > 2019 > 7 > First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease

First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease

Posted 30 July 2019 | By Ana Mulero 

First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease

The US Food and Drug Administration (FDA) cleared expanded use indications on four Lyme disease test systems that may improve confidence in diagnosing people with the debilitating condition.
The Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm eliminates the need for a two-step process in laboratory testing of Lyme disease, reducing the turnaround time for obtaining and interpreting test results. Lyme disease diagnosis has historically involved a protein test called a Western Blot, which must be run after an initial enzyme immunoassay (EIA) test.
FDA Center for Devices and Radiological Health’s Office of In Vitro Diagnostics and Radiological Health Director Tim Stenzel said in a statement the clearance creates “a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test. These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients.”
The move marks a new testing paradigm for Lyme disease, addressing challenges such as accurate diagnosis, while the prevalence of the disease increases across the US. FDA issued guidance in March 2013 to address concerns with failures of tests in detecting Lyme disease.
Zeus Scientific received 510(k) clearance on its modified testing approach for use on its four EIA technology-based tests based on a review of data from clinical studies that demonstrated its accuracy to be equivalent to current methods for the detection of antibodies in assessing the exposure of Lyme disease's causative bacteria—Borrelia burgdorferi.
Zeus Scientific Chief Commercial Officer Chris Howard said that “nearly 30% of early Lyme disease cases” are “potentially missed by the current [standard two-tiered testing] algorithm due to the insensitivity of immunoblot tests.”
Zeus Borrelia MTTT runs the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system concurrently or sequentially with a second test system. The other tests cleared for this use are the Zeus ELISA Borrelia burgdorferi IgG/IgM test system, the Zeus ELISA Borrelia burgdorferi IgM test system and the Zeus ELISA Borrelia burgdorferi IgG test system.

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