Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses a two-tier approach in which a pair of enzyme immunoassays (EIA) are performed followed by a separate protein test called a Western blot to confirm a Lyme disease diagnosis. But on July 29, 2019, the FDA broke new ground by clearing for the first time ever tests that follow a different model relying only on EIA technology-based tests which can be run concurrently or sequentially. Developed by Branchburg, NJ-based Zeus Scientific, the products were all approved via the FDA 510(k) pathway, including:

• The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System;
• 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

In granting 510(k) clearance, the FDA relied on data from clinical studies demonstrating that the alternative modified two-tier test approach is just as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi. The FDA also reiterated in announcing the clearance that CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.