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FDA Clears Zeus Scientific Lyme Disease Assays

NEW YORK – The US Food and Drug Administration today said it has cleared four enzyme immunoassay tests with new indications to diagnose Lyme disease.

The clearance marks the first time that the tests have been indicated to follow a new paradigm in which two enzyme immunoassay (EIA) tests can be conducted concurrently or sequentially, rather than running a Western Blot protein test after an initial EIA test, the agency said.

The tests receiving clearance under the FDA's 510(k) regulatory pathway were developed by Branchburg, NJ-based Zeus Scientific. They are the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM, Zeus ELISA Borrelia burgdorferi IgG/IgM, Zeus ELISA Borrelia burgdorferi IgM, and the Zeus ELISA Borrelia burgdorferi IgG.

"With today's action, clinicians have 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," Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a statement. "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 new approach — called a modified two-tier test — is as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi, the causative agent of Lyme disease, the FDA said.

Lyme disease is transmitted to humans through infected tick bites, and if left untreated, infection can spread to the joints, heart, and nervous system.