The U.S. Food and Drug Administration (FDA) has cleared new indications for four tests from Zeus Scientific that are designed to streamline the processing of testing for and diagnosing Lyme disease.
The FDA noted that Lyme disease traditionally has been diagnosed using a two-tier process to detect the presence of antibodies in a patient's blood against Borrelia burgdorferi, the tick-borne bacteria that causes Lyme disease. In this approach, clinical diagnosis was confirmed using two different types of tests, enzyme immunoassay (EIA) and western blot.
The Zeus tests cleared on July 29 involve a modified approach that uses only EIA technology-based tests, according to the agency. Research data submitted by Zeus to support its regulatory applications show that the company's technology, referred to as Modified Two-Tier Testing (MTTT), is as accurate as current methods for detecting antibodies to assess exposure to B. burgdorferi.
The tests are as follows:
- Zeus enzyme-linked immunosorbent assay (ELISA) Borrelia VlsE1/pepC10 IgG/IgM test system
- Zeus ELISA B. burgdorferi IgG/IgM test system
- Zeus ELISA B. burgdorferi IgM test system
- Zeus ELISA B. burgdorferi IgG test system
The clearances represent a step forward in making it easier for clinical labs to perform Lyme testing, according to Dr. Tim Stenzel, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
"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," Stenzel said in a release from the FDA. "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."