Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.
“Lyme disease can have a devastating impact on patients. 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. 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,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
Lyme disease is caused by the bacteria Borrelia burgdorferi and is transmitted to humans through the bite of infected ticks. Typical symptoms include fever, headache, fatigue and skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart and the nervous system. In 2017, the last year for which the Centers for Disease Control and Prevention (CDC) has published data, a total of 42,743 confirmed and probable cases of Lyme disease were reported to CDC, an increase of 17% from 2016.
Laboratory diagnosis of Lyme disease has traditionally used a two-tier process for detecting the presence of antibodies against Borrelia burgdorferi in a patient’s blood. Antibodies are proteins present in the blood when the body is responding to a specific infection. In the previous two-tier approach, different types of tests were used (EIA and Western blots) to confirm a clinical diagnosis. The tests cleared today involve a modified approach that uses only EIA technology-based tests.