The US Food and Drug Administration has cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. This could assist in expediting the diagnosis of the disease and help prevent it being left untreated, which can lead to serious complications.
The disease poses a risk to travellers visiting the UK, North America and temperate areas of Asia. It is transmitted to humans by infected ticks and causes a rash that expands outwards over a period of days. Other symptoms can include fever, headache, chills, fatigue, joint pains, muscle aches and swollen glands. Left untreated, the infection can spread to other areas of the body and affect the heart, nervous system and joints.
Dr Tim Stenzel, Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, commented on the tests: “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.”