FDA Greenlights Assays Using New Test Model for Lyme Disease Diagnosis

Lyme disease is on the increase. And so is the number of products cleared for detecting it. In fact, products for detecting tickborne diseases have been reaching the U.S. market at a dramatically stepped up pace in the past two years. In 2018, the Food and Drug Administration (FDA) approved two different donor screening tests to detect Babesia, a tickborne parasite responsible for the babesiosis infection. Meanwhile, researchers at Columbia University developed the first multiplex array for diagnosis of Lyme disease and other tickborne diseases. The most recent development is the FDA’s expansion of clearance for four previously cleared tests to cover new indications to aid in the diagnosis of Lyme disease. Here’s why these approvals are significant and different from anything the agency has cleared before. The Lyme Disease Challenge Lyme disease is caused by the bacteria Borrelia burgdorferi which 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 the joints, heart, and 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 […]