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 probable cases of Lyme disease were reported to the agency, an increase of 17% from 2016.

The Newly Cleared Tests

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. Testing follows a two-tier approach in which a pair of enzyme immunoassays (EIA) are performed followed by a separate protein test called a Western blot to confirm a clinical diagnosis of Lyme disease.

While the FDA has cleared laboratory tests for detecting Lyme disease before, the four clearances announced on July 29, 2019, break new ground because they are the first the agency has approved that follow a different model relying only on EIA technology-based tests which can be run concurrently or sequentially. The products which were approved via the FDA 510(k) pathway were all developed by Branchburg, NJ-based Zeus Scientific, including:

  • The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System;
  • The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System;
  • The ZEUS ELISA Borrelia burgdorferi IgM Test System; and
  • The ZEUS ELISA Borrelia burgdorferi IgG Test System

In granting 510(k) clearance, the FDA relied on data from clinical studies demonstrating that the alternative modified two-tier test approach is just as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi. The FDA also reiterated in announcing the clearance that CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.

Takeaway: “Clinicians have a new option to test for Lyme disease that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test,” noted 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. “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,” he added.


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