The FDA expanded the marketing indications of a line of diagnostic tests to include checks for Lyme disease—the first cleared by the agency to use a new parallel testing method.
Developed by Zeus Scientific, the tests run two enzyme immunoassays either concurrently or sequentially instead of following the traditional two-step process to detect the disease, which includes a subsequent western blot procedure to detect target proteins and antibodies.
“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,” the FDA’s Tim Stenzel, director of the agency’s in vitro diagnostics office, said in a statement.
“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,” Stenzel said.
According to the latest published data from the Centers for Disease Control and Prevention (CDC), the incidence of Lyme disease has been on the rise. Over 42,700 cases were reported to the CDC in 2017, up 17% compared to the year before—mostly in the northeastern U.S. as well as in the states of Wisconsin and Minnesota.
“With nearly 30% of early Lyme disease cases being potentially missed by the current [standard two-tiered testing] algorithm due to the insensitivity of immunoblot tests, we are ecstatic to have successfully improved one of the most challenging aspects of diagnosis: detecting the disease early, before a robust immune response has been developed by some patients,” said Zeus’ Chief Commercial Officer Chris Howard, who described the new method as being able to detect up to 30% more cases.
The 510(k) clearances were granted to four Zeus Elisa systems that search for the specific antibodies linked to the bacterial infection that causes Lyme disease, forgoing the western blot test entirely and relying on enzyme immunoassays.
The fully automatable procedure developed by Zeus—which received the first FDA clearance for a Lyme disease screening test over 30 years ago—begins with its Elisa Borrelia VlsE1/pepC10 IgG/IgM test system, and is followed by an Elisa IgG, IgM or combination IgG/IgM test.