Life Sciences Insight

Gold Standard Diagnostics Nabs FDA Clearance for Lyme Disease Test

Gold Standard Diagnostics (GSD) this week announced that the US Food and Drug Administration has granted clearance for the company’s B. burgdorferi IgG/IgM VlsE-OspC EIA test.

The test can now be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by the firm as part of a US Centers for Disease Control and Prevention-recommended modified two-tiered testing algorithm.

In 2014, the CDC issued an updated recommendation for the serologic diagnosis of Lyme disease, endorsing the use of a two-tier testing algorithm that uses a second enzyme immunoassay (EIA) in place of a Western immunoblot assay.

With the addition of the new test, GSD’s customers can choose which GSD tests and algorithms best meet Lyme disease testing needs, the firm said. “It is important to understand the need to combine assays designed to work in concert,” Barry Menefee, infectious disease specialist at GSD, said in a statement.

GSD, with US headquarters in Davis, California, is a member of Eurofins Technologies based in Budapest, Hungary.

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