GSD receives FDA clearance for next-generation Lyme disease Line Immunoassay

Gold Standard Diagnostics (GSD) today announced FDA clearance of its next-generation Lyme disease Line Immunoassay which offers excellent specificity and sensitivity at any disease stage. The testing procedure is highly intuitive and has sharper results than the traditional "Western blot". GSD's IgM and IgG LIA's satisfy CDC recommendations for confirmation testing and offer many improvements including: simple procedure, intuitive results, easy handling, durability and a well-defined antigen application.

The LIA strips contain specific Lyme disease antigen proteins that serve as markers for general infection and for specific stages. Lyme disease phases include: 1) early, 2) disseminated (also known as neuroborreliosis), and 3) late stage. The IgM strip contains markers for early and disseminated Lyme disease (IgM antibodies are generally not present beyond the disseminated stage). The IgG LIA contains a multitude of proteins to diagnose the disease at a specific stage, and also a number of general markers that are present throughout the disease cycle.

GSD also offers the sensitive, polyvalent EIA screen that the CDC recommends as the first step in diagnosis of Lyme disease. The EIA is certified as "ThunderBolt-Ready" ensuring quick and easy automation on the ThunderBolt™ EIA Platform. Along with Lyme disease, over 200 other assays from 20 different manufacturers are also certified as "ThunderBolt-Ready".