GOLD STANDARD DIAGNOSTICS LYME DISEASE LIA RECEIVES 510(K)

Enhance lyme disease confirmation testing with line immunossay technology

superior testing procedure and easy-to-read results compared to traditional “western blots”

June 27, 2012, Davis, CA – Gold Standard Diagnostics (GSD) today announced 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 indiagnosis of Lyme disease.

Lyme disease is caused by three species of Borrelia bacteria: Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii. Most cases in the United States are caused by the Borrelia burgdorferi strain. The vast majority of cases are concentrated in the Northeast and Midwest United States, with over 94% of 2010 cases occurring in just 12 states in those regions.

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