FDA Clears Gold Standard Diagnostics’ Borrelia burgdorferi IgG/IgM ELISA Assay

June 13, 2018 |

2 min read

The test is intended as an initial screening assay in the CDC recommended two-steps testing for evidence of antibodies against the Lyme disease bacteria

DAVIS, Calif.--(BUSINESS WIRE)-- Gold Standard Diagnostics, Corp. today announced the U.S. Food and Drug Administration issued a 510(k) clearance for its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC recommended two-steps testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same blood sample.

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CDC estimates approximately 329,000 Lyme disease cases are diagnosed per year (Photo: Business Wire)

GSD’s highly sensitive EIA Lyme screen contains B. burgdorferi strains B31 and 2591, as well as VIsE, an immunogenic lipoprotein included for optimal performance. This kit is easy to use, includes ready-to-use controls, and features a fast 15-15-15-minute incubation protocol, making it easy to automate.

“We are excited to be among the first companies to offer a complete Lyme testing solution that follows the CDC criteria and uses state-of-the-art technology,” said John Griffiths, President of Gold Standard Diagnostics. “Our advanced assays will help to improve the diagnosis of Lyme disease, which is often under- or misdiagnosed.”

According to the CDC, Lyme disease is the fastest growing vector-borne, infectious disease in the United States. (A vector-borne disease is one that is transmitted to people by blood-sucking insects and arachnids such as mosquitoes, fleas and ticks). Current CDC estimations of clinician-diagnosed Lyme disease is approximately 329,000 cases per year ¹. Lyme disease is most prevalent in the summer, with most cases concentrated on the East Coast and in the Midwest.

Alongside Gold Standard’s Lyme Immunoblot kits for Lyme confirmation testing, the newly available EIA kit provides GSD clients with a complete solution for Lyme testing.

1. https://wwwnc.cdc.gov/eid/article/21/9/15-0417_article (Accessed 6/11/2018)

ABOUT GOLD STANDARD DIAGNOSTICS, CORP.

Gold Standard Diagnostics, Corp. is a privately held clinical diagnostics company based in Davis, California. The company develops, manufactures and distributes a portfolio of instrumentation and diagnostic test kits to clinical laboratories in the U.S., EMEA, Asia, and South America. In addition to the AIX1000, current product offerings include the Thunderbolt^™ and Bolt^®, open format instrumentation platforms for enzyme and chemiluminescence immunoassays, and an extensive menu of serology tests across autoimmune, infectious, and endocrine diseases.