Gold Standard Diagnostics Announces FDA Clearance of the B. burgdorferi IgG/IgM VlsE-OspC EIA Test

Gold Standard Diagnostics Announces FDA Clearance of the B. burgdorferi IgG/IgM VlsE-OspC EIA Test




Gold Standard Diagnostics Announces FDA Clearance of the B. burgdorferi IgG/IgM VlsE-OspC EIA Test

DAVIS, Calif.–(BUSINESS WIRE)–Gold Standard Diagnostics (GSD), a Eurofins Technologies company, today announced FDA clearance of a new B. burgdorferi IgG/IgM VlsE-OspC EIA test. This test, when used in conjunction with the other FDA cleared GSD Lyme EIA tests can be used in the CDC recommended modified two-tiered testing (MTTT) 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, or EIA, in place of a western immunoblot assay.

Gold Standard Diagnostics now offers a solution for this Lyme testing algorithm, which complements GSD’s existing market-leading Lyme test portfolio. With the addition of the B. burgdorferi IgG/IgM VlsE-OspC EIA test, customers can choose which tests and algorithms best meet their laboratory and client’s needs. All six assays are designed for optimal performance and can be run on any open automation platform.

“With the addition of the B. burgdorferi IgG/IgM VlsE-OspC EIA test to the GSD Lyme product portfolio, GSD is the first and only single source company to offer Lyme testing solutions for both the Standard and Modified Two-Tiered Testing algorithms,” said Dr. Barry Menefee, infectious disease specialist at GSD. “It is important to understand the need to combine assays designed to work in concert. By offering the laboratory complete testing solutions, optimization is always met.”

ABOUT GOLD STANDARD DIAGNOSTICS, GROUP. Gold Standard Diagnostics, Group is a clinical diagnostics group comprised of Gold Standard Diagnostics Inc., VIROTECH Diagnostics GmbH, and NovaTec Immundiagnostica GmbH. The companies develop, manufacture and distribute a portfolio of instrumentation and diagnostic test kits to clinical laboratories around worldwide. The US GSD Inc. is headquartered in Davis, CA. Gold Standard Diagnostics is a member of the Eurofins Technologies group of companies.

References

  1. Molins CR, Sexton C, Young JW, et al. Collection and characterization of samples for establishment of a serum repository for Lyme disease diagnostic test development and evaluation.
  2. Center for Disease Control and Prevention, Morbidity and Mortality Report MMWR, Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease, Weekly / August 16, 2019 / 68(32);703.

Customers

GSD Lyme kits and other products email USSales@gsdx.us, or www.gsdx.us.

Contacts

Katherine Hays

KHays@gsdx.us
(530) 759-8000