NEW YORK ─ 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.