NEW YORK (360Dx) – Gold Standard Diagnostics said today that the US Food and Drug Administration has cleared the company's Borrelia burgdorferi IgG/IgM ELISA assay.

The test is intended for use as the initial screen in the two-step testing process recommended by the US Centers for Disease Control and Prevention for detecting antibodies against B. burgdorferi, a bacterial species that can cause Lyme disease. GSD said that both steps can be performed using the same blood sample.