NEW YORK — ID-FISH Technology, a developer of diagnostic tools for tick-borne disease, said Tuesday that it has received FDA clearance for its iDart Lyme IgG ImmunoBlot Kit.
The test is designed for the detection of immunoglobulin G against Borrelia burgdorferi, the tick-transmitted pathogen that causes Lyme disease. It includes 31 Lyme antigen bands for improved sensitivity and is the only Lyme disease immunoblot that includes the B. burgdorferi proteins Osp A and Osp B, according to the Milpitas, California-based company.
ID-FISH said it plans to begin shipping the kits in the fourth quarter and that its primary customer base will be clinical laboratories. Under an existing licensing agreement, infectious disease lab IGeneX can use ID-FISH's immunoblot strips in its own lab-developed Lyme IgG ImmunoBlot assay.