Mij
Senior Member (Voting Rights)
Newly-cleared technology is a game changer for the diagnosis of an often debilitating disease.
MILPITAS, CALIFORNIA / ACCESS Newswire / July 2, 2025 / ID-FISH Technology, Inc., a leading provider of diagnostic tools for the detection of tick-borne diseases, today announced that its Lyme IgM ImmunoBlot test kit has received FDA clearance. This is in addition to the company's IgG ImmunoBlot test kit, which received FDA clearance in August 2024.
The names of the test kits are iDart™ Lyme IgM ImmunoBlot Kit and iDart™ Lyme IgG ImmunoBlot Kit. The kits feature 26 and 31 Lyme antigen bands, respectively, which are more antigen bands than any other Lyme immunoblot test on the market. Moreover, they are the only immunoblots that can detect antibodies to Osp A (P31) and Osp B (P34) antigens.
The inclusion of multiple antigens improves the sensitivity of the detection of Lyme-specific antibodies, which in turn improves the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.
MILPITAS, CALIFORNIA / ACCESS Newswire / July 2, 2025 / ID-FISH Technology, Inc., a leading provider of diagnostic tools for the detection of tick-borne diseases, today announced that its Lyme IgM ImmunoBlot test kit has received FDA clearance. This is in addition to the company's IgG ImmunoBlot test kit, which received FDA clearance in August 2024.
The names of the test kits are iDart™ Lyme IgM ImmunoBlot Kit and iDart™ Lyme IgG ImmunoBlot Kit. The kits feature 26 and 31 Lyme antigen bands, respectively, which are more antigen bands than any other Lyme immunoblot test on the market. Moreover, they are the only immunoblots that can detect antibodies to Osp A (P31) and Osp B (P34) antigens.
The inclusion of multiple antigens improves the sensitivity of the detection of Lyme-specific antibodies, which in turn improves the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.