FDA Clears the Lyme ImmunoBlot by ID-FISH Technology

ID-FISH Technology, Inc., a leading provider of diagnostic tools for the detection of tick-borne diseases, has received FDA clearance for its Lyme ImmunoBlot test. The name of the test is iDart Lyme IgG ImmunoBlot Kit.
 
“We are delighted to have received FDA clearance for our Lyme ImmunoBlot Kit,” said Dr. Jyotsna Shah, Ph.D., Chief Scientific Officer of ID-FISH Technology. “The R&D team at ID-FISH has worked tirelessly on making sure that we deliver the most accurate test possible for the detection of Lyme disease. We look forward to working with partners to get these tests to patients who need a correct diagnosis.”
 
The iDart Lyme IgG ImmunoBlot Kit is a stand-alone test for the detection of IgG antibodies against Borrelia-causing Lyme disease. The iDart ImmunoBlot Kit features 31 Lyme antigen bands, which are more antigen bands than any other Lyme immunoblot test on the market. It is also the only immunoblot that includes Osp A (P31) and Osp B (P34).
 
By including 31 antigens, the Lyme ImmunoBlot test improves the sensitivity of the detection of Lyme-specific IgG antibodies.
 
The iDart Lyme IgG ImmunoBlot Kit provides results based upon new criteria and not CDC criteria. The bands are grouped according to their antigen groups. The test is considered positive if the Lyme Screen Antigen (LSA) band and one or more bands from at least two other groups are present on the ImmunoBlot. Also, in the test bands 31 and 34 are included, making this the only FDA-cleared Lyme serological test that includes these bands.
 
ID-FISH Technology plans to start shipping kits in the fourth quarter. Its primary customer base will be laboratories looking to get into Lyme disease testing or those who would like to add the iDart ImmunoBlot technology to their test menu.
 
A specialty testing lab located in Northern California, IGeneX, Inc., has a licensing agreement with ID-FISH Technology to use the Lyme IgG ImmunoBlot strips in its laboratory-developed Lyme ImmunoBlot IgG assay.