FDA grants clearance to new Lyme disease test
The US Food and Drug Administration (FDA) has cleared its new Lyme disease test, announces Diagnostics company ID-Fish Technology. The name of the test is iDart™ Lyme IgG ImmunoBlot Kit.
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. Moreover, it is the only immunoblot that includes Osp A (P31) and Osp B (P34).
The inclusion of 31 antigens improves the sensitivity of the detection of Lyme-specific IgG antibodies, which in turn will improve the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.
"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."
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. IGeneX, Inc., a specialty testing lab located in Northern California, has a licensing agreement with ID-FISH Technology to use the Lyme IgG ImmunoBlot strips in its laboratory-developed Lyme ImmunoBlot IgG assay.
Key Features of the iDart Lyme IgG ImmunoBlot Kit
• Results interpretation is 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.
• Bands 31 and 34 are included, making this the only FDA-cleared Lyme serological test that includes these bands.
Lyme disease is one of the fastest-growing infectious diseases in the United States. Around 475,000 people are diagnosed with Lyme disease annually in the U.S. It is caused by Borrelia burgdorferi, a type of bacteria carried by deer ticks. Lyme disease symptoms include fever, headache, fatigue, chills, joint and muscle pain, and, in some instances, the presence of a rash.
ID-FISH Technology would like to thank the Bay Area Lyme Foundation, the Centers for Disease Control and Prevention, and IGeneX for providing the samples for the study. The FDA review team was also instrumental in its guidance and advice throughout the review process.
