Newly-cleared test is a game changer for the diagnosis of an often debilitating disease.
MILPITAS, Calif., September 4, 2024 – ID-FISH Technology, Inc., a leading provider of diagnostic tools for the detection of tick-borne diseases, today announced that its Lyme ImmunoBlot test has received FDA clearance. 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, PhD., 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 been using the ID-FISH Lyme IgG ImmunoBlot strips in their Laboratory-Developed Lyme ImmunoBlot IgG Assay since 2017.
Key features of the iDart Lyme IgG ImmunoBlot Kit
- A standalone test with the following band reading criteria: LSA band plus one or more bands from at least two of the following groups: P93, P41, P39, P23, P31 and P34. It’s not the CDC criteria of ELISA + 5/10 Bands.
- Only kit that includes 31kDa (OspA) and 34kDa (Osp B) recombinant proteins.
- Includes additional recombinant protein variants in each group.
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 US. 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 their guidance and advice throughout the review process.
For more information on ID-FISH Technology and the iDart Lyme IgG ImmunoBlot Kit, please visit https://idfishtechnology.com.
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About ID-FISH Technology, Inc.
Since 2004, ID-FISH Technology, Inc. has been a leader in the development of diagnostic assays for the detection of infectious diseases in clinical samples. ID-FISH has pioneered a number of assays for the detection of Malaria, Lyme disease, and Tick-Borne Relapsing Fever. ID-FISH has also been awarded numerous grants from the Small Business Innovation Research project. These grants have enabled the company to patent its technology and develop FDA-approved test kits.
