Lyme IgM and IgG ImmunoBlots Receive FDA Clearance
Newly-cleared technology is a game changer for the diagnosis of an often debilitating disease.
MILPITAS, Calif., July 2, 2025 (Newswire.com) - 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.
Using both IgM and IgG tests allows for full diagnostic coverage of a disease. IgM antibodies are produced first and suggest a current or recent infection, while IgG antibodies appear a few weeks later, can persist for a long time, and point to active, chronic, or past infection.
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.
"We are delighted to have received FDA clearance for our Lyme kits," 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 tests possible for the detection of Lyme disease. We look forward to working with partners to get these tests to patients."
ID-FISH Technology plans to start shipping kits in late 2025. Its primary customer base will be laboratories looking to get into Lyme disease testing or those who would like to add the iDart Lyme ImmunoBlots 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 ImmunoBlot strips in their laboratory-developed Lyme ImmunoBlot IgM and IgG Assays.
Key features of the iDart Lyme IgM and IgG ImmunoBlot Kits
• 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 these the only FDA-cleared Lyme serological tests that include these bands.
Lyme disease is one of the fastest-growing infectious diseases. Around 476,000 people are diagnosed annually in the US. Symptoms include fever, headache, fatigue, chills, joint pain, and, in some instances, the presence of a rash.
ID-FISH Technology would like to thank the Bay Area Lyme Foundation, the CDC, and IGeneX for providing the samples for the study. The FDA review team was also instrumental in their guidance throughout the review process.
For more information on ID-FISH Technology and the iDart Lyme ImmunoBlot Kits, please visit https://idfishtechnology.com.
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Source: ID FISH Technology, Inc.
