THE FUTURE OF LYME TESTING IS NOW
IGeneX’s Lyme IgM ImmunoBlot, currently offered as a laboratory-developed test (LDT), has been converted to a test kit which has received FDA clearance. This is in addition to the company’s IgG ImmunoBlot LDT, which was converted to an FDA-cleared kit in 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 and point to past infection or immunity.
The kits are manufactured by ID-FISH Technology, Inc. and are called 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 tests on the market. Moreover, they are the only immunoblots that detect antibodies to Osp A (P31) and Osp B (P34).
The inclusion of multiple antigens improves the sensitivity of the detection of Lyme-specific antibodies, which in turn will improve the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.
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 this the only FDA-cleared Lyme serological test that includes these bands.
FAQS
The FDA cleared kits are currently not available from any labs. ID-FISH hopes to start selling to laboratories in late 2025. However, the IGeneX IgM and IgG ImmunoBlots, which are the foundation of the FDA cleared kits, are available now. Specifically, they are tests #325 and #335 on this form.
iDart™ Lyme IgM ImmunoBlot Kit and iDart™ Lyme IgG ImmunoBlot Kit.
The kits are available to CLIA certified labs across the United States, as well as International labs with comparable certification. We are not able to sell kits directly to doctors or patients.
IgM antibodies are produced first and suggest a current or recent infection, while IgG antibodies appear a few weeks later and point to past infection or immunity. Testing for both leads to a more accurate diagnosis.
ID-FISH Technology is the manufacture of the FDA-cleared kits. For more than 15 years, ID-FISH Technology has been the leader in the development of diagnostic assays using their patented fluorescent in situ hybridization (FISH) and ImmunoBlot technologies. These technologies provide greater sensitivity for the detection of tick-borne diseases.
WHY IGENEX FOR TICK-BORNE DISEASE TESTING?
For over 30 years, IGeneX has been at the forefront of diagnostic testing for Lyme disease and other tick-borne diseases. The relentless focus and commitment of the in-house IGeneX research department has produced the industry’s most effective diagnostic tests for tick-borne diseases.
IGENEX IS FULLY CERTIFIED
IGeneX is certified by CLIA (Clinical Laboratory Improvements Amendments of 1988) to perform high-complexity tests on human samples in all 50 states. Many competing labs are not. IGeneX also holds licenses and permits for individual states that require separate state licensures for performing diagnostic tests on samples from their residents. Including New York. This demonstrates that IGeneX meets the quality of standards at state and federal levels.