New Lyme Disease Test Gets FDA Clearance
|
Time to read 3 min
Summary of New Lyme Disease Test Gets FDA Clearance
AcuDart Health would like to congratulate our laboratory provider, IGeneX, for having two of their laboratory developed Lyme disease tests turned into FDA cleared test kits. The IgG kit received FDA clearance in August 2024, and the IgM kit in June 2025. Having both IgM and IgG kits allows for full diagnostic coverage of the disease.
What are the key differences of these FDA cleared Lyme Disease Test 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.
What does FDA Clearance mean?
FDA clearance signifies that the U.S. Food and Drug Administration has authorized a medical device for marketing based on its substantial equivalence to a legally marketed device already on the market. This means the manufacturer has demonstrated, through the 510(k) process, that the new device is as safe and effective as the predicate device. It's a crucial step for many medical devices, but it doesn't necessarily mean the FDA has given the device its full "approval" as it does for more high-risk devices.
Will insurance cover FDA cleared Lyme Disease Tests?
There's no rule that just because a test is FDA cleared that insurance has to cover it. But if big labs start adopting it, especially hospital labs where everything's under contract with insurance companies, they're going to be pressured to actually start to cover them.
Who manufactures the FDA cleared Lyme kits?
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.
What is the process for getting FDA clearance for a Lyme disease test?
Getting FDA clearance for a medical device or product involves navigating a structured regulatory process to ensure safety and effectiveness. The process depends on the type of product (e.g., medical device, drug, or diagnostic) and its classification. 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.
How many Lyme disease tests have received FDA clearance?
As of 2025, there are less than 10 FDA-cleared Lyme disease tests , including both traditional and newer methods designed to improve diagnostic accuracy.
ZEUS ELISA Test Systems (Cleared July 2019) - The following four tests support the modified two-tier testing (MTTT) approach, which replaces the older Western blot method. These tests use enzyme immunoassays (EIA) run concurrently or sequentially, streamlining diagnosis and improving lab interpretation.
Borrelia VlsE1/pepC10 IgG/IgM
Borrelia burgdorferi IgG/IgM
Borrelia burgdorferi IgM
Borrelia burgdorferi IgG
These following two kits feature 31 antigen bands (IgG) and 26 bands (IgM), including highly specific proteins like OspA and OspB, which were excluded from older tests due to vaccine concerns.
iDart™ Lyme ImmunoBlot Kits by IGeneX IgG ImmunoBlot (FDA-cleared in late 2024)
iDart™ Lyme ImmunoBlot Kits by IGeneX IgG ImmunoBlot (FDA-cleared in late 2024) IgM ImmunoBlot (FDA-cleared July 2025)
