New Lyme Blood Test LymeSeek Promises Earlier, More Accurate Diagnosis
Current Lyme testing often misses early disease.
A new test called LymeSeek may improve detection accuracy.
Researchers are evaluating whether it can identify Lyme disease earlier and more reliably.
A New Approach to Lyme Disease Testing
Lyme disease is one of the few infections where patients are often diagnosed too late—not because they waited, but because testing could not detect the infection until later stages, if at all.
A new Lyme blood test called LymeSeek could represent an important advance in Lyme diagnostics, particularly for early disease detection where current testing often falls short.
Holly Ahern, MS, MT, Chief Scientific Officer at Aces Diagnostics, discusses LymeSeek. For more information, visit acesdiagnostics.com/lymeseek
According to data presented at the 2025 Association for Diagnostics and Laboratory Medicine meeting, LymeSeek demonstrated over 90% sensitivity and specificity in detecting Lyme disease across all phases of illness—from early localized to post-treatment.
That’s a significant improvement over standard two-tier testing, which often misses early cases when treatment matters most.
Reliable testing is particularly important since an estimated 30% of patients never develop the classic bull’s-eye rash, which many practitioners rely on for diagnosis.
Why Current Lyme Testing Often Fails
Current Lyme disease tests miss many infections—especially early ones—mainly because of how they work and what they’re looking for.
They Don’t Detect the Bacteria Itself
Most current tests, including CDC-recommended two-tier testing, look for antibodies your immune system produces against Borrelia burgdorferi.
However, antibodies may take days to weeks to develop. As a result, serologic testing can produce false negatives—especially during the first 2–4 weeks after infection.
The CDC’s Recommended Two-Tier System Was Not Designed for Early Detection
Patients are initially given an ELISA test. If positive or equivocal, they then receive a Western blot. If either test is negative, patients may be told they do not have Lyme disease—even when clinical suspicion remains high.
The two-tier system was originally developed primarily for surveillance and standardization rather than highly sensitive early diagnosis.
Borrelia‘s Biology Makes Testing Difficult
The bacteria changes the proteins it expresses at different stages of infection, meaning antibody targets are not always consistent.
It may also evade immune detection by hiding within tissues, delaying or blunting antibody production.
Strain and Species Variation
Most U.S. tests focus primarily on Borrelia burgdorferi sensu stricto. If infection involves other species such as B. mayonii, B. garinii, or B. afzelii, testing may fail to detect relevant antigens.
Past Infection vs. Active Infection Confusion
Once antibodies develop, they may remain detectable for months or years after treatment.
As a result, current testing cannot reliably distinguish between new infection, persistent immune response, or past resolved infection.
What Makes This New Lyme Blood Test Different?
The new Lyme blood test uses a multiplexed antigen assay that evaluates 10 different immune responses simultaneously. A machine learning algorithm then interprets the combined data.
This approach aims to improve both sensitivity and specificity, particularly in early disease when antibodies are still developing.
In the reported study population, LymeSeek detected 100% of early Lyme cases (0–72 hours after erythema migrans rash onset) compared with 37% using standard testing.
In post-treatment Lyme disease cases occurring 6 or more months after infection, LymeSeek identified 97% of cases versus 46% with standard testing.
These findings suggest improved detection without waiting for full seroconversion and potentially better recognition of prior exposure in patients with persistent symptoms.
Will This Test Change Lyme Disease Care?
Possibly—but several important steps remain.
This new Lyme blood test may eventually help:
- Identify Lyme disease earlier in infection
- Support diagnosis when no rash is present
- Improve confidence in clinically challenging cases
- Address some limitations of current testing approaches
Is the New Lyme Blood Test Available Now?
No. LymeSeek is not yet FDA-approved or commercially available for routine patient testing.
ACES Diagnostics is currently working with the FDA on clinical trial pathways.
The test has received a De Novo classification, meaning it is being evaluated as a novel diagnostic platform rather than simply compared with existing assays.
If approved, LymeSeek could improve early Lyme detection and help address some limitations of current testing.
Frequently Asked Questions
How accurate is the LymeSeek blood test?
According to preliminary data presented at a 2025 diagnostics meeting, LymeSeek demonstrated over 90% sensitivity and specificity across multiple stages of Lyme disease.
Can LymeSeek detect early Lyme disease?
In the reported study population, LymeSeek detected 100% of early cases compared with 37% using standard testing.
Is LymeSeek available for patients now?
No. The test is not yet FDA-approved or commercially available.
How does LymeSeek differ from current Lyme tests?
LymeSeek uses a multiplexed antigen assay combined with machine learning analysis rather than relying solely on traditional antibody testing.
Will LymeSeek replace the two-tier testing system?
It is too early to know. Regulatory review, independent validation, and broader clinical adoption would still be required.
Clinical Takeaway
LymeSeek will not solve every challenge associated with Lyme disease diagnosis.
However, preliminary findings suggest that newer testing approaches may improve early detection and help address some limitations of current two-tier testing.
For patients who never develop a rash or who test negative despite compatible symptoms, advances in diagnostics could eventually provide earlier answers and greater diagnostic confidence.
Related Reading
References
- Centers for Disease Control and Prevention. Clinical Testing and Diagnosis for Lyme Disease. Accessed 2025.
- Inside Precision Medicine. Blood Test for Lyme Disease Achieves Over 90% Diagnostic Accuracy. Accessed 2025.
- ACES Diagnostics. LymeSeek – Advanced Lyme Disease Diagnostic. Accessed 2025.
Dr. Daniel Cameron, MD, MPH
Lyme disease clinician with over 30 years of experience and past president of ILADS.
Symptoms • Testing • Coinfections • Recovery • Pediatric • Prevention
